This study investigates how the development of digital finance influences the geographical distribution of corporate supply chains using data from Chinese A-share listed companies from 2010 to 2023. We examine whether digital finance enables firms to overcome traditional geographical constraints and adopt different supply chain distribution strategies. The analysis identifies two primary mechanisms through which digital finance influences supply chain geography: governance effects, which operate through enhanced risk management and information transparency, and financing effects, which function through alleviated capital constraints and trade credit provision. We further explore heterogeneous impacts across four dimensions: regional economic development, regional digital infrastructure, industry market competition, and enterprise lifecycle stages. By examining the geographical distribution of supply chains as an outcome of digital finance development, this study provides novel evidence on the micro-governance implications of digital finance. Our findings contribute to understanding how digital finance fundamentally changes the geographical constraints that have historically shaped supplier selection decisions and enables firms to develop more flexible supply chain configurations.

Background: Many mental health professionals face work-related stress due to high job demands, limited control, and inadequate institutional support. Connected mental health (CMH) technologies such as mobile apps and teletherapy platforms are increasingly being proposed as tools to alleviate these job demands. However, their actual influence on clinicians’ work environments—here understood as the organizational, social, and psychological conditions that shape their workload, job demands, autonomy, and overall well-being—remains underexplored. Existing reviews have primarily focused on traditional organizational interventions, leaving a critical gap in understanding how CMH technologies specifically influence the work environment of mental health clinicians. Objective: This systematic literature review aims to identify and summarize knowledge about the impact of CMH on the work environment of mental health clinicians. Methods: A systematic literature review will be performed. The review follows PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and has been registered in PROSPERO on April 23, 2025. A comprehensive search strategy was developed using the population, intervention, comparison, and outcome (PICO) framework in collaboration with an academic librarian. Studies will be sourced from the PubMed, Scopus, IEEE Xplore, and ACM Digital Library databases. Inclusion criteria are limited to empirical studies involving mental health clinicians using CMH tools, where outcomes explicitly relate to the work environment (eg, job demands, workload, autonomy, stress, or well-being). Eligible studies must be published in English. Data extraction will include publication trends, study methods, and types of CMH technologies. Additionally, the extraction will capture the study results, including qualitative and quantitative findings, along with the measurement instruments used. Two reviewers will independently select articles for review and extract data. Conflicts will be discussed, and a third reviewer will be consulted if a consensus cannot be reached. Descriptive statistics and thematic analysis (via NVivo) will be used to synthesize the findings. Results: This systematic literature review seeks to explore and synthesize existing research on how CMH technologies affect clinicians’ work environments and is expected to be completed by December 2025. Conclusions: This review will offer a comprehensive overview of how CMH technologies affect the professional work environment of clinicians. Trial Registration: PROSPERO CRD420251018685; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251018685 International Registered Report Identifier (IRRID): PRR1-10.2196/76668

Background: Individuals with poststroke hemiplegia often develop spasticity, which increases disability. Antispastic treatments such as baclofen and botulinum toxin are commonly prescribed in poststroke recovery. However, their impact on motor recovery, especially when administered within the first 2 months after stroke, remains unclear. Objective: This study aims to compare the motor recovery effects of botulinum toxin versus oral baclofen. The hypothesis is that botulinum toxin is more supportive of motor recovery than baclofen and enhances functional recovery. Methods: The study is a multicenter, controlled phase IV, comparative, prospective, randomized, double-blind, double-dummy, superiority trial to compare the toxin and baclofen, and a noninferiority trial to compare the toxin and the placebo. It focuses on the time course of the Fugl-Meyer Motor Assessment (FMA) as the primary outcome. The main inclusion criterion is patients with a single stroke in the past 2 months. Treatment comprises 1 intramuscular injection at treatment initiation and oral tablets for 4 months. Randomized patients are allocated to 3 arms: botulinum toxin with placebo baclofen, baclofen with placebo botulinum toxin, and placebo baclofen with placebo botulinum toxin. FMA scores are assessed at pretreatment, 1 month, and 3 months later. Spasticity, functional abilities, activities of daily living, pain, and quality of life are also evaluated. Adverse effects are monitored. A positive difference of 13 points in the FMA time course between the botulinum toxin and baclofen groups is considered a relevant effect. The data analysis plan involves linear regression models to compare primary and secondary outcomes, with adjustments for covariates such as age, center, and associated treatments. Subgroup analyses will examine proportional recovery profiles, and missing data in Fugl-Meyer scores will be addressed using imputation methods. Results: A total of 179 participants were randomized across 18 centers, with inclusions delayed due to the COVID-19 pandemic. As of December 2024, the data manager currently has all the data, and a review of data quality is in progress. No statistical analysis has been conducted so far, and the blind will be lifted after the analysis. Conclusions: This study identifies the most suitable spasticity treatment, considering the specificities of the stroke and constraints during the recovery phase. It will provide recommendations for the primary treatment of early spasticity post stroke. Trial Registration: ClinicalTrials.gov NCT02462317; https://clinicaltrials.gov/study/NCT02462317; European clinical trials (EudraCT) 2010-022881-28; https://www.clinicaltrialsregister.eu/ctr-search/trial/2010-022881-28/FR

