Background: Fermented foods vary significantly by food substrate and regional consumption patterns. Although they are consumed worldwide, their intake and potential health benefits remain understudied. Europe, in particular, lacks specific consumption recommendations for most fermented foods. Objective: This project, which is under the framework of the Promoting Innovation Of Fermented Foods (PIMENTO) Cooperation in Science and Technology (COST) Action (CA20128), aims to develop a validated tool to quantitatively estimate fermented food intake across 4 European regions. Methods: The Fermented Food Frequency Questionnaire (3FQ) was designed to quantify fermented food intake in terms of frequency and quantity. Fermented foods were categorized into broad groups (eg, dairy, plant-based, meat, beverages) based on product classifications, ensuring that the foods included were genuinely fermented through ingredient analysis according to the International Scientific Association for Probiotics and Prebiotics consensus for fermented foods as a guide. For each main fermented food group, subcategories were determined after detailed discussions by a scientific expert panel that provided country-specific examples. For example, for hard cheeses, Parmigiano was chosen in the Italian version, and Graviera in the Greek version. The questionnaire was developed in English (universal version) and then translated into multiple languages using the back-translation method. Each version was pilot-tested for clarity, and data for the prospective validation were gathered. This included two key steps: (1) assessing repeatability by having participants retake the questionnaire after 6 weeks and (2) confirming accuracy by comparing 3FQ results against 24-hour dietary recalls from a subsample of participants. Statistical analyses will be used to confirm agreement between the methods. Representative sample calculations were performed for 4 groups by biological sex and age group (between 18 and 49.9 years and 50+ years). To ensure representative sample obtainment, participants aged 18+ years were recruited via the internet using multiple strategies, including social media platforms in all countries, snowball sampling, and potential supplementation with panels provided by the survey platform. Prior to all responses, participants were asked to provide informed consent and agree to data collection under ethical guidelines using a General Data Protection Regulation–compliant platform. Results: A representative sample of 1536 participants per European region was targeted, ensuring diversity in age and sex, with the goal of achieving a 60% response rate. A multilingual questionnaire was developed and pilot-tested for clarity. The upcoming steps will include final validation for accuracy and repeatability using 24-hour dietary recalls and specific statistical techniques of analysis to ensure reliability. Conclusions: The validated web-based 3FQ aims to address the current gaps in fermented food intake to help improve future research in this important area.

Background: Approximately 69% of Americans with spinal cord injury (SCI) have neuropathic pain. Research suggests that impairments in mental body representations (MBRs; ie, representations of the body in the brain) likely contribute to neuropathic pain. Clinical trials in adults with SCI, focused on restoring MBR, led to improvements in sensation and movement as well as neuropathic pain relief. Scales measuring aspects of MBR exist, but none of them assess SCI-related MBR impairments. Objective: As our first aim, we will generate items for a new MBR scale for adults with SCI (the SCI-BodyMap). As our second aim, we will assess the interrater reliability, test-retest reliability, concurrent validity, face validity, and utility of the SCI-BodyMap. Methods: Our preliminary work will encompass initial item generation by SB, an Italian physical therapist (PT) specialized in cognitive multisensory rehabilitation, which is a therapeutic approach that focuses on restoring MBR in adults with neurological disorders and chronic pain. Further item refinements will be carried out by Italian PTs (n=7) and Brazilian PTs (n=3) specialized in cognitive multisensory rehabilitation. In aim 1, American PTs or occupational therapists (n=8) and adults with SCI (n=8) will provide feedback on the SCI-BodyMap. Next, American PTs or occupational therapists (n=3) will administer the SCI-BodyMap to adults with SCI (n=3) and provide more feedback during an in-person visit. In aim 2, four assessors will administer the SCI-BodyMap to adults with SCI (n=30) for interrater reliability. The self-report items will be administered at 2 separate time points to assess test-retest reliability. We will also administer the SCI-BodyMap to uninjured adults (n=30) to identify whether healthy adults score statistically different on the scale than adults with SCI. We will assess concurrent validity through correlations between the MBR scale, the Revised Body Awareness Rating Questionnaire, and the Multidimensional Assessment of Interoceptive Awareness-2. Results: As of August 2025, we have enrolled 8 PTs or occupational therapists and 8 adults with SCI for aim 1 as well as 29 adults with SCI and 13 uninjured adults for aim 2. Conclusions: A reliable and valid MBR scale is needed to identify MBR deficits and evaluate intervention effects on MBR outcomes in adults with SCI. Improving MBR can lead to safer, more efficient day-to-day activities (eg, transfers); promote functional independence and quality of life; reduce neuropathic pain and spasms; and improve sensorimotor function.

Background: Various media are used to enhance public understanding about diseases. While mobile health apps are widely used, there is little proof for using such apps to raise awareness of skin diseases. Objective: We intend to develop an app, called DEDIKASI-app, to raise awareness of skin diseases, including leprosy. The study will explore baseline awareness, assess the app’s acceptance by community members and health care workers, and evaluate its effectiveness in enhancing awareness about skin diseases. Methods: The study will be conducted in four phases: (1) development of DEDIKASI-app, (2) questionnaire development for an awareness study, (3) acceptability testing, and (4) effect measurement of DEDIKASI-app. We will adopt design thinking methodology to develop the app, involving systematic reviews, expert consultations, focus group discussions, and validation of the questionnaire on skin disease awareness. We will recruit 50 members of the community for the awareness and acceptability study and 1 health care worker per community health center to assess their perception of the app. A pilot study will assess the acceptability of DEDIKASI-app among community members and health care workers based on various constructs, with responses categorized as positive, negative, or undecided. The validity and reliability of a newly developed questionnaire on skin disease awareness will be tested, with validity results analyzed qualitatively and reliability measured using Cronbach α. The effectiveness of DEDIKASI-app in improving community awareness will be evaluated through a randomized controlled trial, using total scores, means, and SDs for control and intervention groups. Statistical significance of awareness level changes will be determined by delta change (P value), with P<.01 considered significant. Results: This study received ethical approval from the Ethics Review Board of the Faculty of Public Health, Universitas Airlangga (160/EA/KEPK/2023) and was registered in the Indonesia Clinical Research Registry (INA-O8EX278). Funding for the field research was secured in the period of May 2022-December 2024 from NLR Indonesia and Erasmus University Medical Center. As of manuscript submission, phase 1 (app development) and phase 2 (questionnaire development) have been completed. Data collection for the randomized controlled trial has just finished and data analysis is ongoing, with publication of the study results expected in late 2025. Conclusions: Innovative approaches are required to enhance awareness in the community. This study will introduce new tools and insights to address the limited knowledge about detecting skin problems. Trial Registration: INA-CRR Indonesia Clinical Research Registry INA-O8EX278; https://tinyurl.com/ms3k5yvn

Background: With the availability of more advanced and effective treatments, life expectancy has improved among patients with metastatic breast cancer (MBC), but this makes communication with their medical oncologist more complex. Some patients struggle to learn about their therapeutic options and to understand and articulate their preferences. Mobile health (mHealth) apps can enhance patient-provider communication, playing a crucial role in the diagnosis, treatment, quality of life, and outcomes for patients living with MBC. Our team developed an app called My MBC Journey to focus on the collection of important information for patients with MBC between clinical encounters. Objective: This study will evaluate the usability and satisfaction of My MBC Journey, a mobile app designed for MBC, to inform future modifications. Methods: This mixed methods study will assess patient use and satisfaction with the My MBC Journey app to inform future app modifications and identify the barriers and facilitators to the app’s use for enhancing patient-provider communication. We will recruit a prospective, cross-sectional convenience sample of 25 patients with MBC and a sample of 15 members of the care team (ie, caregivers, nurse navigators, and medical oncologists). Applying iterative, convergent mixed methods, we will conduct qualitative, semistructured interviews with the patients and care team members. We also will collect quantitative data on usability through app analytics and standardized questionnaires (ie, the Mobile Application Rating Scale, the Mobile Application Rating Scale user version, and the System Usability Scale). Qualitative interviews will be audio recorded and analyzed using NVivo software to identify mHealth implementation themes. Results: The study’s results will inform future app design modifications and gauge preliminary effect size in support of future evaluations of the app’s efficacy in improving patient-provider communication. Conclusions: Our long-term goal is to improve patient-provider communication by developing mHealth apps that empower patients to collect and share clinically relevant, patient-reported information in a timely manner.

Background: Youth who are experiencing homelessness face a higher risk of HIV infection compared to their housed peers, and suicide and overdose remain the leading causes of death among homeless youth. Just-in-Time Adaptive Interventions (JITAIs) are gaining momentum for HIV prevention and substance use research. Yet, most interventions for homeless youth have not addressed modifiable real-time factors. Objective: This paper describes the development and implementation of a randomized attention-controlled trial to assess the efficacy of motivating youth to reduce infections, disconnections, and emotional dysregulation (MY-RIDE), a JITAI to improve HIV prevention and substance use in homeless youth. Methods: This study will enroll 320 homeless youth aged 18-25 years. The intervention was co-designed with homeless youth using the Information-Motivation-Behavioral Skills Model and consists of an individual nurse-led session about HIV prevention and 3 months of a JITAI with personalized messaging delivered by phone in real time in response to one’s current level of risk. Participants also had access to an on-demand nurse helpline through the app. Results: Institutional review board approval was obtained in the summer of 2024. Recruitment began in the fall of 2024 at shelters, drop-in centers, and other organizations that serve homeless youth. Participants complete a baseline survey and HIV/sexually transmitted infection (STI) testing and are provided with a smartphone with the intervention app. Follow-up surveys and HIV/STI testing are conducted at immediate, 3-, 6-, and 12-month time points post intervention to assess uptake of HIV prevention strategies and substance use reduction. A total of 192 are enrolled to date. Conclusions: The results of this study will determine whether MY-RIDE increases HIV prevention strategies and decreases substance use when compared to homeless youth in the attention control group. We will also evaluate if MY-RIDE impacts protective factors such as willingness to take pre-exposure prophylaxis medication and use of mental health and substance use services, and antecedents of risk such as stress, substance use urge, and substance use. Trial Registration: Clinicaltrials.gov NCT06074354; https://clinicaltrials.gov/study/NCT06074354

Background: In-hospital cardiac arrest (IHCA) remains a public health conundrum with high morbidity and mortality rates. While early identification of high-risk patients could enable preventive interventions and improve survival, evidence on the effectiveness of current prediction methods remains inconclusive. Limited research exists on patients’ prearrest pathophysiological status and predictive and prognostic factors of IHCA, highlighting the need for a comprehensive synthesis of predictive methodologies. Objective: This scoping review aims to synthesize and critically evaluate the quality and quantity of clinical features and machine learning (ML) models for predicting IHCA. The review will evaluate temporal characteristics, predictive and prognostic values of prearrest clinical features, and model performance metrics. Methods: This scoping review follows the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and aims to synthesize studies that used ML algorithms to predict IHCA published between April 2009 and April 2024. We will conduct a comprehensive search using 4 major databases: PubMed, Web of Science, IEEE Xplore, and Embase. The inclusion criteria are peer-reviewed, English-language studies that explore ML applications for predicting IHCA in adult patients (aged ≥18 years). Exclusion criteria include review articles, preprints, non–English-language studies, and studies without specific ML metrics for IHCA prediction. Two independent reviewers will conduct the screening and data extraction using Rayyan for deduplication and ensuring study eligibility. Descriptive statistics will be used to summarize the data, and a narrative synthesis will provide insights into the clinical features used in the models, the performance metrics, and any gaps in the literature. Results: A total of 2479 records were identified between April 2009-April 2024. After removing duplicates and conducting screening, 16 studies have been included in the review. Data extraction and synthesis are ongoing and are expected to be completed by June 2025. The anticipated results from this review will provide a comprehensive overview of the clinical predictors of IHCA used in ML models, including commonly reported clinical features such as vital signs, biomarkers, and comorbidities. We expect to highlight variations in data quality and quantity across studies, which may influence model performance. Conclusions: This study will contribute to advancing ML applications for IHCA prediction by addressing data challenges and promoting standardization to improve the clinical decision-making process. The results of this review are expected to inform future studies; promote consistency in the reporting of clinical features; and, ultimately, enhance the decision-making process in clinical settings, potentially leading to better outcomes for patients experiencing IHCA.