Vaccination is a cost-effective strategy for reducing morbidity and mortality among children under 5 years old. To be fully protected from diseases such as tuberculosis, diphtheria, pertussis, and polio, children must receive all recommended vaccinations in a timely manner. In many countries, including Tanzania, high overall vaccination rates mask substantial regional variation in vaccination coverage and low rates of vaccination timeliness. This study evaluates the efficacy of mobile phone-based (mHealth) reminders and incentives for improving vaccination timeliness in the first year of life.

Background The challenges of living with and managing type 1 diabetes during youth and emerging adulthood are well documented. The management burden may be alleviated in part using diabetes technologies including continuous glucose monitoring and hybrid closed-loop insulin pumps. However, young people's experiences of diabetes technology during this life stage are not well understood. This study aims to address that gap. Methods This study will recruit 30–40 young people living with T1D, aged 16–21 years, from paediatric, transition and adult T1D clinics. Semi-structured qualitative interviews will be conducted. The data will be analysed using framework analysis. Results TBC (registered report format).

Extensive research has demonstrated that people can intentionally forget by inhibiting the retrieval of unwanted memories, a phenomenon known as suppression-induced forgetting (SIF). Although neuroimaging studies have linked retrieval suppression to the right lateral prefrontal cortex (LPFC), direct evidence for the causal role of this region plays in supporting SIF is still lacking. In this registered report, our aim is putting to a strong empirical test such an idea by using cathodal transcranial direct current stimulation in a standard think/no-think procedure. Across two experiments, we will compare the SIF achieved by participants receiving cathodal transcranial direct current stimulation over the right LPFC—which has been shown to disrupt prefrontally mediated inhibitory control—with those receiving sham stimulation or cathodal stimulation over a control site. In addition, we will examine the lateralization of this effect by comparing stimulation of the right and left LPFC. Our results will provide novel and critical insights into the brain mechanisms of inhibitory control.

Background: Neuropathic pain (NP) is characterized as pain arising from lesions of the somatosensory nervous system. However, NP-like features have been found in several chronic secondary musculoskeletal (MSK) pain conditions in the absence of detectable lesion or damage to the somatosensory pathways. Emerging evidence has demonstrated associations between NP-like symptoms and altered neural activity within brain regions implicated in sensory perception and affective-emotional processing of pain with consistent findings of abnormal activity in the right insula (RIns) cortex and dorsal anterior cingulate cortex (dACC). Electroencephalography neurofeedback (EEG-NF) is a brain-computer interface biofeedback technique that allows individuals to self-regulate the real-time cortical brain activities of the regions of interest.

Problem statement: Human-driven biodiversity loss continues worldwide, despite knowledge of its drivers. This has serious implications not only for nature but also for the resources and services biodiversity provides to humans, such as climate regulation and food provision. Small-scale conservation interventions aim to mitigate these issues in people's local environments and can engender a sense of agency and nature connectedness. However, we lack consensus about their effectiveness as studies of local-scale actions often find divergent effects on biodiversity. Furthermore, we do not know which conservation interventions are most effective in different spatial or taxonomic contexts. Methods: We aim to systematically review the evidence from peer-reviewed and grey literature on local-scale conservation interventions. We have designed a flexible, modular protocol allowing us to add further data in the future. We will initially make predictions about the impact of these interventions in English contexts, but the method is designed to be applicable globally. We will generate a series of datasets, each containing evidence about different interventions and their impact on species' abundance and diversity. We will use meta-analysis to estimate these interventions' impact on biodiversity. Depending on the data retrieved, we may also be able to investigate nuances such as which interventions work best for specific contexts or organisms, or whether impacts vary over time. We would do this using additional variables and/or data subsets. In publishing this protocol, and in using the most up-to-date, rigorous methods, we aim to mitigate potential biases arising from either the data or methodology. In the first instance, we will complete a meta-analysis of interventions involving increasing floral availability; however, this protocol will also be used for guiding future meta-analyses incorporating additional interventions. Practical implications: Our findings could be used to inform local-scale conservation management and conservation policy. The results of our initial application of this protocol will be used to inform conservation interventions in schools and colleges in England as part of the UK government's National Education Nature Park project. The collated data set will be made available for use by others wishing to investigate the impacts of local-scale conservation interventions in their own contexts.