Background: In Canada, the Indigenous population is the youngest and fastest growing, yet ongoing health disparities for Indigenous peoples are widely recognized. There is a concerning lack of research on childhood disabilities and health conditions in Indigenous populations in Canada. For children with disabilities and chronic health conditions, ongoing access to rehabilitation services, such as occupational therapy, physical therapy, speech-language pathology, and audiology, is critical in promoting positive health and developmental outcomes. Elders and the Peter Ballantyne Cree Nation health services board have guided a critical priority for addressing access challenges to pediatric rehabilitation in 3 specific northern Indigenous communities. Objective: The purpose of this manuscript is to outline the protocol for a community-directed needs assessment and subsequent development of a multidisciplinary pediatric rehabilitation service in 3 specific northern Indigenous communities. Methods: The study involves 3 phases. In phase 1, the needs assessment process was led by 2 physiotherapy clinician researchers and 2 graduate students working with health care professionals in pediatric speech-language pathology, audiology, physiotherapy, and occupational therapy with experience in both private and public health entities. The process consisted of multiple parts, which included a community-led request, a preliminary literature review, survey development, interview guide development, communication and feedback with health care professionals, a test phase with pediatric family members, and finalization of the survey and interview guides for deployment. In phase 2, the findings from phase 1 will inform the codevelopment of a pilot hybrid-care, interprofessional pediatric rehabilitation clinic for each of the communities. In phase 3, a stakeholder meeting will take place to facilitate knowledge sharing and open discussion regarding the implementation of phase 2 as well as considerations for the sustainability of this model of care. Results: The final survey was multidisciplinary, with 6 content areas covered in 15 items. Guides for 1-on-1 interviews and sharing circles included 10 questions for community members and 12 questions for health care providers. Participant recruitment began in April 2024. Final results are anticipated in early 2026. Conclusions: This manuscript details the process of a community-directed needs assessment, which will inform the development and implementation of a model of care for pediatric rehabilitation services. Our process was driven by a request from the community for a needs assessment and emphasized the involvement of key stakeholders early and often during assessment development. A clear purpose of the project was identified with community direction. We used multidisciplinary inputs from both public and private sectors and maintained clear goals during our survey question design process. This study aims to inform the codevelopment and implementation of an interdisciplinary, hybrid model of pediatric rehabilitation care for remote First Nation communities, ultimately leading to improved access to patient- and family-centered care for pediatric rehabilitation.

Background: Electronic health records (EHRs) have been linked to information overload, which can lead to cognitive fatigue, a precursor to burnout. This can cause health care providers to miss critical information and make clinical errors, leading to delays in care delivery. This challenge is particularly pronounced in medical intensive care units (ICUs), where patients are critically ill and their EHRs contain extensive and complex data. Objective: We propose to study the effect of an information visualization dashboard on ICU providers’ cognitive fatigue in 4 major US medical centers. In this randomized controlled trial, we will compare 2 leading EHRs with a visualization dashboard–based EHR called AWARE. Methods: This crossover randomized trial will collect physiological and objective data using a screen-mounted eye-tracking device to assess cognitive fatigue among ICU providers. The study will involve 120 ICU providers from 4 US medical centers, with each site using its institutional EHR as the control and the AWARE EHR as the intervention. Participants will be randomly assigned to use either their institutional EHR or the AWARE EHR first, followed by the other EHR, with the order of EHR use and patient case order randomized by the study team. The AWARE tool is designed to integrate within an existing EHR system and provides clinical support tools, such as the ability to trend data points from body systems at a glance. Data analysis will include eye-tracking metrics, performance measures, and validated surveys to evaluate EHR usability and its impact on clinical decision-making. Primary outcomes include the number of cognitive fatigue instances per patient case, time to complete each case, overall usability of the session, number of mouse clicks per case, provider performance scores from questions asked during each patient case, and perceived usability of each EHR. Secondary outcomes include the number of eye fixations per patient case and perceived workload of each EHR. Results: This EHR usability study was funded in 2021 and initiated in 2022, with a completion date of 2025. Data collection began in August 2023. As of now, 3 of the 4 study sites have completed data collection, with a total of 113 completed sessions thus far. Data collection is ongoing at the fourth site. Preliminary analysis is ongoing, and we expect to begin publishing results in late 2025. Conclusions: Findings from this research may inform improvements in EHR interface design and usability, which may enhance provider performance, streamline care delivery, and improve patient safety outcomes. Clinical Trial: ClinicalTrials.gov NCT05937646; https://clinicaltrials.gov/study/NCT05937646

Background: Cancer screening nonadherence persists among adults who are deaf, deafblind, and hard of hearing (DDBHH). These barriers span individual, clinician, and health care system levels, contributing to difficulties understanding cancer information, accessing screening services, and following treatment directives. Critical communication barriers include ineffective patient-physician communication, limited access to American Sign Language (ASL) cancer information, misconceptions about medical procedures, insurance navigation difficulties, and intersectional barriers for multiply marginalized individuals. Objective: This randomized controlled trial addresses these barriers by implementing the first videoconference-based study of ASL-fluent community health navigators (ASL-CHNs) to improve cancer screening adherence among adults who are DDBHH. The study tests whether ASL-CHN intervention results in greater adherence to cancer screening guidelines, improved patient-physician communication ratings, and increased cancer knowledge compared to standard care. Methods: The study uses a videoconference-delivered, block-randomized design stratifying 200 participants who are DDBHH by age and sex, with 100 participants assigned to the ASL-CHN intervention and 100 to standard care. All participants are confirmed as nonadherent to at least 1 of 5 age-appropriate cancer screening guidelines recommended by the United States Preventive Services Task Force for breast, cervical, colorectal, lung, and prostate cancers. Recruitment occurred nationwide through multiple strategies including prior study participants, community partners, and major community events. The intervention arm receives support from specially trained ASL-CHNs over several months, accommodating lengthy scheduling processes for cancer screenings. Primary outcomes measure completion of age- and risk-appropriate cancer screening, with prostate cancer focusing on shared decision-making participation. Secondary outcomes assess patient-physician communication using the validated National Cancer Institute’s Health Information National Trends Survey (NCI-HINTS) Patient Centered Communication questionnaire in ASL. Tertiary outcomes examine cancer knowledge through validated measures. The analysis uses intent-to-treat methodology using multivariable logistic regression, accounting for potential clustering effects and anticipated 25% attrition. Results: As of August 2025, more than 75% of the target enrollment has been achieved. Preliminary data indicate that the intervention group is consistently outperforming the standard care group in cancer screening adherence, supporting the study hypothesis that ASL-CHNs are effective in promoting cancer screening adherence among previously nonadherent participants who are DDBHH. Conclusions: The ASL-CHN intervention represents an accessible, scalable solution for reducing cancer screening disparities. By combining personalized navigation with ASL-fluent community health support through videoconferencing, this intervention addresses limitations of previous screening programs that lacked accessible support. If successful, the ASL-CHN model could provide health care providers with a practical, recommendable option for patients who are DDBHH requiring navigator support that can be done remotely through videoconferencing, potentially improving early detection rates and reducing cancer mortality in this underserved population while advancing accessible care delivery. Trial Registration: ClinicalTrials.gov NCT06492993; https://clinicaltrials.gov/study/NCT06492993

Background: In the United States, cancer is more prevalent in racial and ethnic minority groups and in rural-dwelling and low-income people. Compared with White people of non-Hispanic descent, Black and African American people have higher cancer mortality and Hispanic people are more likely to be diagnosed with infection-related cancers. In addition, people who live in persistent poverty areas are more vulnerable to cancer mortality. Tailoring health information technologies (HITs) can help bridge health inequities by providing these populations with relevant health information and cancer care. Cultural tailoring in health care involves adapting interventions to reflect a population’s values, history, and attitudes that influence behavior. Objective: The goals of the current study are as follows: 1) to understand what elements of tailoring HITs are most effective among different underserved populations, 2) to identify ways of incorporating these elements to improve the acceptability and effectiveness of technology-based interventions, and 3) to develop a framework to tailor HITs to underserved populations and improve engagement and acceptability. Methods: A scoping review will explore how HITs have been culturally tailored to underserved populations using PubMed, Scopus, and Web of Science database searches. Our search strategy will include terms and medical subject headings associated with the categories of cancer, HITs, tailoring, and underserved populations. We will also perform a snowball search of the references of included studies. We will include quantitative and qualitative peer-reviewed, English-language studies from the United States that examine efforts to tailor HIT interventions to improve their acceptance, use, and usability among underserved populations. Predefined inclusion and exclusion criteria will be applied for study selection. For each included study, we will extract the following data: study design, cancer type, underserved population of interest, details of the technology used, study methods, sample size, study outcomes, user acceptability, and tailoring and targeting strategies. The data will be summarized descriptively and analyzed thematically. Results: Preliminary searches following this strategy yielded a total of 784 citations (after removing duplicates) that will each be reviewed by at least 2 reviewers for inclusion. This protocol was submitted before data collection. The search strategy, citation screening, and data extraction will commence in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines and the published protocol. Findings will be expected by the spring of 2026. Conclusions: There is a need to develop more accessible HITs for underserved populations. This scoping review will inform researchers, providers, and developers working on cancer-specific HITs for underserved populations, such as racial and ethnic minority groups, rural-dwelling residents, and low-income populations. By summarizing evidence on tailoring strategies by population and delivery mode, the review aims to support the development of more effective and acceptable technologies.

Background: Sarcomas are rare cancer with a heterogeneous group of tumors. They affect both genders across all age groups and present significant heterogeneity, with more than 70 histological subtypes. Despite tailored treatments, the high metastatic potential of sarcomas remains a major factor in poor patient survival, as metastasis is often the leading cause of death. Currently, metastatic risk assessment relies mainly on histological grading; yet, this method has limitations due to the disease’s heterogeneity. Advances in genomic and transcriptomic research have identified potential molecular signatures, but these approaches lack reproducibility and prognostic reliability. Therefore, new biomarkers are essential for improving risk prediction and therapy adaptation. Recent studies highlight that sarcoma cells secrete extracellular vesicles, particularly small extracellular vesicles (sEVs). These nanovesicles, abundant in bodily fluids such as blood, urine, and saliva, play a crucial role in tumor development, growth, and metastasis. sEVs contain proteins and nucleic acids that mirror tumor characteristics. Given their presence in blood, sEVs offer a promising avenue for noninvasive molecular cancer analysis via liquid biopsy. Preliminary studies in Ewing sarcoma have shown substantial alterations in sEV-derived transcripts, underscoring their potential in tracking disease progression and treatment efficacy. Objective: This study aims to investigate whether sEVs can serve as reliable biomarkers for monitoring sarcoma progression and predicting recurrence risk. Methods: This prospective, multicentric pilot study will enroll adult patients diagnosed with localized or metastatic liposarcomas, leiomyosarcomas, or undifferentiated pleomorphic sarcomas at 3 French cancer centers. The study’s primary goal is to quantify sEVs and analyze their protein and RNA content in the blood of patients with localized or metastatic sarcomas before and after the treatment. sEVs will be isolated from plasma samples, and protein and microRNA concentration will be determined. Research will last, on average, 6 months for patients with localized sarcoma and 4 months for patients with metastatic sarcoma. Results: We expect to identify differences in exosome levels based on disease stage and observe correlations between exosome dynamics and treatment response. If confirmed, these findings could establish sEVs as noninvasive biomarkers for monitoring therapy effectiveness and disease progression in patients with sarcoma. Conclusions: This study could establish a novel, noninvasive biomarker for sarcoma prognosis and treatment monitoring. If successful, a nationwide study will be launched to confirm findings in a larger patient cohort, potentially revolutionizing sarcoma management and improving patient outcomes. Clinical Trial: ClinicalTrials.gov NCT03800121; https://clinicaltrials.gov/ct2/show/study/NCT03800121

Background: Youth in the United States are experiencing rising rates of anxiety, depression, and other mental health challenges, yet many remain underserved due to systemic barriers such as poverty, limited access to care, and shortages in the mental health workforce. Schools and primary care clinics are trusted, community-based settings that offer strategic opportunities for early identification, prevention, and intervention. As part of a public health approach, integrating digital mental health tools into these settings can support broad access, enhance mental health literacy, and promote help-seeking behaviors among all students. When co-designed with youth and embedded within existing care systems, these tools offer a scalable, proactive solution to support well-being across diverse school-aged populations. Objective: This protocol describes the design and implementation of a stepped-wedge clinical trial to evaluate the Connected for Wellness mobile app, a youth- and caregiver-facing digital mental health intervention. Developed using participatory informatics and human-centered design principles, the app provides culturally relevant content in English and Spanish. Features include self-guided wellness activities, well-being screeners, psychoeducational videos, and localized service directories. Machine learning algorithms personalize content recommendations based on user inputs and behavioral patterns. Methods: This trial uses a stepped-wedge cluster randomized design across 20 community-based sites (10 high schools and 10 primary care clinics) in 2 counties in California. These counties were selected for their high proportions of underserved youth populations. All youth aged 13 to 22 years and their caregivers will be invited to access the app. Sites are randomized into 2 implementation waves. The app is introduced site-wide as a universal public health intervention supported by on-site navigators and peer ambassadors. The primary outcomes are derived from a cascade-of-care framework, including identification of mental health need, referral to services, initiation of services, and engagement (defined as ≥3 treatment visits). Data will be collected via anonymous in-app analytics, monthly World Health Organization–Five Well-Being Index assessments, and deidentified electronic health and administrative records. Generalized linear mixed models will be used to evaluate differences in cascade outcomes between pre- and postimplementation phases while accounting for clustering and site-level variability. Results: As of May 2025, the mobile app has been finalized, institutional review board approvals have been secured, and all study sites have been recruited. Participant recruitment is projected to begin in August 2025. Data collection and initial analyses will begin in early 2026, with preliminary findings expected by October 2026. Conclusions: This study tests a novel digital health intervention integrated into trusted care systems. If effective, the Connected for Wellness mobile app may serve as a scalable strategy to reduce disparities in mental health care access and engagement for youth across the United States. Trial Registration: ClinicalTrials.gov NCT06122688; https://clinicaltrials.gov/study/NCT06122688

Background: Needs assessments in patients with juvenile idiopathic arthritis (JIA) have revealed a need for disease information, self-management skills, and peer support. We previously developed and tested the acceptability of an in-person and videoconference-based self-management program (SMP) to address these needs. Objective: The aim of this pilot randomized controlled trial (RCT; the VISTA-JIA trial) is to evaluate the feasibility and preliminary effectiveness of a virtual group-based SMP for adolescents with JIA in comparison to a waitlist control group. Methods: A total of 100 participants with confirmed JIA (aged 12-17 years) will be recruited from 5 Canadian pediatric rheumatology centers and randomized 1:1 to the intervention or waitlist control groups. Adolescents in the intervention group will receive the virtual SMP. Those randomized to the control group will receive standard of care alone and will later be eligible for the SMP. The SMP includes JIA disease education, self-management strategies, and peer support. Four 60- to 90-minute sessions will be conducted over 8 weeks with a group size of 4-6 participants. The primary feasibility outcome will be adherence to the SMP (defined as completion of all 4 sessions by at least 80% of participants). Other secondary feasibility outcomes will include recruitment and withdrawal rates, the proportion of completed questionnaires, engagement and satisfaction with the SMP measured through a semistructured virtual interview, and intervention fidelity (consistent content and technology delivery). Secondary preliminary effectiveness outcomes will be assessed by completing 5 validated questionnaires at pre- and postprogram time points: (1) the Medical Issues, Exercise, Pain, and Social Support Questionnaire to assess perceived ability to manage JIA (self-management); (2) the Children’s Arthritis Self-Efficacy Scale to assess self-efficacy; (3) the Pediatric Quality of Life Inventory 3.0 Rheumatology–Teen Module to assess health-related quality of life; (4) the PROMIS (Patient-Reported Outcomes Measurement Information System) Pediatric Pain Interference Scale to assess pain interference; and (5) Readiness for Adult Care in Rheumatology to assess transition readiness. Descriptive statistics and nonparametric tests will be used to analyze the data. Results: The study setup is complete at all centers, including training of the facilitators, revising and finalizing education sessions, participant’s handout guide, and fidelity checklist. Recruitment began in January 2024 and is expected to conclude by December 2025. Feasibility outcomes, including adherence and engagement, as well as preliminary effectiveness, will be analyzed post intervention. Conclusions: This is the first evidence-based, virtual, interactive, group-structured JIA SMP in Canada. This SMP will address needs for disease information, self-management skills, and peer support in adolescents with JIA. The results of this pilot study will inform a full-scale RCT focused on the efficacy and cost-effectiveness of the program with the goal of integration in routine clinical practice across Canada. Trial Registration: ClinicalTrials.gov NCT06184100; https://clinicaltrials.gov/study/NCT06184100

Background: Substance use rates among sexual minorities are disproportionately greater than that of their heterosexual counterparts. Minority stress theory posits that one explanation for disproportionate substance use in sexual minority populations is a result of increased social stress associated with holding a minoritized identity. This minority stress has been linked to a myriad of negative mental health outcomes, including alcohol and drug use. In addition, emerging research has begun to demonstrate links between minority stress and stress physiology dysregulation. While animal and human models have demonstrated links between stress physiology dysregulation and substance use outcomes, to date, no studies have examined the role that stress physiology plays within a minority stress framework in predicting substance use among sexual minorities. The Queer Health Study was designed to explore the longitudinal links among minority stress, stress physiology (specifically, allostatic load, the cumulative “wear and tear” on the body and brain as a result of chronic stress), and substance use. Objective: This study aims to assess the feasibility of collecting longitudinal data to explore the temporal links between minority stress processes, allostatic load, and drug and alcohol use, as well as to obtain estimates of effect size to determine the appropriate sample size necessary to conduct a fully powered longitudinal study. Methods: This feasibility study is a 3-wave longitudinal design consisting of a self-report survey, researcher-assisted Timeline Followback to assess for drug and alcohol use, and blood and anthropometric data collection to measure allostatic load at each of the time points. A total of 40 ethnically and racially diverse sexual minority adult participants (aged 18-60 years) will be enrolled. Results: The study received University of Houston institutional review board approval on July 31, 2023 (STUDY00004277). Recruitment began in June 2024. As of February 2025, the initial sample of 46 participants completed the time 1 visit, and time 2 visits are ongoing. We estimate that all study activities will be completed by July 2025. Conclusions: Results can inform the development of targeted prevention and treatment interventions. In addition, this research will provide an innovative framework for exploring diverse risk and resilience factors impacting addiction in this at-risk population. Ultimately, results have important implications for public health and have the potential to reduce the many dire economic and health consequences of drug use and addiction.

Background: Abdominal pain is a common reason for children to attend the Emergency Department (ED) with acute appendicitis being the most common surgical cause. Various clinical prediction scores (CPSs) have been developed to assist in determining the risk of appendicitis; however, CPSs have been inadequately validated in children and haphazardly adopted in Australia and New Zealand (ANZ) EDs. Objective: This study aims to compare and validate various CPSs for diagnosing pediatric appendicitis in children presenting to ANZ EDs. Methods: This prospective multicenter observational study across 10 ANZ EDs is recruiting children 5-17 years presenting to participating EDs with acute right-sided or generalized abdominal pain lasting ≤7 days and clinician suspicion of appendicitis. CPSs will be calculated by the study team from clinician-recorded data and clinician gestalt recorded on a visual analog scale. Accuracy of CPSs will be assessed by the area under the receiver operating characteristic curve and proportions correctly identified as either low-risk or high-risk based on the CPSs published cutoffs. The final diagnosis of appendicitis will be confirmed on histopathology, and the absence of appendicitis confirmed by telephone, email, or a combination of both to follow up for those discharged directly from ED. Results: This study received funding in July 2023 and started enrolment in August 2023. As of October 2024, we have enrolled and completed follow-up on 1227 participants with an expected end date in mid-2025. Conclusions: This study aims to determine the best-performing CPS for diagnosing pediatric appendicitis in ANZ EDs. Implementation of this CPS in ANZ EDs has the potential to reduce health care costs, rationalize the use of health care resources, and improve the management and outcomes of childhood appendicitis. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622001293752; https://tinyurl.com/242wwenx

Background: Miscommunication in health care is a major source of poor health outcomes, complaints about health care professionals, and poor patient satisfaction. Recordings from real-life consultations provide valuable data for communication research and education. Additionally, recordings from simulation-based education of health care students can provide valuable data for health care education research. Objective: The Digital Library is a data repository supporting high-quality health care communication research. This is the single-source citation for all projects that use the Digital Library in Australia. Methods: This protocol outlines the logistics and consent process for recording and safely storing the recordings of health care consultations and simulation-based education. The processes are outlined for primary health care settings and health care educational settings as well as for health care narratives from consumers. The repository will be used to answer research questions about health care communication and provide a valuable resource for health care education. Results: Data collection for the Digital Library commenced in 2023 and is ongoing at the time of submission of this protocol. The Digital Library has been approved by Monash University’s Human Research Ethics Committee. Conclusions: The Digital Library will provide a national resource for the study of health care communication in community settings, general practice, and other environments. The health care narratives may be a valuable resource for sharing the patient perspective when living with different conditions. The research that uses this repository will be shared through regular academic channels as well as the community-based dissemination strategies of the National Centre for Healthy Ageing.

Background: The effects of climate change on mental health are becoming widely recognized. Mental health can be impacted through direct and indirect exposure to natural hazards, as well as through the overarching awareness of climate change and the resultant environmental decline—the latter is termed eco-anxiety. Exposure to natural hazards also increases eco-anxiety, further compounding mental health impacts. Young people are especially vulnerable to the mental health impacts of climate change and have higher rates of eco-anxiety than other age groups. Those in rural areas are also more likely to be impacted by natural hazards, further underscoring the need to support this population. To date, there remains scant evidence regarding how to support young people with eco-anxiety, and few interventions, especially for children, have been evaluated. There is a need for further research to inform treatment for young people for climate change–related distress. Objective: This study pilots a novel group-based mental health and resilience intervention in relation to eco-anxiety. Specifically, this project aims to explore the acceptability, feasibility, and clinical utility of a group-based eco-anxiety intervention. Methods: The project is an exploratory pilot assessing the acceptability, feasibility, and clinical utility of a group-based intervention using a pre-post design with a single group. A minimum sample of 12 children aged 10-14 years located in a rural area and with exposure to at least one natural hazard will be enrolled in this study. In order to assess clinical utility, changes from preintervention to postintervention in distress, resilience, and climate emotions will be assessed. To do so, children will complete measures of psychological distress (subjective units of distress, Depression Anxiety Stress Scale-21–youth version), climate emotions, and resilience (Resilience Scale for Children-10) before and after the intervention. Acceptability will be assessed post intervention through a series of Likert scale and open-ended questions. Feasibility will be assessed through enrollment and the proportion of participants completing the full intervention. Eligible children will take part in a novel 5-module group-based intervention designed to build resilience, promote nature connectedness, build social support, and foster meaning-focused coping. Results: This study has received ethics board approval by the University of New England’s Human Research Ethics Committee (HE23-080). This study will be conducted from late 2024 to 2025. As of March 2025, 28 children have been enrolled in the study. Conclusions: Rural children and young people are an especially vulnerable population for the mental health impacts of climate change. To date, the evidence base for interventions for treating eco-anxiety remains sparse, especially for young people and children who typically have higher rates of eco-anxiety than older age groups. This study will provide preliminary evidence of a group-based treatment for children and adolescents experiencing eco-anxiety that can inform practitioners. Trial Registration: Australia and New Zealand Clinical Trials Registry ACTRN12624001287527; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=388545

Background: Kidney replacement therapy (KRT) is needed by patients with kidney failure to eliminate metabolic waste. When kidney transplantation is not feasible, hemodialysis (HD) is performed. Hemodiafiltration (HDF) provides a better solute clearance than conventional HD due to its higher convective dose. The clearance performances of HDF also depend on the type of dialysis membrane used. Polysulfone (PS) membranes have been used since 1965 due to their excellent resistance and biocompatibility. However, the newer generation of polymethylmethacrylate (PMMA) membranes offers comparable convective capacity with reduced albumin loss. Objective: The forthcoming study aims to compare the solute clearance of postdilution HDF using PMMA versus PS dialyzer membranes in patients with kidney failure requiring long-term HD. Methods: The literature search will use databases including PubMed, Scopus, Web of Science, Embase, and Cochrane. Two independent reviewers will select studies and assess their quality. Pooled estimates of relevant factors will be computed via a random-effects model using Stata/BE 18 (StataCorp) software. The reporting of findings will adhere to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Results: The search and screening for the systematic literature review are expected to be completed in May 2026. Data extraction, quality appraisal, and subsequent data synthesis will begin in June 2026. The review should be completed by October 2026, and the study results will be published in 2027. Conclusions: Dialyzer membrane clearance determines HD quality. Nevertheless, many middle uremic molecules are poorly cleared with conventional HD. Consequently, HDF was invented to improve their clearance. Among the most widely used dialyzer membranes, PS and PMMA are used in the newer generation of HDF. Nevertheless, no available systematic reviews have compared the efficacy of the 2 dialyzer membrane materials. Although no ideal dialyzer can efficiently remove all types of uremic toxins while retaining essential elements, improving solute clearance should benefit patients. This information could help clinicians determine which membrane to use in HDF. Trial Registration: PROSPERO CRD42024603277; https://www.crd.york.ac.uk/PROSPERO/view/CRD42024603277

Background: Black and Latino men are at increased risk for poor diabetes health outcomes but are underrepresented in lifestyle interventions for weight loss and diabetes prevention. Although relatively few men participate in the National Diabetes Prevention Program (NDPP), it remains the most widely available evidence-based approach to type 2 diabetes prevention in the United States. Thus, an NDPP tailored to Black and Latino men has the potential to address prior limitations of NDPP implementation and reduce gender, racial, and ethnic diabetes disparities. It also provides an opportunity to define a population for targeted outreach and evaluate the reach of our recruitment methods and interventions. Objective: We tailored the US Centers for Disease Control and Prevention Prevent T2 curriculum for the NDPP for Black and Latino men, called Power-Up, and will evaluate its effects in comparison to standard mixed-gender NDPP groups via virtual delivery. The primary aim of the project is to assess the effect of Power-Up versus NDPP on weight loss among men with prediabetes. The secondary aim is to compare the engagement and retention of men with prediabetes in Power-Up versus NDPP. We will also examine the reach of our recruitment methods and engagement in our screening, consenting, and assessment procedures prior to the point of randomization. We hypothesized that men randomized to Power-Up would achieve greater percent weight loss from baseline at 16 weeks (end of Core sessions) and 1 year (end of Maintenance sessions) than men randomized to standard, mixed-gender NDPP. Power-Up is also expected to have better engagement and retention. Methods: Using the electronic health record (EHR) systems of a large academic medical center and a network of small to medium independent primary care practices throughout New York City, we identified Black and Latino men who met eligibility criteria for NDPP and enrolled them in a randomized controlled trial in which they were assigned 1:1 to receive Power-Up or the standard, mixed-gender NDPP over 1 year via online videoconferencing. Coaches delivering these interventions were trained according to the standards for the NDPP. Power-Up will be delivered by men coaches. Weight will be collected with home-based electronic scales for primary outcome analyses. Engagement will be assessed by session attendance logs. Results: We identified 11,052 men for outreach based on EHR data, successfully screened 26% of them, consented and enrolled 22% of these, and randomly assigned 48% of consented participants. Primary and secondary outcome analyses will be assessed among randomized men. Conclusions: This study highlights the effort required to reach and engage Black and Latino men for virtually delivered diabetes prevention programs. Forthcoming trial results for weight loss and engagement will further inform efforts to address disparities in diabetes prevention through tailored programming for Black and Latino men. Trial Registration: ClinicalTrials.gov NCT04104243; https://clinicaltrials.gov/study/NCT04104243