Background: Globally, TB programs have enhanced efforts to improve case detection, treatment initiation and monitoring of treatment outcomes. However, there is less attention on reducing the number of presumptive TB patients that never get tested for TB or the confirmed ones that never start treatment in endemic areas, such as Uganda. These losses slow down progress towards attaining the 2035 End TB goals. The World Health Organization (WHO) recommends mobile health (mHealth) interventions such as short message services (SMS), phone calls, mobile phone applications and digital monitoring devices to improve universal health coverage. To our knowledge, there is limited evidence on whether these mHealth interventions can increase linkage to care for presumptive TB patients, particularly in sub-Saharan Africa. Objective: We propose a trial (MILEAGE4TB) whose aim is to assess the effect of SMS reminders, phone call reminders and transport incentives on improving linkage to care of presumptive TB patients in Uganda. Methods: This will be a five-arm individually randomised controlled trial among presumptive TB patients aged 18 years and above, who are referred for Xpert MTB/RIF testing. Participants will be randomized (2:2:2:1:1) to: (i) standard of care (ii) SMS only (iii) phone call only (iv) SMS and a transport incentive (v) phone call and a transport incentive. An estimated sample size of 2389 participants will be considered. Participants will be followed up for 30 days to see if they tested for TB and collected their results. Those who test positive for TB, will be followed for 14 days to measure treatment initiation. Analysis will be by intention to treat. Modified Poisson regression models will be used to estimate the effects of the interventions on completion of TB diagnosis and treatment initiation. Results: Results from this trial are not yet available. Recruitment of participants commenced on 14th August 2023. As of 28th December 2024, a total of 2355 participants (98.6%) were recruited. Results are expected once all study activities are complete in June 2025. Conclusions: This randomized controlled trial will provide insights on use of mHealth interventions to improve linkage to care of presumptive TB patients. Clinical Trial: The trial was registered at ClinicalTrials.gov, Number:NCT05964842.

The neural substrates of religious belief and experience are an intriguing though contentious topic. In the past decades, discussion has focused on the potential philosophical and theological implications of a so-called ‘God-spot’. At the same time the relatively few studies that have been conducted on the neurocognitive mechanisms involved in religion suffer from several methodological problems, such as inconsistency in the definition of religion and low sample sizes. Here we have the unique opportunity to establish the relation between validated measures of religiosity and gray matter volume in a large sample of participants (N = 224). In this registered report we propose to conduct a confirmatory Voxel-Based Morphometry (VBM) analysis to test three central hypotheses, according to which (1) an increased endorsement of religious beliefs is associated with a reduced volume of the orbitoprefrontal cortex, (2) an increased prevalence of mystical experiences is associated with reduced volume of the hippocampus and the right middle temporal gyrus, (3) increased religiosity and prevalence of mystical experiences is associated with volume changes of the bilateral inferior parietal lobe. The analysis plan, the processing pipeline and all analysis scripts will be made available online on the OSF. The ultimate aim of this study is to more clearly establish the relation between structural characteristics of the brain and religiosity and mystical experiences.

Children's early print and screen media experiences at home shape language and literacy development, but screen media can displace reading and vary by socioeconomic status (SES). This study examines how family stressors (economic strain, parent psychological distress, inter-relational stress) and protective factors (parent activity involvement, parenting self-efficacy, perceived parental impact, social support and external childcare) influence children's print and screen media experiences in lowerSES families. This study uses data from 222 mothers to child dyads (46% Black, 38% White) from the longitudinal SMALL Talk project, focusing on families experiencing poverty. Data were collected at children's age 40–44 months via interviews and online surveys. Findings will inform how family contexts can promote or hinder positive print and screen media engagement to support child development and school readiness.