Background: Suicide in local jails occurs at a higher rate than in the general population, requiring improvements to risk screening methods. Current suicide risk screening practices in jails are insufficient: They are commonly not conducted using validated screening instruments, not collected by clinically trained professionals, and unlikely to capture honest responses due to the chaotic nature of booking areas. Therefore, new technologies could improve such practices. Several studies have indicated that machine learning (ML) models considerably improve accuracy and have positive predictive value in detecting suicide risk compared with practice as usual (PAU). This study will use administrative data and ML modeling to improve suicide risk detection at jail booking. Objective: This study is primarily focused on gathering preliminary information about the feasibility and practicality of using administrative data and ML modeling for suicide risk detection but also incorporates elements of hypothesis testing pertaining to clinical outcomes. Methods: The study uniquely contributes to our understanding of suicide risk by further validating an existing ML model developed and previously validated by the Mental Health Research Network using Medicaid outpatient health care claims data. This validation uses complete claims data on a sample of approximately 6000 individuals booked into 2 diverse jails in a midwestern state. This model validation uses 313 unique demographic and clinical characteristics from 5 years of historical health care data. It detects suicide risk in jails and postrelease by using merged jail, Medicaid, and vital records data. The study will use jail administrative data for September 1, 2021, through February 28, 2022; Medicaid records data for September 1, 2016, through March 31, 2023; and vital records data for March 1, 2022, through March 31, 2023. Results: First, the algorithm will be validated on the data gathered for the jail sample using the C-statistic and area under the receiver operating characteristic curve. Second, the resulting model will be compared with the jails’ suicide identification PAU to assess risk and detection of identified suicide attempts and deaths from intake through 120 days and 13 months after jail release. The funding timeline for this project is August 1, 2022, through July 31, 2025. The algorithm’s predictions and actual event incidence will be linked and validated in the spring of 2025, with results ready for publication in the fall of 2025. Conclusions: The study will also investigate implementation factors, such as feasibility, acceptability, and appropriateness, to optimize jail uptake. Interview data on the implementation factors will be gathered in the summer of 2025, with expected dissemination in 2026. We hypothesize that a combination of intake screening PAU and the ML model will be the optimal approach, in that the combination will be more accurate and can have practical application in this context.

Background: Diabetes prevention programs focus on people with prediabetes because they have a greater risk of developing type 2 diabetes mellitus than people with normal blood glucose levels. Weight management can reduce this risk. However, in our largely sedentary society, there is less enthusiasm for regular exercise. Whole-body electromyostimulation (WB-EMS) is a training technology that provides exercise-like effects by inducing muscle contractions using electrical currents. There is evidence that local EMS can improve glucose metabolism. Several studies investigated the effect of WB-EMS on cardiometabolic risk factors including blood glucose control in a population of individuals with metabolic syndrome. However, to the best of our knowledge, there is no randomized controlled trial examining the preliminary efficacy of WB-EMS on hemoglobin A1c (HbA1c) levels in individuals with prediabetes. Objective: The objective of this randomized controlled trial is to pilot procedures for a randomized controlled trial testing WB-EMS training on glycemic changes in sedentary adults with prediabetes. Methods: A total of 60 community-dwelling sedentary adults aged 40-65 years with prediabetes will be randomized to one of 3 arms: WB-EMS + an activity tracker and a lifestyle education program (LEP) focusing on diabetes prevention, an activity tracker and LEP, or LEP only, with 20 individuals in each arm. The WB-EMS training will consist of 1.5×20 minutes per week. The intervention will last 16 weeks. As a pilot study, our main outcomes concern the number of participants who will be recruited, and comply with intervention and follow-up. The primary efficacy outcome of interest includes hemoglobin A1c. The intention-to-treat analysis will be conducted with the objective of providing CI estimation of treatment effects. Results: The recruitment of study participants started in February 2024. At the time of submission of this protocol for publication, the recruitment was still ongoing. As of October 2024, a total of 42 participants were allocated to the study groups. The anticipated date of recruitment completion is July 2025. Conclusions: The results of this trial will provide valuable evidence for future investigations comparing the efficacy of the WB-EMS intervention with traditional exercise training to improve glycemic control in this population. Trial Registration: ClinicalTrials.gov NCT06188481; https://clinicaltrials.gov/study/NCT06188481

Background: Even before the COVID-19 pandemic, caregivers of children with rare neurogenetic conditions (NGCs) experienced physical and mental health challenges. These challenges escalated during the COVID-19 pandemic due to crisis-level breakdowns in support services. Tele–mental health and parenting support services expanded rapidly in response to the COVID-19 pandemic and may be well suited to facilitate necessary support interventions for NGC caregivers. However, it remains unclear how to match these evidence-based interventions to individual NGC caregivers’ needs. Objective: Project WellCAST (Supporting Well-Being of Caregivers via Telehealth) is an early-phase clinical trial designed to prospectively test which evidence-based telehealth interventions best meet the needs of NGC caregivers. Methods: Interested and eligible NGC caregivers are enrolled in a 24-week program with 5 phases, including baseline (2 weeks), support program (12 weeks), and follow-up (2 weeks) periods; a 4-week gap separates the phases. Caregivers participate in 2 randomizations, namely support program assignment via a precision health algorithm versus quasi-random assignment and motivational coaching by another NGC caregiver and project staff member (“peer coaching”) versus standard check-ins by a staff member who is not an NGC caregiver (“staff coaching”). Virtual support programs include acceptance and commitment therapy, dialectical and behavioral therapy, culturally informed cognitive behavioral therapy, research units in behavioral intervention, naturalistic communication intervention, Durand sleep intervention, and self-guided resources. A subset of caregivers will participate as waitlist controls before engaging in support programs. We developed and optimized a personalized health decision tree algorithm that matches caregivers to telehealth support programs. We then proceeded to test the feasibility and efficacy of algorithm-assigned support programs across 4 waves of data collection, relative to quasi-random assignment and waitlist controls. During each wave, the personalized health algorithm relies on 2 weeks of baseline data collection using clinical tools and innovative smartphone-based ecological momentary assessments. Across waves, we also test the efficacy of a motivational peer-to-peer coaching protocol, deployed by trained NGC caregiver staff, in enhancing support program uptake and clinical outcomes. Results: Four waves of data collection are scheduled for August 2023 to September 2025. Preregistered analyses will contrast feasibility, efficacy, and acceptability across algorithms and coaching assignments. Multiple waves of data collection will allow us to continually optimize the algorithm and test incremental improvements across project phases. Secondary analyses will probe the feasibility and efficacy of individual evidence-based support programs and peer coaching. Conclusions: Project WellCAST will test whether a digital personalized health decision tree algorithm and peer coaching protocol can prospectively enhance telehealth support program outcomes among NGC caregivers. This project is relevant to the specific population of NGC caregivers and may also inform how brief digital assessments, precision health tools, and community-academic partnerships can enhance the public health response to mental health crises across other high-need populations. Trial Registration: ClinicalTrials.gov NCT05999448; https://clinicaltrials.gov/study/NCT05999448 and OSF Registries 10.17605/OSF.IO/8WNDP; https://osf.io/8wndp

Background: Cancer during pregnancy is a rare and significant life-changing event affecting approximately 1 in 1000-2000 pregnancies. With increasing maternal age and broader application of prenatal screening programs such as the Dutch Non-Invasive Prenatal Testing, incidental detection of maternal cancer is becoming more frequent. Advancements in safe treatment options during pregnancy, supported by the International Network on Cancer Infertility and Pregnancy (INCIP), have led to fewer pregnancy terminations. Consequently, more children are exposed to chemotherapy and other cancer treatments in utero. While short-term safety has been demonstrated for many oncological agents, long-term side effects including physical, neuromotor, neurocognitive, and psychosocial impacts on offspring and their families after delivery are still being assessed. Standard settings for surveillance and care of offspring and their families have, however, never been described. Objective: Given the importance of expertise in assessing the long-term outcomes of children, the Netherlands established the national centralized Cancer in Pregnancy (CIP) offspring outpatient clinic in 2018, which functions as a standard-of-care surveillance clinic and contributes data to the INCIP registry. Here we provide a demographic overview of referred families and to share (logistic) experiences with the national, centralized, multidisciplinary, and standardized long-term surveillance program for all Dutch children with in utero exposure to maternal cancer and its treatment. Methods: The CIP offspring outpatient clinic is located at the Princess Máxima Center for Pediatric Oncology and provides surveillance from infancy until 18 years of age. The, relatively small dedicated team, comprising pediatric oncologists, physiotherapists, and a psychological expert, offers a 1-day, multidisciplinary assessment, including physical examinations, neuromotor tests, cardiac monitoring (for anthracycline exposure), renal and auditory screening (for platinum agents), neurocognitive testing, and psychosocial evaluation. Surveillance is aligned with international INCIP guidelines. Results: From May 2018 to 2024, a total of 226 children (from 221 mothers) have been referred to the CIP offspring outpatient clinic, with 465 follow-up visits completed. The most common maternal cancer types were breast, gynecological, and hematological malignancies. Most women (58%) received chemotherapy during pregnancy; 11% of them had surgery only, 3% underwent radiotherapy, 3% underwent immunotherapy, 16% received a combination of treatment modalities, and 8% did not undergo treatment during pregnancy. Anthracyclines were the most commonly used agents. Median gestational age at delivery was 37.3 weeks. Fourteen percent of the mothers died shortly after delivery, underscoring the emotional and logistical challenges for families. Conclusions: The CIP offspring outpatient clinic provides a unique, structured approach to long-term surveillance for in utero–exposed children, which enables early detection of potential late effects and provides comprehensive family support. By sharing knowledge and experiences from the unique setting of this national centralized CIP offspring outpatient clinic, this initiative may inspire other countries in developing similar translational facilities to support affected families and improve care worldwide.

Background: Assessing the competencies of health profession educators presents significant challenges, leading to the suggestion of implementing Entrustable Professional Activities (EPAs) as a potential solution. EPAs refer to the authority granted to individuals to perform tasks with a specified level of trust and competence. The concept of EPAs emerged from the complexities of competency-based medical education. This scoping review highlights the emerging yet underdeveloped field of EPAs for dental educators. Despite their established utility in medical education, the concept remains relatively novel for dental educators, with limited literature and inconsistent application across studies. Objective: This paper presents a scoping review protocol aimed at systematically elucidating the extent, range, and nature of the literature on EPAs for dental educators, as evaluated in the included resources. This review seeks to answer the following research question: what are the key functional elements of EPAs for dental educators as described in the existing literature? Methods: This scoping review will be conducted in accordance with the framework outlined by Arksey and O’Malley, enhanced by the Joanna Briggs Institute (JBI) guidelines. The literature search will use a 3-step strategy across 5 electronic databases (PubMed, Google Scholar, Scopus, Cochrane Library, and ProQuest), along with additional screening of gray literature. Primary data from relevant studies published from the introduction of EPAs in 2005 through 2024 will be analyzed. This review will include peer-reviewed literature focused on EPAs, specifically those involving dental educators in undergraduate, postgraduate, or continuing education contexts. Studies of any design (qualitative, quantitative, or mixed methods), as well as conceptual papers and reviews, will be considered. Only English-language studies will be included. The literature search process will involve a librarian, while study selection and evidence charting will be conducted by 4 independent reviewers. These reviewers will independently screen titles, abstracts, and full texts against the inclusion criteria. Data will be charted using a standardized extraction form and analyzed thematically. Results: Findings will be presented in both tabular and narrative formats, highlighting the range, characteristics, and key components of EPAs relevant to dental educators. In addition, these findings will be mapped to the competencies of dental educators. This review is estimated to be completed within 6 months and aims to identify gaps for future research, ultimately supporting the advancement of competency-based dental education. The results of this review will serve as a foundation for a larger study focused on developing a framework of EPAs specifically tailored for dental educators. Conclusions: The identification of EPAs and their themes provides an initial framework that can guide the development of more structured, competency-based academic roles for dental educators. A tailored EPA framework holds promise not only for clarifying faculty expectations and enhancing performance assessment but also for supporting faculty development. Trial Registration:

Background: The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies; however, their results are not consistent. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac contractility with the arterial system would provide a more comprehensive understanding of cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradient distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome in patients undergoing HD. Recently, a noninvasive method for assessing left ventricular pressure-volume loop and ventriculo-arterial coupling (VAC) from feature-tracking cardiac magnetic resonance or echocardiography has been proposed. We believe that this method allows a comprehensive evaluation of the hemodynamic status of the patients undergoing HD, including the relationships between cardiac function and arterial elastance, and might provide prognostic information. Objective: The primary objective of this study is to evaluate changes in VAC before and after a HD session. The secondary objective is to assess the prognostic value of VAC parameters in predicting adverse outcomes. Methods: A 2D transthoracic echocardiogram will be performed before and after a HD session in patients with end-stage renal disease. We target to enroll 323 patients. Images will be analyzed with advanced software based on speckle-tracking, able to reconstruct the pressure-volume loop. From the pressure-volume loop, arterial (Ea) and ventricular (Ees) elastance will be derived. VAC will be calculated as the Ea/Ees ratio. Patients will be followed up for 18 months. Primary endpoints will be a composite of all causes of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure. Results: The study received funding in August 2024, with patients’ enrollment scheduled to take place from January 1 to June 30, 2025. Data analysis will start in April 2025 and is expected to continue until June 2026. The findings of the study are tentatively planned for publication in the winter of 2027. Conclusions: This study will provide data on the changes in VAC induced by HD and their potential prognostic value. This assessment could be useful for tailoring volume depletion during HD and to improve patients’ outcomes. Trial Registration: ClinicalTrials.gov NCT06622928; https://clinicaltrials.gov/study/NCT06622928

Background: Valganciclovir (VGCV) is the first-line drug for preemptive therapy of cytomegalovirus (CMV) infections. However, even when administered at the dose specified in the package insert, there is significant interindividual variability in the plasma concentrations of ganciclovir (GCV). In addition, correlations have been reported between the area under the concentration–time curve and therapeutic efficacy or adverse events. Therefore, therapeutic drug monitoring (TDM) can be used to improve the efficacy and safety of preemptive VGCV therapy. Objective: This study aims to evaluate whether the dosage adjustment of VGCV based on TDM in patients undergoing preemptive therapy for CMV infections is associated with the successful completion rate of treatment without severe hematological adverse effects. Methods: This phase II, single-center, single-arm trial aims to enroll 40 patients admitted at the Department of Rheumatology and Clinical Immunology, Kobe University Hospital, who will receive oral VGCV as preemptive therapy for CMV infections. Participants will begin treatment with VGCV at the dose recommended in the package insert, with subsequent dose adjustments based on weekly TDM results. The primary end point will be the proportion of patients who achieve CMV antigenemia negativity within 3 weeks without severe hematological adverse events. The secondary end points will include weekly changes in CMV antigen levels, total VGCV dose, and duration of preemptive therapy. For safety evaluation, the occurrence, type, and severity of VGCV-related adverse events will be analyzed. Additionally, this study will explore the correlations between the efficacy and safety of preemptive therapy and the pharmacokinetic parameters of GCV, CMV-polymerase chain reaction values, and nudix hydrolase 15 (NUDT15) genetic polymorphisms. The correlation between GCV plasma concentrations obtained from regular venous blood and blood concentrations will be examined using dried blood spots. Results: This study began with patient recruitment in September 2024, with 5 participants enrolled as of June 16, 2025. The target enrollment is 40 participants, and the anticipated study completion is set for July 2027. Conclusions: This is the first study to investigate the impact of TDM intervention in patients receiving VGCV as preemptive therapy. The findings are postulated to provide valuable evidence regarding the utility of TDM in patients receiving VGCV as preemptive therapy. Trial Registration: Japan Registry of Clinical Trials jRCTs051240080; https://jrct.mhlw.go.jp/latest-detail/jRCTs051240080

Background: Metabolic syndrome (MetS) is a growing concern among adult populations in India, particularly among those living in urban, low-income settings. This group is challenged by a combination of risk factors, including an urbanized lifestyle, poor access to health care, and financial limitations, leading to high levels of obesity, diabetes, and hypertension. Objective: This study aims to address this challenge by designing, developing, and piloting a tailored, mobile-enabled, interactive, digital health intervention to enhance self-management of MetS among individuals living in urban, low-income settings in New Delhi, India. Methods: The study uses mixed methods, including both quantitative and qualitative data collection, to design and evaluate the effectiveness of the intervention built on a multifactorial model in improving the self-management of MetS. Data will be collected at baseline and 12 months from adults living in urban, low-income settings in New Delhi. The results will contribute to our understanding of the interplay of risk factors in MetS and the impact of tailored digital health interventions in addressing this challenge. The findings will be disseminated to both national and international audiences through peer-reviewed publications. Results: This study was funded in March 2022 for 3 years. The project started in April 2022. Data collection began in June 2022. The results are expected to be published in 2025. Conclusions: The study is expected to provide valuable insights into the role of digital health interventions in enhancing the self-management of MetS among urban, low-income populations.

Background: The rising prevalence of mental health concerns among students is prompting universities to explore innovative solutions to support student well-being. This paper describes the protocol for the development, implementation, and evaluation of a mobile app designed to address the mental health and wellness needs of students. This project employs a student-centered approach, partnering with students from the initial needs analysis through to the final design and implementation stages. Objective: The app aims to increase the use of campus resources that address student mental health and wellness by improving the awareness of these resources through user-designated preferences that are established on the initial use of the app and then iteratively refined as it is used. The app is linked to the campus student’s electronic health record so that health and wellness services can be coordinated and enhanced and the student journey to and through care become more seamless. The long-term objective is to leverage data from both the app and electronic health record to improve individual and population health for the entire campus. Methods: At the beginning of the project, a comprehensive logic model was created to outline the core inputs, activities, outputs, outcomes, and long-term impacts that were desired for the app. The model emphasized the integration of the app within existing campus mental health and wellness services and its potential to foster a culture of well-being across the university community. An evaluation plan was developed that incorporates both quantitative and qualitative methods through biannual assessments to track trends and app impact across campus in addition to feasibility, acceptability, and usability as well as its reach, effectiveness, and sustainability. Validated measures such as the Patient Health Questionnaire and Generalized Anxiety Disorder scale were selected to track changes in mental health and wellness, while custom surveys and analytics will gauge user engagement and satisfaction. New students, including freshmen, transfers, and first-year medical students, are invited to participate after giving informed consent. They receive compensation for their involvement in both quantitative and qualitative assessments. Results: As of March 2025, we have collected over 600 survey responses from freshmen, transfer, and medical students. A second survey round and additional focus groups are planned for April to May 2025. No analyses have been conducted yet. The findings from this project have the potential to inform similar efforts at other institutions and contribute to the broader field of digital mental health innovation and the development of well-being interventions tailored for young people. Conclusions: By leveraging digital technology and actively engaging students in supporting their well-being, this initiative represents an innovative user-centered approach to improve mental health and wellness support on university campuses.

Background: There has been controversy over the extent to which technology use in general—and social media exposure specifically—may be associated with adverse youth mental health outcomes. To date, studies have generally been small and exploratory, relying on youth self-reports to characterize technology and social media use patterns. The goal of this study is to explore the associations between objectively collected data, gathered through a commercially available app, and youth mental health outcomes. Objective: The broad goal of this study is to characterize the association between objectively measured technology/social media use and a range of mental health–related outcomes. Three specific aims will be initially addressed. First, we aim to quantify the association between objectively measured smartphone use and measures of well-being. Second, we aim to differentiate types of engagement—specifically, the types of content consumed versus the overall time spent on the device—and examine their association with outcomes. Third, we aim to identify moderating factors, such as age, gender, and socioeconomic status, that might influence these relationships. A secondary broad objective of this research is to establish a freely available data resource that can be accessed by qualified investigators to address a much wider range of questions in the future. Methods: Up to 1000 male, female, and nonbinary youth aged 8-17 years (inclusive), along with their primary caregivers, will be enrolled in the study. Youth participants must have their own dedicated iOS- or Android-based smartphone or tablet, and both they and their parents must be willing and able to download and install the data collection app on their devices. The study is open to all US-based participants who meet these 2 criteria. Following electronic consent (eConsent), participants and their caregivers will complete a range of baseline measures electronically, including assessments of psychiatric and social functioning, as well as measures of loneliness, digital stress, and disordered eating. Caregivers will be asked to provide information on the participant’s health and mental health history. Youth and caregivers will then complete a similar battery of assessments 1, 2, and 3 months after baseline. Youth participants will also respond to daily questions about their mood, stress, physical activity, and sleep. Both youth and their caregivers will be compensated for completing measures at each time point. The data collection app gathers a wide range of daily data from the participant’s device, including temporal patterns of use, the number and frequency of various app usage, social interactions within apps, and keystroke data. A variety of analytic methods will be used to address key questions related to how technology and social media use are associated with mental health and wellness outcomes. Results: Enrollment for this study began on November 13, 2024. As of May 20, 2025, a total of 106 participants and their caregivers had consented to participate and provided baseline data. An additional 203 children and parents have consented and are currently undergoing eligibility verification and enrollment. Initial data analysis is anticipated to begin in late autumn 2025 or winter 2026, with the expected publication of initial findings in spring 2026. Conclusions: This study will be among the largest to date to collect both objective device usage data and validated, clinically relevant outcome measures. In accordance with our data-sharing policies, any qualified investigator will be able to access the study data, provided appropriate steps are followed. Trial Registration: ClinicalTrials.gov NCT06664944; https://clinicaltrials.gov/ct2/show/NCT06664944

Background: Physical activity (PA) has significant health benefits for older adults. However, many older adults in Hong Kong remain physically inactive. Interventions tailored to one’s current stage of change (SOC) are more effective than non-SOC-tailored ones in facilitating behavioral changes. Chatbots are potentially useful to deliver SOC-tailored interventions to promote PA among older adults. Objective: This randomized controlled trial (RCT) will compare the efficacy of an SOC- versus a non-SOC-tailored intervention in increasing the prevalence of meeting World Health Organization (WHO)-recommended PA levels 6 months after completion of the intervention among inactive community-dwelling individuals aged ≥65 years. Methods: This is a partially blinded (outcome assessors and data analysts) and parallel-group RCT. A total of 278 inactive community-dwelling people aged 65 years or more will be randomized evenly into either an intervention group or a control group. In the intervention group, a fully automated chatbot with natural language processing (NLP) functions will measure participants’ SOC related to PA and deliver web-based interventions tailored to their current SOC every week for 12 weeks. In the control group, the chatbot will not measure participants’ SOC but will deliver a non-SOC-tailored web-based intervention every week for 12 weeks. Participants will be interviewed at baseline (T0), after completion of the intervention (T1), and 6 months after T1 (T2). The primary outcome is the prevalence of meeting WHO-recommended PA levels (ie, at least 150 minutes of moderate-intensity aerobic PA, at least 75 minutes of vigorous-intensity aerobic PA, or an equivalent combination of moderate-to-vigorous physical activity [MVPA] every week). PA will be measured using the Chinese version of the International Physical Activity Questionnaire Short Form (IPAQ-SF) and accelerometers at T0, T1, and T2. Secondary outcomes include (1) minutes of MPVA, low-intensity PA, and sedentary time in the past week; (2) step counts in the past week; (3) SOC levels, perceived pros, perceived cons, and perceived self-efficacy related to PA; (4) compliance to the web-based interventions; and (5) cognitive status measured at T0, T1, and T2. Intention-to-treat analysis will be used for data analysis. Results: Recruitment started in November 2024. By February 2025, a total of 185 participants completed the baseline assessment and were randomly assigned to either the intervention group (n=93, 50.3%) or the control group (n=92, 49.7%). Recruitment will be completed by the end of June 2025. The follow-up assessment at T1 started in March 2025. Data collection is expected to be concluded in February 2026. Conclusions: The findings will extend the application of SOC and contribute to the evidence of the effectiveness of SOC-tailored and chatbot-delivered interventions. If the chatbot-delivered SOC-tailored intervention is proven effective to increase PA levels, it will require relative less resources to implement and maintain. It can be integrated into the existing WhatsApp groups operated by organizations providing services to older adults in Hong Kong and create public health impacts. Trial Registration: ClinicalTrial.gov: NCT06641492; https://clinicaltrials.gov/study/NCT06641492

Background: Given the high rates of HIV infection among young Black men who have sex with men in Jackson, Mississippi, and the underuse of pre-exposure prophylaxis (PrEP) in this population, there is a critical need for innovative interventions to promote PrEP use. Acceptance and commitment therapy (ACT) is a promising intervention for health behavior change. Objective: This study aims to develop and test an intervention, ACTPrEP, to increase PrEP use among young Black men who have sex with men. Methods: We conducted in-depth interviews with 20 young Black men who have sex with men and 10 PrEP staff to inform the development of ACTPrEP, an intervention that uses ACT to improve PrEP use. Specific ACTPrEP adaptations from the qualitative interviews included service settings (interventionists should be PrEP informed and well-integrated), target audiences (provide check-in calls, be caring, and authentically relate), modes of delivery (flexible delivery), and cultural adaptation (normalize PrEP use). A pilot randomized controlled trial will evaluate the feasibility and acceptability of ACTPrEP compared to that of Enhanced Standard of Care in promoting PrEP use among young Black men who have sex with men (N=66). We will specifically evaluate group differences in the proportion of participants who initiate PrEP, PrEP adherence, and PrEP persistence. Measures will be collected at baseline, 6 weeks, and 12 weeks. Results: Research activities began in September 2023 and will be ongoing through June 2026. Preliminary findings are anticipated to be available in late 2026. Conclusions: This study will inform the development of a larger randomized controlled trial to evaluate the efficacy of ACTPrEP for increasing PrEP use among young Black men who have sex with men. Trial Registration: ClinicalTrials.gov NCT05087680; https://clinicaltrials.gov/study/NCT05087680