Introduction Colorectal cancer (CRC) screening rates are lower among immigrant populations in the United States (US) than the general population. Immigrant communities face structural barriers that disincentivize their engagement from CRC screening. A growing body of literature has evaluated the effects of interventions aimed at increasing CRC screening engagement among various immigrant groups, but there has not yet been a systematic synthesis of this literature. Objective This review will systematically evaluate quantitative studies assessing the effects of interventions designed to increase CRC screening rates among immigrant populations residing in the US. Methods We will conduct a comprehensive search of English language peer-reviewed and grey literature using specific keywords and database-specific structured vocabulary on interventions to improve CRC screening rates among immigrants published in 7 databases (PubMed, Cochrane Library (Wiley), CINAHL (EBSCO), ClinicalTrials.gov, Embase (Ovid), Scopus (Elsevier), and Web of Science) from January 1, 2000 to December 31, 2024. All studies will be imported into Covidence. Two reviewers will independently screen titles, abstracts, and full-texts for inclusion and exclusion criteria. Pilot screenings and consensus discussions will ensure accuracy and agreement in study selection and data extraction. Iterative data extraction of eligible studies will include critical appraisal using the Risk of Bias 2 (ROB2) for randomized controlled trials, while other study designs will be appraised with the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool. Data synthesis will disaggregate pooled effect estimates by ethnicity, to the extent possible. The study protocol was pre-registered in International Prospective Register of Systematic reviews (PROSPERO): CRD42023488183. Expected outputs This systematic review aims to generate an exhaustive summary of the evidence base, including a description of the intervention methods and settings, target populations, recruitment and retention strategies, partnerships and collaborations, and reported outcomes. The results will provide actionable recommendations for public health practitioners, healthcare providers, and policymakers developing tailored interventions and policies aimed at improving CRC screening uptake among diverse immigrant populations in the US.

BACKGROUND: The development of colorectal neoplasia (precancerous lesions and colorectal cancer [CRC]) is linked to both non-modifiable and modifiable risk factors among average CRC risk populations. However, no longitudinal studies have assessed non-modifiable and modifiable risk factors and colorectal neoplasia risk among above-average risk CRC populations that require regular surveillance colonoscopy. Therefore, this research project will establish a large-scale colonoscopy surveillance dataset that collects lifestyle and clinical data at multiple time points to assess the effect of lifestyle changes over time on colorectal neoplasia risk. METHODS: A prospective follow-up study will be conducted among patients who are enrolled in a South Australian colonoscopy surveillance programme. About 21,000 patients will be invited to take self-reported surveys. Existing programme clinical data will be combined with annual prospectively collected survey data for three consecutive years. Surveys will capture changes in lifestyle patterns over time, including diet, physical activity, sleep quality, smoking habits, and alcohol consumption data at several time points using validated tools. Linear and generalised linear mixed effects models and joint modelling will be used to model continuous, categorical, and a combination of longitudinal and survival data on lifestyle scores and colorectal neoplasia risk, respectively. CONCLUSIONS: This study will be the first to investigate how changes in lifestyle patterns over time influence the development of early precancerous lesions and invasive cancer. Inclusion of high-risk lifestyle factors when recommending colonoscopy surveillance intervals could provide an improved, personalised CRC prevention strategy to reduce colorectal neoplasia incidence and colonoscopy workload in those at above-average risk of developing CRC.

Abstract Background Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. Methods We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. Discussion Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTR N12617001243303 Date/version: August 2019/two

This pre-registered report explores the safe-haven properties of sovereign currencies under the threat of rare disaster risk. Specifically, it address…

Women are widely assumed to be more talkative than men. Disconfirming this assumption, Mehl et al. (2007) provided the first empirical evidence that men and women do not differ significantly in daily word use, speaking about 16,000 words per day each. However, concerns were raised that their sample was too small to yield precise and generalizable estimates, and too age- and context-homogeneous to permit inferences beyond college students. This project replicates and extends the previous study of binary gender differences in daily word use to address these concerns. Pooling data for 2,197 participants (>5-fold the original sample size) from 22 samples (631,030 ambient audio recordings), it updates the estimates of women and men’s daily word use and evaluates the magnitude of their difference. It further explores the extent to which age (as a marker of developmental processes) and experienced stress (as a marker of biobehavioral coping processes) moderate this difference. Finally, it compares the general, age-, and stress-related gender-difference estimates for objectively-observed talkativeness (i.e., EAR-sampled daily word use) to the gender-difference estimates that emerge when looking at subjectively-rated talkativeness (i.e., self-reports of the respective Big Five Inventory item).

In this study, we propose a pre-registered replication of the research conducted by ten Brinke & Porter (2012). Their study identified four behavioural cues to deception that could distinguish deceptive murderers from genuinely distressed relatives, pleading for the safe return of a missing person, with a high degree of accuracy. By replicating this research using a new sample, we aim to assess the generalizability of these findings and provide further insights into the reliability of behavioral cues in distinguishing between deceptive and genuine pleaders.