Background: Preexposure prophylaxis (PrEP) remains one of the most efficacious interventions for preventing HIV, but its effectiveness is often limited by poor persistence. Although regional efforts have primarily focused on young women and men who have sex with men, heterosexual men in East and Southern Africa represent a crucial group to engage and retain in PrEP care—both to improve health outcomes for men and to interrupt HIV transmission chains. Men seeking sexually transmitted infection (STI) services are particularly vulnerable to HIV acquisition, yet only a few interventions have tested strategies for engaging and retaining these men in PrEP services. Systems navigation, which addresses barriers to health care access and enhances comfort in clinical settings, may offer a promising approach to improving persistent PrEP use among heterosexual men. Objective: This study will assess the effect of a peer-delivered systems navigator–facilitated HIV prevention package on PrEP persistence at 26 weeks among heterosexual men seeking STI clinical services in Lilongwe, Malawi. It will also evaluate the acceptability of the intervention and barriers to implementation among key stakeholders. Insights will inform the feasibility of a future randomized controlled trial. Methods: In this single-site pilot type I effectiveness-implementation hybrid randomized controlled trial, 200 heterosexual men seeking STI services and initiated on PrEP in Lilongwe, Malawi, will be randomized (1:2) to standard-of-care PrEP services or systems navigator–assisted PrEP care (intervention). Participants will be followed every 13 weeks for at least 26 and up to 52 weeks. PrEP use and engagement in care will be assessed through medical record review and intraerythrocytic tenofovir diphosphate measurement, using objective biomedical analyses via dried blood spot. Primary effectiveness and implementation outcomes include 26-week PrEP persistence (adapted to accommodate daily oral, event-driven oral, or injectable PrEP) and acceptability, respectively. Additional implementation outcomes include feasibility and cost. Exploratory objectives characterize preferences for PrEP modalities, perceived and experienced stigma, and the influence of gender norms on PrEP persistence. All clinical services, including the provision of PrEP and PrEP safety monitoring, are being conducted by the Malawi Ministry of Health. Results: HPTN (HIV Prevention Trials Network) 112 was funded in November 2023. Study recruitment began in April 2024 and closed in November 2024. As of February 3, 2025, the study has enrolled 199 participants, with follow-up expected through June 2025. No interim analyses were planned; data analysis for primary end points is expected in the summer of 2025. Conclusions: Improving PrEP use outcomes among heterosexual men in East and Southern Africa is critical to interrupting HIV transmission. This study offers unique insights into a low-resource, potentially scalable intervention, focusing on a group of men at particularly high risk of HIV acquisition—those with recent STIs. The hybrid RCT design addresses clinically relevant effectiveness questions and explores key determinants that will inform future multisite implementation trials. Trial Registration: ClinicalTrials.gov NCT06200545; https://clinicaltrials.gov/study/NCT06200545

Background: Average sugar consumption among young children in the United Kingdom exceeds the recommended intake. Many parents choose commercial baby foods believing these to be a healthy option. However, surveys show many products contain high levels of added or free sugars, despite labeling suggesting they are “natural” and “healthy.” Analysis of labels and studies with parents suggest changes such as removing misleading marketing or adding sugar warning labels may impact parents’ beliefs and food choices. However, the literature does not provide a comprehensive understanding of the range of changes to commercial baby food labels that might best support parents in choosing healthier foods for their children. Objective: This scoping review will explore the published and unpublished evidence base to better understand what is known about how labeling of baby foods impacts parents’ beliefs about a product’s sugar content and related purchasing and feeding decisions. Methods: The JBI guidelines for methodology of scoping reviews will be followed, and results will be reported using PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) guidelines. The population, concept, and context (PCC) framework will be used to determine eligibility criteria. The search will include various research methodologies, including both quantitative (observational and interventional) and qualitative studies. An initial search of MEDLINE (Ovid) and Embase (Ovid) was conducted to develop a full search strategy for MEDLINE, which is presented here. In addition to MEDLINE and Embase, we will search PsycINFO (Ovid), CINAHL (Ebsco), Web of Science (Core Collection) and the Cochrane Library. Reference lists of included studies will also be searched. Unpublished reports will be identified using Google, Google Scholar, relevant websites, policy statements, and government reports and by contacting relevant government and third-sector organizations. In a 2-stage process, 2 reviewers will independently screen titles and abstracts and then full texts. One reviewer will then extract data and a second will verify accuracy. Findings will be presented in tables and diagrams accompanied by a narrative summary. Results: The literature searches yielded 2071 records from 6 databases, with 1123 documents remaining after deduplication. The gray literature search used a customized Google search, a targeted search of 34 websites, and contact with 49 experts. Conclusions: We present a protocol for a scoping review to explore the evidence base to understand what is known about how the labeling of baby foods impacts parents’ beliefs about sugar content and related purchasing and feeding decisions. The results of the review will help policymakers better understand regulatory opportunities to improve the labeling of commercial infant foods to help families feed infants and young children lower-sugar diets.

Background: Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music therapy in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. Objective: The aim of this study is to determine the effect of live Environmental Music Therapy and prerecorded music on state anxiety, stress, pain, and well-being levels in patients and caregivers in the emergency unit waiting areas of 2 hospitals in Colombia. Methods: This study is a multicenter randomized clinical trial, with 3 arms: standard care + live Environmental Music Therapy, standard care + prerecorded music, and standard care only. The primary outcome measure is the 6-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention. A total of 246 patients (82 in each arm) and 147 caregivers (49 in each arm) will be randomized. Results: Data collection for this study started on September 3, 2024, and as of the submission of the study (November 2024), 216 patients and 134 caregivers have been enrolled. It is expected that the results will be available by May 2025. Conclusions: This study seeks to contribute to improving the mental health, well-being, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect of live music therapy and prerecorded music interventions in the emergency department. Trial Registration: ClinicalTrials.gov NCT06510153; https://clinicaltrials.gov/study/NCT06510153

Background: Current gold standard chronic pain management applies a biopsychosocial lens to clinical care, integrating medication, psychosocial support, and physical reconditioning to promote sustained treatment success, increase quality of life, and control symptoms. However, only 40% of patients with chronic pain report adequate pain management. Unfortunately, evidence describing implemented treatment pathways or models of care (MoCs) that consistently use this holistic approach is lacking. Objective: The aim of this study is to identify the barriers and facilitators to access and engagement in existing MoCs for chronic pain, explore aspects of the delivery of care that can be improved, and develop an improved MoC for pain clinics in New South Wales by directly liaising with people with chronic pain and their families. Methods: A 2-phase qualitative study will be conducted using semistructured focus groups. Both phases will follow the same structure, so patients, carers, and clinicians will independently provide input into the proposed MoC, which will then be summarized and integrated by the research team. Participants will be encouraged to interact and speak freely across three core domains: (1) experience of chronic pain management, (2) barriers and facilitators to delivering/accessing a gold standard MoC, and (3) key improvement points to existing models. Each focus group will last 90 minutes and be audio-recorded and transcribed verbatim for qualitative analysis. The focus groups in phase one will generate initial recommendations for primary changes to the existing MoC, and these will then be integrated and presented for evaluation, feasibility, and acceptability by stakeholder groups during phase two. Results: Data collection commenced in September 2023 and is expected to end by September 2025. As of February 2024, we have completed the focus group with clinicians (n=12) and patients (n=7) in phase one. Data have not been analyzed formally and will be reported in a future publication. Conclusions: Through the exploration of key stakeholders’ perspectives of the barriers preventing access and the delivery of care in the current MoC for chronic pain, we aim to co-design an appropriate, feasible, and acceptable pathway to be implemented in pain services in the future.

Background: With a predicted 2 million new cases identified globally in 2018, breast carcinomas are the most common cancer in women and the primary cause of cancer-associated mortality. In the management of breast cancer, neoadjuvant chemotherapy treatment (NACT) has become a mainstay, particularly for patients with inflammatory and locally advanced breast cancer. It increases the possibility of breast-conserving surgery, facilitates tumor downstaging, and gives early indications of the effectiveness of treatment. Evaluating the histopathological response after NACT is crucial for prognosis and guiding subsequent treatment decisions. This study explores the various histopathological assessment systems used in breast carcinoma patients after NACT, focusing on the residual cancer burden (RCB) score, Miller-Payne system, Chevallier classification, Sataloff classification, National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 system, and the American Joint Committee on Cancer residual tumor size (R) categories. We compare their methodologies, strengths, limitations, and clinical significance, providing a detailed analysis of their roles in improving patient outcomes. Objective: The aim of this study is to confirm the diagnosis of breast carcinoma based on histopathology, to evaluate various scoring systems through assessments of histomorphological features affecting post-NACT patients with breast carcinoma, to compare the various systems regarding the response to therapy and forming prognoses, and to develop an ideal histomorphological assessment system for breast carcinoma in post-NACT patients. The study also focused on how breast tumors respond to NACT and how this response can guide treatment decisions and improve the formulation of prognoses. Methods: This observational study will be retrospective and prospective; it will include 128 patients diagnosed with breast carcinomas who have undergone NACT and were referred to a tertiary care hospital between January 2019 and December 2024. Following chemotherapy, a thorough examination of the histopathological specimens will be conducted to assess any changes in histomorphology. Results: Data collection started in September 2021 and will be completed by December 2025. Data analysis began in January 2025, and the results are expected to be published in December 2025. Institutional ethics committee clearance was obtained prior to commencement of the study. This is a nonfunded academic study. Conclusions: This project aims to evaluate and compare histopathological assessment systems in patients with breast carcinoma after NACT. Various histopathological systems, such as the RCB score, the Miller-Payne grading system, and other systems, each provide valuable insights into how well tumors respond to chemotherapy. The aim is to reveal essential histopathological parameters, leading to the refinement and potential modification of grading systems to improve clinical decision-making, treatment outcomes, and personalized care; however, challenges persist in standardization and consensus.

Background: Occupational stress is associated with detrimental consequences that are addressed by mobile health (mHealth) solutions. Previous developments of apps for occupational stress have not yet fully exploited the potential of multilevel diagnostics through the integration of wearable sensors for interventions. Personalizing mHealth approaches in terms of intervention time and content, which requires the use of artificial intelligence, is the next logical developmental step. The "Relax" approach developed a corresponding prototype of an app-wearable system, which will be evaluated for effectiveness in terms of stress reduction and usability. Objective: This study protocol describes an evaluation study used to test the effectiveness and usability of the Relax approach. Methods: The evaluation study was designed as a 2-arm randomized trial with 2 phases, each with a 3-week intervention period. In both phases, employees were required to use the app to record daily stress and to wear a wearable sensor to measure heart rate variability. The app offered interventions based on algorithms, which altered the probability of their selection after learning from the data, thereby personalizing the user experience. In the second phase of the study, the sample was divided into 2 groups, varying the degree of personalization of the app. To analyze effectiveness, a 2-factorial mixed within-between design will be applied to compare the outcomes between both groups as well as in a pre-post comparison. In addition, exploratory analyses of the usability of the approach are planned. Results: The study was conducted during the spring and summer of 2024, with a total of 46 participants enrolled, and is ready for data analysis. Conclusions: The Relax approach, including a number of factors related to personalization that have not yet been incorporated into mHealth in current research, will provide new insights into the next steps of advanced mHealth solutions. Limitations of the study design, such as the lack of a control group and the sample representativity, have to be addressed. Clinical Trial: Open Science Foundation 10.17605/OSF.IO/MYRD9; https://osf.io/myrd9

Background: The aging of the population is a major issue in Canada, particularly in Quebec. For people older than the age of 65 years, aging is often associated with both mild and severe cognitive impairment. The management of these disorders increases the pressure on health care systems. Digital health technologies could be used to promote the cognitive health of older people living with cognitive disorders. However, to reap the full benefits of using digital health technologies, it is critical that older people with cognitive disorders engage with these technologies. A dose-response relationship has been demonstrated between the level of engagement with digital health technologies and the effectiveness of interventions in older people. It is thus important to understand how older people with cognitive impairment engage with digital health technologies and how this engagement can influence the success of digital health interventions. Objective: This study aims to describe how the engagement of older adults with cognitive impairment with digital health technologies is conceptualized and assessed, and how this engagement relates to the effectiveness of digital health interventions. Methods: We will use the scoping review method outlined by Arksey and O’Malley. We will apply a systematic approach following the Joanna Briggs Institute guidelines and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews) checklist to ensure reproducibility of the scoping review. A search strategy, created with a medical information specialist, will be applied to MEDLINE, Embase, CINAHL, Web of Science, and Google Scholar, without time restrictions. Two reviewers will independently select titles, abstracts, and full texts. Data extraction will be conducted by the research team and validated by a senior member, resolving disagreements by consensus or a third party if necessary. Descriptive analyses will be done using concept mapping for a narrative synthesis of the results by themes related to the research questions. Results: The development of the search strategy and the completion of the selection phases of the review were completed in July 2024. Data extraction and analysis began in August 2024, and results are expected to be available in November 2024. Conclusions: The results of this scoping review will provide a comprehensive overview of the different conceptualizations of engagement with digital health technologies in older people with cognitive impairment, as well as the tools to measure it. This will contribute to a better understanding of the relationships between levels of engagement and the effectiveness of digital health interventions in older people living with neurocognitive disorders.

Background: Prenatal anxiety affects between 20% and 30% of pregnant people and is associated with adverse prenatal health conditions, birth outcomes, and postpartum mental health challenges. Individuals from racial and ethnic minority groups, sexual and gender minority groups, and those with low income are all at heightened risk for prenatal anxiety due to disproportionate exposure to adverse social determinants of health. Digital cognitive behavioral therapy (dCBT) has been shown to reliably reduce anxiety in mostly White and middle- to higher-income samples, but its efficacy in low-income and marginalized pregnant people is understudied. Objective: We propose a randomized controlled trial of a dCBT (Daylight app, Big Health, Ltd) in a sample of low-income pregnant people oversampled for racial, ethnic, sexual, and gender minority identity. Methods: Participants (N=132) will be randomized to the intervention or waitlist control group using a 1:1 allocation ratio. The intervention will be a self-guided application that uses an online therapist to teach and encourage the practice of 4 key cognitive behavioral therapy skills (eg, identifying catastrophic thinking and increasing physical relaxation) that can reduce anxiety. The primary outcome will be generalized anxiety symptoms; secondary outcomes will include depressive symptoms, stress, pregnancy-specific anxiety, and insomnia symptoms. Focus groups with a subset of participants will provide qualitative data about the acceptability of dCBT. Results: Recruitment began in June 2024. Data will be analyzed using linear mixed models, which will be fit with treatment condition (dCBT and waitlist control group) as the between-group factor, time (baseline, 3, 6, and 10 weeks post randomization) as a within-group factor, and a group-by-time interaction. Linear mixed models produce unbiased parameter estimates in situations where there are different numbers of observations per record and will accommodate intent-to-treat and sensitivity analyses. Conclusions: This clinical trial will evaluate the efficacy and acceptability of a self-guided dCBT for prenatal anxiety among low-income and marginalized pregnant people, a group that continues to experience substantial barriers to accessing in-person evidence-based psychotherapy. Clinical Trial: ClinicalTrials.gov NCT06404450; https://clinicaltrials.gov/study/NCT06404450

Background: Asthma affects 1 in every 12 persons in the United States, resulting in 1.9 million emergency department (ED) visits annually. However, the lack of patient-reported outcome measures (PROMs) validated for use in the ED limits the evaluation of interventions to improve ED asthma care. Objective: To address this knowledge gap, this study protocol will (1) develop and test the validity and reliability of the Patient Reported Outcomes for Acute Asthma Care and Treatment instrument (PROAACT), (2) test whether receiving more guideline-concordant ED care is associated with improved PROAACT responses, and (3) evaluate the association between PROAACT score and subsequent ED revisits and hospitalizations. Methods: This is a prospective cohort study of adult patients visiting the ED for acute asthma exacerbation across 3 EDs at an urban, tertiary care health system. Eligible patients are 18 years or older, have a prior diagnosis of asthma (self-reported or documented in the electronic health record), are English-speaking, and experiencing an ED visit for asthma exacerbation as determined by the treating clinician. Enrolled participants complete an initial PROM survey during their ED visit assessing their symptoms in the preceding 7 days, then complete a follow-up survey 7 days after ED discharge assessing changes in the symptoms in the subsequent 7 days. To test whether guideline-concordant care is associated with improved PROAACT scores, we will conduct a retrospective chart review of medications ordered during the ED visit, and then compare guideline adherence to changes in PROAACT scores. To test whether improved PROAACT scores are associated with fewer return ED visits and hospitalizations, we will extract all-cause ED visits and hospitalizations within 30 days from a regional health information exchange, and then compare usage to changes in PROAACT scores. We will use item response theory to develop scale responses based on summed item responses, which will allow us to test associations with clinical outcomes, including adherence to guideline-recommended care and return ED visits and hospitalizations. Results: Recruitment is ongoing and has experienced numerous challenges related to the COVID-19 pandemic. To date, we have enrolled over 250 participants and have completed over 200 follow-ups. Recruitment is expected to conclude in spring 2025. Conclusions: Our study is intended to validate the use of PROMs during ED visits for acute asthma exacerbation among adult patients. Completion of the proposed aims will result in one of the first PROMs intended for use among adult ED patients and support the feasibility of collecting PROMs in the ED setting. Trial Registration: Clinical Trials.gov NCT04349020; https://clinicaltrials.gov/study/NCT04349020

Background: Rumination is a transdiagnostic process present in several psychological disorders, involving repetitive negative thinking that individuals may perceive as difficult to control. While the roles of numerous mechanisms underlying rumination have been supported, experiential avoidance (EA) still lacks empirical backing, despite a strong theoretical foundation, partly due to difficulties in examining EA in an ecologically valid context. One promising approach to addressing this challenge is through reducing EA using mobile health (mHealth) and ecological momentary intervention (EMI), and assessing any subsequent decrease in rumination’s deleterious outcomes. Objective: This paper outlines the protocol for a randomized controlled trial using a novel mHealth EMI to address EA in the context of rumination. The app was developed by a multidisciplinary team, incorporating feedback from potential end users. Methods: Consenting individuals (target N=60) who meet the inclusion criteria (self-reporting problems with repetitive negative thinking) will be randomly assigned to 1 of 4 conditions: (1) intervention with therapist support and daily sampling, (2) intervention without support and with daily sampling, (3) partial intervention (emotion validation EMI only) with daily sampling, or (4) control (daily sampling only). The intervention consists of a series of modules delivered over 4 weeks, with assessments conducted before and after intervention, and again at 1-month follow-up (plus an additional 3-month follow-up for intervention participants). Data will be collected both through online self-report assessments and via the app itself. The potential of the EMI to modify the maladaptive feature of repetitive negative thinking will be assessed using mixed-design ANOVA, while the links between avoidance-mood and rumination-mood, in terms of the moderating effect of trial condition, will be evaluated using multilevel models. These will be assessed as primary outcomes. Secondary outcomes are the effects of a supporting therapist on postintervention outcomes in the intervention groups, and time spent using the app as a measure of engagement (analyzed using the mixed-design analysis of covariance). Compliance will be defined as completing both of the first 2 weeks of intervention content in full, and 5 out of the 6 exercises from weeks 3 and 4. Additionally, the study will control for both the amount of time spent in the app and the length of responses to open-ended questions. Results: Recruitment and enrollment for the trial are expected to begin in May 2025 and be completed by July 2025. Data collection will conclude once the target sample size for each of the 4 conditions has been reached. The main results of the trial are expected to be submitted for publication in October 2025. Conclusions: The outcomes of this research trial will not only provide insights into the clinical capabilities of the app, including its usability and acceptability in real-world contexts (and its potential future viability as a scalable product), but will also offer valuable theoretical insights into the role of EA in maladaptive rumination. Trial Registration: ClinicalTrials.gov NCT06570694; https://clinicaltrials.gov/ct2/show/NCT06570694

Background: Pain experienced during childbirth can significantly impact the progress of labor and the well-being of both the mother and the fetus. Effective management of labor pain is a crucial component of childbirth care. Nonpharmacological methods of pain relief offer notable advantages over pharmacological approaches, including enhanced maternal and fetal safety, equitable access to health care, and greater availability. Among the nonpharmacological options, transcutaneous electrical nerve stimulation (TENS) and acupoint stimulation are two commonly used methods for alleviating pain during labor. However, the clinical efficacy of these methods remains inconsistent, which hinders the generation of high-quality evidence for clinical practice. Objective: This study aims to assess the effects of acupoint stimulation combined with TENS on labor pain, delivery outcomes, and childbirth experience for women undergoing a trial of labor. Methods: This is a 12-month stepped wedge cluster randomized trial to be conducted in 4 labor and delivery units (LDUs) at the Obstetrics and Gynecology Hospital of Fudan University. Each unit will implement 4 types of interventions: TENS, acupoint stimulation, TENS combined with acupoint stimulation, and a control group. We aim to recruit approximately 588 pregnant women. The project will be evaluated using both quantitative and qualitative data. Quantitative data will include visual analog scale (VAS) scores, the nonpharmacological to pharmacological pain management interval (NPI), the rate of epidural analgesia, and childbirth outcomes. Qualitative data will include interviews with the women and midwives. Results: The study commenced on April 1, 2023, and as of March 29, 2024, a total of 600 eligible participants have been enrolled, surpassing the initial target of 588. Data collection has been completed, including quantitative assessments of labor pain intensity, analgesic use, and childbirth outcomes, alongside qualitative interviews with participating women. Currently, data analysis is in progress, with preliminary findings anticipated to be available by March 2025. We hypothesize that TENS combined with acupoint stimulation will demonstrate greater efficacy in managing labor pain compared with standard care. This effect may be observed in key outcome measures, including the VAS score and enhanced maternal childbirth experience. Conclusions: This study protocol details the interventions of acupoint stimulation and TENS for women undergoing a trial of labor. We introduce a novel outcome indicator termed NPI, which monitors whether the application of nonpharmacological pain relief measures can delay or prevent the use of epidural analgesia. The integration of qualitative and quantitative methods will enrich the research on TENS and acupoint stimulation technology within the realm of nonpharmacological labor pain relief, providing high-quality evidence for the future establishment of industry standards and guidelines. Trial Registration: Chinese Clinical Trial Registry ChiCTR2300069705; https://tinyurl.com/2s3mkhr7

Background: Young people living with HIV face challenges in consistently adhering to antiretroviral therapy (ART). Although mobile health interventions, particularly those using SMS text messaging, have been implemented to improve ART adherence, many lack a focus on specific behavioral mechanisms. Interventions incorporating behavioral change techniques (BCTs), especially those emphasizing customization, may enhance effectiveness. WhatsApp offers potential for delivering tailored, behaviorally grounded interventions with diverse communication features. We hypothesize that WhatsApp messages self-designed by participants, with spontaneous targeting of BCTs, could be more effective than standard WhatsApp messages designed by the researchers to improve ART adherence. Objective: The objective of this study is to evaluate the effectiveness of WhatsApp messages created by participants (self-designed) compared to WhatsApp messages designed by the researchers (standardized) over adherence to ART at 16 weeks of intervention in young people living with HIV who receive HIV care under routine conditions at a public hospital in Lima, Peru. Methods: A 2-arm randomized controlled trial with a parallel assignment of 1:1, with no blinding of study intervention, was performed. Eligible participants are consenting people living with HIV aged 18-29 years who receive HIV care at the study center and whose mobile phones support WhatsApp. Following informed consent and a baseline survey on clinical and personal preferences (eg, timing and frequency of messages), participants are randomized to the control group (messages designed by the research team) or to the experimental group (messages designed by participants), stratified by sex, educational level, current ART intake, and history of ART abandonment. Participants in both groups receive up to 3 WhatsApp messages per week for 16 weeks. ART adherence, the primary outcome, is measured using the Simplified Medication Adherence Questionnaire (SMAQ) at 4, 8, 12, and 16 weeks. Monthly feedback questionnaires on user experience are also administered. The WhatsApp chat format allows two-way communication between participants and the research team throughout the study. We will compare ART adherence between 2 groups at 16 weeks under the intention-to-treat principle, with no interim analysis planned. Based on an estimated 10% difference in adherence, 78.9% power, and a 2-sided α of .05, the target sample size was set at 120, later increased to 131 to include a 2-week pilot phase. Results: In March 2024, we started enrolling and randomizing participants. The study follow-up will continue until the last participant completes 16 weeks of intervention (November 2024). As of February 2025, we are in the process of data curation. Conclusions: This trial will compare the effectiveness of standardized vs self-designed WhatsApp messages on ART adherence measured at 16 weeks among young people living with HIV receiving routine care in a low-resource setting in Lima. Trial Registration: ClinicalTrials.gov NCT06500013; https://clinicaltrials.gov/ct2/show/NCT06500013

Background: The health sector collects a plethora of electronic health data via digital technologies, such as electronic health records (EHRs) and electronic medical records (EMRs). The primary use of EHRs includes supporting service delivery, providing data on patient information, and health care operations. Secondary uses of these systems can include quality improvement activities and research, and possibly inform policy. One underexplored secondary use of data from these systems is to enable health care professionals to understand their performance, reflect on their practice, and potentially support enhanced professional and workplace learning. There is growing interest and an increase in policies to focus on motivating the use of this type of data as part of mandatory Continuing Professional Development. Despite this, the design of EHRs is not conducive to the use of these systems for reflective practice, and there are few best practice guides for how to scaffold the use of these data for secondary use. Objective: The aim of this project is to determine how EHRs and EMRs can be leveraged to enable formative performance feedback for health care professionals. The primary objective is to explore the use of these systems by health care professionals to further understand the current and possible future use of these records for reflective practice, performance feedback, and workplace learning. Methods: The project will use a mixed methods design to enable a holistic picture of participant behaviors. Study data are being collected over 3 phases. Phase 1 consists of interviewing health care professionals and clinicians about their experiences with EHRs and EMRs. Phase 2 will involve surveying health care professionals about specific EHR features, and phase 3 will encompass workshopping discussions around EMR functionality and design with key informants. Participants for phases 1 and 2 will be a convenience sample of health care professionals who self-select and volunteer to participate in the study. Participants for phase 3 will consist of policy makers, representatives from peak bodies, technology vendors, health care professionals, and others. Data from phase 1 will be thematically analyzed to identify key features of EMR and EHR design for prioritization in phase 2. Phase 2 survey responses will be descriptively analyzed to understand the most important features in record design to support reflective practice. Phase 3 workshop data will be thematically analyzed to identify design insights for EHRs and EMRs that support professional learning. Results: The project is currently in its interview phase and is expected to publish results in mid-2025. Conclusions: The project will generate new knowledge on the extent to which data collected by workplace technologies provide health care professionals with formative performance feedback. It will also develop a conceptual design for EHRs that supports health care professional learning, which could be leveraged by developers of these technologies in future implementations.