Presented by OSF

Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to pay greater attention to policy, services, and research with respect to eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The Web-based platform, called Horyzons, was initially developed and tested in Australia and is now being prepared for evaluation in Canada. Methods: Service users and service providers from 2 specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection was completed in August 2017, and analysis and adaptation are in process. The first results of the study will be submitted for publication in 2018 and will provide preliminary insights into the acceptability of the Web-based platform (eg, perceived use and perceived usefulness) from service provider and service user perspectives. The project will also provide knowledge about the adaptations and process needed to prepare the platform for evaluation in Canada. Conclusions: This study contributes to an important gap in the literature pertaining to the specific principles, methods, and steps involved in adapting eHealth interventions for implementation and evaluation across a diverse range of cultural, geographical, and health care settings.

Background: Cardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients’ participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called “Future Patient” has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals. Methods: A randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients’, spouses’, and health care professionals’ experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies. Results: Data collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020. Conclusions: The expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure.

Introduction Exercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%–30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy. Methods and analysis In a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40–80 years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internetenabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3 months and 6 months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure.

Stress is one of, if not the, most ubiquitously studied risk factor across the health sciences. This unlikely to change given that the primary drivers of mortality and disability are chronic, stress-mediated illnesses (often highly comorbid with psychopathology). We argue that an important limitation of stress research is the consistency with which the Trier Social Stress Test is used when the research questions are not specific to social stress. We advocate for precision stress research using qualitatively different stressors to facilitate exploration of how different types of stressors might differentially impact health outcomes, including psychopathology. This registered report validates a reward-salient stress task (a modified Anger Incentive Delay Task; AIDT) in a sample of 101 emerging adults, over half of whom reported clinically relevant anxiety, hypo/mania, depression, and/or suicidal ideation, who participated in a study between 2020 and 2022. This task involves teaching participants a game where they can win money. Part way through, the “goal frustration” condition changes the rules such that correct responses to trials with anticipatory stimuli indicating the possibility to win money actually lose money on 56% of trials despite visual feedback indicating that responses were successful. Results consistently indicated that the AIDT successfully reduced positive emotions and motivation and increased negative emotions. The magnitude of these responses were predicted by individual differences in reward and punishment sensitivity. Given the breadth of psychopathologies that share both stress and reward and punishment sensitivity as risk factors, a reward-salient acute stress task is an important tool for precision psychopathology research.

Background: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. Objective: The aim of this paper is to describe the development of “Vascular View,” a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT).

Background: Multiple international agencies, including the World Health Organization and the International Monetary Fund, have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists. Objective: This study protocol aims to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period. Methods: A randomized controlled 2-group pretest and repeated posttest experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either the peer support intervention program or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week and twelfth week post childbirth. Results: The recruitment and training of peer support volunteers (N=20) ended in June 2017, whereas recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73, with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018. Conclusions: This study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother-child bond, and enhance overall family dynamics for mothers and infants. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14864807; http://www.isrctn.com/ISRCTN14864807 (Archived by WebCite at http://www.webcitation.org/6xtBNvBTX)

Background: Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks. Methods/Design: A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol. Discussion: To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults. Trial registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow.

Background: Depression during pregnancy and in the postpartum period is associated with a number of poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown great potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings, but there are significant barriers to scale-up. We are addressing this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users. Objective: The objective of this pilot study is to test the Healthy Moms perinatal depression intervention using a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya. Methods: We will invite patients to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants will be randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. Participants will be prompted to rate their mood via short message service every 3 days during the baseline and intervention periods. We will review system logs and conduct in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability. We will use visual inspection, in-depth interviews, and Bayesian estimation to generate preliminary data about the potential response to treatment. Results: Our team adapted the intervention content in April and May 2018 and completed an initial prepilot round of formative testing with 10 women from a private maternity hospital in May and June. In preparation for this pilot study, we used feedback from these users to revise the structure and content of the intervention. Recruitment for this protocol began in early 2019. Results are expected toward the end of 2019. Conclusions: The main limitation of this pilot study is that we will recruit women who live in urban and periurban centers in one part of Kenya. The results of this study may not generalize to the broader population of Kenyan women, but that is not an objective of this phase of work. Our primary objective is to gather preliminary data to know how to build and test a more robust service. We are working toward a larger study with a more diverse population. International Registered Report Identifier (IRRID): DERR1-10.2196/11800

Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention “MyPlan 2.0” targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective: The aim of this paper is to thoroughly describe “MyPlan 2.0” and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behavior. Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients’ stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted. Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019. Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time. International Registered Report Identifier (IRRID): DERR1-10.2196/12413

Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282

Background: Although smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy and remains poorly implemented. In addition, its current implementations tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with serious-gaming approaches remain largely unexplored and underdeveloped, even though they offer promise in terms of addressing the health workforce skill imbalance and lack of training opportunities associated with the high neonatal mortality rates in these settings. Objective: This randomized controlled study aims to assess the effectiveness of offering adaptive versus standard feedback through a smartphone-based serious game on health care providers’ knowledge gain on the management of a neonatal medical emergency. Methods: The study is aimed at health care workers (physicians, nurses, and clinical officers) who provide bedside neonatal care in low-income settings. We will use data captured through an Android smartphone-based serious-game app that will be downloaded to personal phones belonging to the study participants. The intervention will be adaptive feedback provided within the app. The data captured will include the level of feedback provided to participants as they learn to use the mobile app, and performance data from attempts made during the assessment questions on interactive tasks participants perform as they progress through the app on emergency neonatal care delivery. The primary endpoint will be the first two complete rounds of learning within the app, from which the individuals’ “learning gains” and Morris G intervention effect size will be computed. To minimize bias, participants will be assigned to an experimental or a control group by a within-app random generator, and this process will be concealed to both the study participants and the investigators until the primary endpoint is reached. Results: This project was funded in November 2016. It has been approved by the Central University Research Ethics Committee of the University of Oxford and the Scientific and Ethics Review Unit of the Kenya Medical Research Institute. Recruitment and data collection began from February 2019 and will continue up to July 31, 2019. As of July 18, 2019, we enrolled 541 participants, of whom 238 reached the primary endpoint, with a further 19 qualitative interviews conducted to support evaluation. Full analysis will be conducted once we reach the end of the study recruitment period. Conclusions: This study will be used to explore the effectiveness of adaptive feedback in a smartphone-based serious game on health care providers in a low-income setting. This aspect of medical education is a largely unexplored topic in this context. In this randomized experiment, the risk of performance bias across arms is moderate, given that the active ingredient of the intervention (ie, knowledge) is a latent trait that is difficult to comprehensively control for in a real-world setting. However, the influence of any resulting bias that has the ability to alter the results will be assessed using alternative methods such as qualitative interviews. Trial Registration: Pan African Clinical Trials Registry PACTR201901783811130; https://pactr.samrc.ac.za/TrialDisplay. aspx?TrialID=5836 International Registered Report Identifier (IRRID): PRR1-10.2196/13034

Background: People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment. Objective: The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment. Methods: People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual’s stage of HCV care, and a public discussion forum. Data on patients’ HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA–positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group. Results: Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA–positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody–positive, 129 (31%) had tested HCV antibody–negative within the past year and 85 (20%) had not been tested within the past year. Conclusions: The A-CHESS mobile health system allows for the implementation of a bundle of services as well as the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can improve HCV outcomes for people engaged in addiction treatment. Trial Registration: ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034 International Registered Report Identifier (IRRID): DERR1-10.2196/12620

Background: Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale.

Background: Self-management is integral for control of type 2 diabetes mellitus (T2DM). Patient self-management is improved when they receive real-time information on their health status and behaviors and ongoing facilitation from health professionals. However, timely information for these behaviors is notably absent in the health care system. Providing real-time data could help improve patient understanding of the dynamics of their illness and assist clinicians in developing targeted approaches to improve health outcomes and in delivering personalized care when and where it is most needed. Mobile technologies (eg, wearables, apps, and connected scales) have the potential to make these patient-provider interactions a reality. What strategies might best help patients overcome self-management challenges using self-generated diabetes-related data? How might clinicians effectively guide patient self-management with the advantage of real-time data? Objective: This study aims to describe the protocol for an ongoing study (June 2016-May 2019) that examines trajectories of symptoms, health behaviors, and associated challenges among individuals with T2DM utilizing multiple mobile technologies, including a wireless body scale, wireless glucometer, and a wrist-worn accelerometer over a 6-month period. Methods: We are conducting an explanatory sequential mixed methods study of 60 patients with T2DM recruited from a primary care clinic. Patients were asked to track relevant clinical data for 6 months using a wireless body scale, wireless glucometer, a wrist-worn accelerometer, and a medication adherence text message (short message service, SMS) survey. Data generated from the devices were then analyzed and visualized. A subset of patients is currently being interviewed to discuss their challenges and successes in diabetes self-management, and they are being shown visualizations of their own data. Following the data collection period, we will conduct interviews with study clinicians to explore ways in which they might collaborate with patients. Results: This study has received regulatory approval. Patient enrollment ongoing with a sample size of 60 patients is complete, and up to 20 clinicians will be enrolled. At the patient level, data collection is complete, but data analysis is pending. At the clinician level, data collection is currently ongoing. Conclusions: This study seeks to expand the use of mobile technologies to generate real-time data to enhance self-management strategies. It also seeks to obtain both patient and provider perspectives on using real-time data to develop algorithms for software that will facilitate real-time self-management strategies. We expect that the findings of this study will offer important insight into how to support patients and providers using real-time data to manage a complex chronic illness. International Registered Report Identifier (IRRID): DERR1-10.2196/13517

Background: Sleep disturbance in adolescents is common, with up to one-third reporting significant symptoms of insomnia. Research with adults has demonstrated that Web-based cognitive behavioral therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking, and we know little about whether CBTi would have similar effects on this younger population. Objective: This paper summarizes the protocol of a study to assess the feasibility of adding supported Web-based CBTi to the usual care of young people aged 14-17 years attending specialist Child and Adolescent Mental Health Services (CAMHS). Methods: This is an open trial where we will recruit young people (N=50) aged 14-17 years attending specialist CAMHS with primary or comorbid symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6-session, Web-based CBTi self-help program for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction, and cognitive techniques that participants will be helped to apply through brief, weekly telephone support calls. Questionnaires and interviews will be completed at baseline and postintervention (8-10 weeks) and will assess sleep, symptoms of depression and anxiety, and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and continued until the end of October 2018. Conclusions: This study will provide preliminary evidence about whether supported Web-based CBTi is acceptable to young people with mental health problems and about the postintervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomized trial to determine the effectiveness of Sleepio should be undertaken. International Registered Report Identifier (IRRID): DRR1-10.2196/11324

Background: Pediatric hematopoietic cell transplantation (HCT), commonly referred to as blood and marrow transplantation (BMT), is an intense treatment modality that requires the involvement of engaged caregivers during the patient’s (child’s) prolonged hospitalization. The ubiquity of electronic health records (EHRs) and a trend toward patient-centered care could allow a novel health information technology (IT) system to increase parental engagement. The paucity of research on acute care, hospital-based (inpatient) health IT applications for patients or caregivers provides an opportunity for testing the feasibility of such applications. The pediatric BMT population represents an ideal patient group to conduct an evaluation due to the lengthy inpatient stays and a heightened need for patient activation. Objective: The primary objective of this study is to assess the feasibility of implementing the BMT Roadmap in caregivers as an intervention during their child’s inpatient hospitalization. The BMT Roadmap is an inpatient portal prototype optimized for tablet with a user-centered design. It integrates patient-specific laboratory and medication data from the EHR in real-time and provides support in terms of discharge goals, home care education, and other components. Feasibility will be proven if (1) the BMT Roadmap functions and can be managed by the study team without unexpected effort, (2) the system is accessed by users at a defined minimum threshold, and (3) the qualitative and quantitative research conducted provides quality data that address the perceived usefulness of the BMT Roadmap and could inform a study in a larger sample size. Methods: This will be a single-arm, nonrandomized feasibility study. We aim to enroll 10 adult caregivers (age ≥ 18 years) of pediatric patients (aged 0-25 years) undergoing autologous (self-donor) or allogeneic (alternative donor) BMT. Assenting minors (aged 10-18) will also be invited to participate. Recruitment of study participants will take place in the outpatient pediatric BMT clinic. After signing an informed consent, the research study team will provide participants with the BMT Roadmap, available on an Apple iPad, which will used throughout the inpatient hospitalization. To measure the study outcomes, approximately 6-8 semistructured qualitative interviews will be conducted periodically from pre-BMT to 100 days post-BMT and an additional 15-20 semistructured interviews will be conducted among BMT health care providers to assess perceived usefulness and usability of the system, as well as any associated workflow impacts. Quantitative survey instruments will only be administered to adult participants (age ≥ 18 years). Results: Recruitment will begin in September 2015, and preliminary findings are expected in 2016. Conclusions: This protocol offers a framework for the design and analysis of a personalized health IT system that has the potential to increase patient and caregiver engagement in acute care, hospital-based contexts.

Background: HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. Objective: The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. Methods: This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. Results: App refinement is underway. Enrollment for the pilot RCT began in October 2018. Conclusions: MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.