Background: Invasive coronary angiography (ICA) is the gold standard in the diagnosis of coronary artery disease (CAD). Being invasive, it carries rare but serious risks including myocardial infarction, stroke, major bleeding, and death. A large proportion of elective outpatients undergoing ICA have nonobstructive CAD, highlighting the suboptimal use of this test. Coronary computed tomographic angiography (CCTA) is a noninvasive option that provides similar information with less risk and is recommended as a first-line test for patients with low-to-intermediate risk of CAD. Leveraging artificial intelligence (AI) to appropriately direct patients to ICA or CCTA based on the predicted probability of disease may improve the efficiency and safety of diagnostic pathways. Objective: he CarDIA-AI (Coronary computed tomographic angiography to optimize the Diagnostic yield of Invasive Angiography for low-risk patients screened with Artificial Intelligence) study aims to evaluate whether AI-based risk assessment for obstructive CAD implemented within a centralized triage process can optimize the use of ICA in outpatients referred for nonurgent ICA. Methods: CarDIA-AI is a pragmatic, open-label, superior randomized controlled trial involving 2 Canadian cardiac centers. A total of 252 adults referred for elective outpatient ICA will be randomized 1:1 to usual care (directly proceeding to ICA) or to triage using an AI-based decision support tool. The AI-based decision support tool was developed using referral information from over 37,000 patients and uses a light gradient boosting machine model to predict the probability of obstructive CAD based on 42 clinically relevant predictors, including patient referral information, demographic characteristics, risk factors, and medical history. Participants in the intervention arm will have their ICA referral forms and medical charts reviewed, and select details entered into the decision support tool, which recommends CCTA or ICA based on the patient’s predicted probability of obstructive CAD. All patients will receive the selected imaging modality within 6 weeks of referral and will be subsequently followed for 90 days. The primary outcome is the proportion of normal or nonobstructive CAD diagnosed via ICA and will be assessed using a 2-sided z test to compare the patients referred for cardiac investigation with normal or nonobstructive CAD diagnosed through ICA between the intervention and control groups. Secondary outcomes include the number of angiograms avoided and the diagnostic yield of ICA. Results: Recruitment began on January 9, 2025, and is expected to conclude in mid to late 2025. As of April 14, 2025, we have enrolled 81 participants. Data analysis will begin once data collection is completed. We expect to submit the results for publication in 2026. Conclusions: CarDIA-AI will be the first randomized controlled trial using AI to optimize patient selection for CCTA versus ICA, potentially improving diagnostic efficiency, avoiding unnecessary complications of ICA, and improving health care resource usage. Clinical Trial: ClinicalTrials.gov NCT06648239; https://clinicaltrials.gov/study/NCT06648239/

Background: Walking difficulties are a common and costly problem. However, disability associated with the decline in walking ability is not an inevitable consequence. With an aging population, it is increasingly important to establish strategies to help older adults preserve the capacity to live independently and function well in late life. Preclinical mobility limitation (PCML), which is characterized by subtle changes or limitations in mobility that precede disability, manifests as changes in how daily tasks such as walking are performed. Persons with PCML are at increased risk for the onset of disability and chronic disease. For that reason, PCML is a critical stage in the natural history of functional change when there is the opportunity for primary prevention interventions. Objective: To evaluate the effect of a 12-week online mobility self-management program (Stepping Up) on mobility outcomes, including walking speed, aerobic exercise capacity, dual-task cost, physical functioning (balance and strength), balance confidence, extent of community mobility, self-management of mobility, and quality of life in older adults with PCML. Methods: This randomized controlled trial (RCT) will recruit 249 older adults (aged 55-75 years) screened for PCML. Participants will be assigned to the Stepping Up program, a telephone-based coaching walking program or an online chair-based yoga program. Programs will be delivered over 12 weeks and participants will undergo virtual assessments with a blinded physiotherapist at baseline, 12, 24, and 36 weeks. An economic evaluation will be conducted alongside this RCT. Results: A total of 253 participants were enrolled in the trial. Data collection commenced in August 2021 and will be completed in October 2025. Data analysis will begin in November 2025 and results will be published in the Summer of 2026. Conclusions: To our knowledge, PCML has not been addressed by primary prevention interventions that incorporate both task-oriented motor learning exercise and mobility self-management sessions. Results will establish if the Stepping-Up program has the potential to serve as a model for sustainable, accessible, and cost-effective programming for individuals with early mobility limitations. Trial Registration: ClinicalTrials.gov NCT04368949; https://clinicaltrials.gov/study/NCT04368949

Background: Impaired gait adaptability is one of the major causes of falls among older adults owing to inappropriate gait adjustments in cluttered environments. Training programs designed to improve gait adaptability behavior in a systemic approach may prevent falls in older adults. Recently, virtual reality (VR) technology has been prominent as a relevant gait training tool because of its training implementation potential. Objective: This study was designed to compare the effectiveness of a VR-based gait training program (VR group) for improving gait adaptability behavior and, thus, reducing the risk of falls relative to a conventional training program such as Nordic walking (NW; NW group). We hypothesized that the VR-based gait training program will lead to greater gait adaptability improvements. Methods: We will be conducting a randomized controlled trial with pretests, posttests, retention tests, and follow-up. In total, 40 healthy independent-living community dwellers (aged between 65 and 80 years) will be allocated, after a general medical examination, to the VR or the NW group for a training program of 6 weeks. Primary outcomes related to gait adaptability capacities (ie, analysis of adjustments made in different locomotor tasks) and acceptance of the VR device (ie, analysis of acceptance) will be assessed before and after the intervention and 1 month after the completion of the training program (retention). A follow-up will be done during the 12 months after the completion of the gait training program. Results: Data collection will begin in September 2025, and the first results are expected in December 2025. Conclusions: The findings of this study may demonstrate the relative relevance of a gait training program in VR versus a conventional one for improving gait adaptability behavior in healthy older adults and, thus, prevent the chances of a fall.

Background: Individuals with autism spectrum disorder (ASD) often exhibit low dietary diversity due to food selectivity, leading to various forms of malnutrition, such as obesity or micronutrient deficiencies. Objective: The main objective of the AUT-MENU project is to improve meal acceptance among individuals with ASD. A secondary goal is to evaluate the effectiveness of a nutrition education course for parents of enrolled participants to reduce food selectivity. Methods: The study is a bicentric intervention conducted in 3 care centers (Pavia and Milan) and 1 secondary school (Rome), involving approximately 200 participants with ASD aged 3 to 35 years. The study consists of an observational phase (T0) and an intervention phase (T1). At T0, biographical data, clinical characteristics, and dietary patterns of participants are collected. Based on T0 findings and existing nutritional recommendations for individuals with ASD, targeted menus are developed and tested. At T1, the same assessment tools used at T0 will be applied to evaluate intervention effects. Additionally, a nutrition education course for caregivers will be implemented between T0 and T1, with a pre- and postcourse knowledge questionnaire to assess its effectiveness. Results: Due to different timelines depending on the centers and schools involved, participant enrollment and data collection will take place at different times between Pavia, Milan, and Rome. In September 2024, enrollment was held in the Pavia and Milan care centers for a total of 74 participants enrolled. In Rome, the enrollment phase has not yet started; activities are expected to be carried out similar to those in Pavia and Milan. Conclusions: The AUT-MENU study is expected to yield significant insights and improvements in meal acceptance among individuals with ASD, particularly through the introduction of targeted menus in collective catering settings both in care centers and schools. Trial Registration: ClinicalTrials.gov NCT06266377; https://clinicaltrials.gov/study/NCT06266377

Background: Severe weather events, exacerbated by climate change, can lead to hardships such as displacement, resource scarcity, and social network disruptions. Such disasters impact mental health, triggering conditions such as anxiety, depression, and posttraumatic stress disorder. For communities in the Gulf South, the increasing frequency of disasters often further exacerbates already disastrous levels of inequality. In this context, there is an urgent need for evidence-based, multilevel, community-based interventions to support individual and community mental health and resilience. Objective: This protocol describes the design of a community-based participatory research (CBPR) study to improve individual and community mental health in Gulf South communities by examining the implementation and effects of the multilevel, community-based intervention, Communities Organizing for Power through Empathy (COPE). Specifically, this study aims to (1) examine factors affecting the implementation, effectiveness, and adoption of the COPE intervention and (2) test its effects on mental health and community resilience. We hypothesize that participants in the COPE intervention will experience greater reductions in psychological distress (eg, perceived stress, anxiety, and depression); improvements in protective factors (eg, social support and coping self-efficacy); and community participation as compared with an attention control group. Methods: The Consolidated Framework for Implementation Research guides our analysis of data collected from surveys, fidelity and field notes, interviews, and focus groups to examine aim 1. We examine aim 2 primarily via a 2-arm pragmatic stepped-wedge cluster randomized trial (SW-CRT) with individuals (approximately n=300) in clusters (faith-based and secular community-based organizations; approximately n=15) in a disaster-prone community in the US Gulf Coast. The cluster-based design implemented in steps supports the community-based nature of the study where timelines differ by organization. A total of 5 self-assessments will be conducted both in person and via email at later time points. We will integrate mixed methods in our analyses for aim 1 by combining themes from interviews and focus groups with implementation measures, and for aim 2 by constructing a data matrix to combine findings from the SW-CRT with thematic analyses of field notes and interviews. Results: The SW-CRT is being conducted from June 2022 to June 2025. Recruitment began in April 2023, to conclude in spring 2025, to assess mental health, social support, and community resilience at 5 time points. Data analysis and dissemination of results are expected by spring of 2026. Conclusions: This protocol is among the first to use a CBPR approach to examine the implementation and effectiveness of a multilevel intervention on psychological distress and resilience. This study provides new insights into how CBPR can enhance intervention implementation research and expand the evidence on community-based mental health interventions during disasters. Policy makers should consider integrating CBPR approaches into disaster response frameworks to ensure culturally relevant and sustainable outcomes. Trial Registration: ClinicalTrials.gov NCT06093737; https://clinicaltrials.gov/study/NCT06093737

Background: A healthful diet in early childhood is essential for healthy growth and disease prevention. Parents influence children’s diets through supportive (eg, structure and autonomy support) and unsupportive (eg, coercive control and indulgence) food parenting practices. Historically, much of this work has focused on parents’ “usual” feeding behaviors using survey methods. However, recent studies using ecological momentary assessment methods have allowed assessment of food parenting behaviors in “real time.” This work has revealed that the practices used by parents to feed children vary across contexts and are influenced by factors such as stress or time constraints. Research is needed to understand the dynamic nature of food parenting and its impact on children’s diets. Objective: This study aimed to describe the methods and procedures used in the Preschool Plates cohort study, which aimed to (1) describe within- and between-day fluctuations in food parenting practices across time and context, (2) examine the longitudinal impact of within- and between-day fluctuations in food parenting practices on child dietary intake, and (3) identify momentary predictors of within- and between-day fluctuations in food parenting practices across time and context. Methods: Preschool Plates is a longitudinal cohort study examining the impact of food parenting practices on the dietary intake of 3- to 5-year-old children. A total of 273 parent-preschooler dyads consented and enrolled, and 254 (93%) dyads completed baseline data collection. Dyads will be followed for 2 years using state-of-the-art measures, including an 8-day ecological momentary assessment protocol to assess food parenting, contemporary measures of food parenting, and 3 interview-led 24-hour dietary recalls, collected at baseline, 6 months, 12 months, and 24 months. Child height and weight will be measured at 3 time points. Results: Recruitment for our baseline sample (N=254) occurred between October 2023 and September 2024. Participants will complete follow-up data collection after 6 months, 12 months, and 24 months. A racially and ethnically diverse cohort was enrolled, with 28.3% (72/254) of enrolled participants identifying as White and 71.7% (182/254) identifying as non-White. Conclusions: Findings from the proposed study will inform the development of anticipatory guidance for feeding young children and randomized controlled trials designed to intervene on parents’ responses to momentary factors to encourage interactions with children around feeding that promote optimal diet quality. For example, findings could inform the development of an ecological momentary (ie, real time) intervention that delivers content to participants’ mobile devices in response to real-time assessments of context and circumstance.