: Excess weight is a major risk factor for chronic diseases. In Australia, over 60% of adults are overweight or obese. The overconsumption of energy-dense nutrient-poor (EDNP) foods and low physical activity (PA) levels are key factors contributing to population obesity. New cost-effective approaches to improve population diet and PA behaviors are needed. : This 1-year randomized controlled trial (6-month intervention and 6-month follow-up) aims to investigate whether a tailored intervention using mobile technology can improve diet and PA behaviors leading to weight loss in adults (aged 18-65 years) who are overweight or obese and recruited through a social marketing campaign (LiveLighter). : All eligible participants will provide data on demographics and lifestyle behaviors online at baseline, 6 months, and 12 months. Using two-stage randomization, participants will be allocated into one of three conditions (n=200 per group): tailored feedback delivered via email at seven time points, informed by objective dietary (mobile food record app) and activity (wearable activity monitor) assessment; active control receiving no tailored feedback, but undergoing the same objective assessments as tailored feedback; and online control receiving no tailored feedback or objective assessments. Primary outcome measures at 6 and 12 months are changes in body mass, EDNP food and beverage consumption, and daily moderate-to-vigorous PA (measured via accelerometry). Secondary outcomes include change in fruit and vegetable consumption, daily sedentary behaviors, and cost effectiveness. : Enrolment commenced in August 2017. Primary outcomes at 12 months will be available for analysis from September 2019. : Tailored email feedback provided to individuals may deliver a cost-effective strategy to overcome existing barriers to improving diet and PA. If found to be successful and cost effective, upscaling this intervention for inclusion in larger-scale interventions is highly feasible. : Australian New Zealand Clinical Trials Registry ACTRN12617000554369; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=371325&isReview=true

Background: Although nutrition interventions are a widely accepted resource for the prevention of long-term health conditions, current approaches have not adequately reduced chronic disease morbidity. Nutrigenomics has great potential; however, it is complicated to implement. There is a need for products based on nutrition-related gene test results that are easily understood, accessible, and used. Objective: The primary objective of this study was to compare a nonpractitioner-assisted direct-to-consumer self-driven approach to nutrigenomics versus an integrated and personalized practitioner-led method. Methods: This 4-month study used a mixed-methods design that included (1) a phase 1 randomized controlled trial that examined the effectiveness of a multifaceted, nutrition-based gene test (components assessed included major nutrients, food tolerances, food taste and preferences, and micronutrients) in changing health behaviors, followed by (2) a qualitative investigation that explored participants’ experiences. The study recruited 55 healthy males and females (aged 35-55 years) randomized as a 2:1 ratio where 36 received the intervention (gene test results plus integrated and personalized nutrition report) and 19 were assigned to the control group (gene test results report emailed). The primary outcomes of interest measures included changes in diet (nutrients, healthy eating index), changes in measures on General Self-efficacy and Health-Related Quality of Life scales, and anthropometrics (body mass index, waist-to-hip ratio) measured at baseline, post intervention (3 and 6 weeks), and the final visit (week 9 post intervention). Results: Of the 478 individuals who expressed interest, 180 were invited (37.7%, 180/478) and completed the eligibility screening questionnaire; 73 of the 180 invited individuals (40.5%) were deemed eligible. Of the 73 individuals who were deemed to be eligible, 58 completed the baseline health questionnaire and food records (79%). Of these 58 individuals, 3 were excluded either because they did not complete all required data collection forms or were later found to be ineligible. The final sample (n=55) was mostly female (75%), married (85%), and those who had completed postsecondary education (62%). Conclusions: This study will leverage quantitative and qualitative findings, which will guide the development of nutrigenomics-based products in electronic formats that are user-friendly for consumers and health professionals. Although the

Background: Outside health care, content tailoring is driven algorithmically using machine learning compared to the rule-based approach used in current implementations of computer-tailored health communication (CTHC) systems. A special class of machine learning systems (“recommender systems”) are used to select messages by combining the collective intelligence of their users (ie, the observed and inferred preferences of users as they interact with the system) and their user profiles. However, this approach has not been adequately tested for CTHC. Objective: Our aim was to compare, in a randomized experiment, a standard, evidence-based, rule-based CTHC (standard CTHC) to a novel machine learning CTHC: Patient Experience Recommender System for Persuasive Communication Tailoring (PERSPeCT). We hypothesized that PERSPeCT will select messages of higher influence than our standard CTHC system. This standard CTHC was proven effective in motivating smoking cessation in a prior randomized trial of 900 smokers (OR 1.70, 95% CI 1.03-2.81). Methods: PERSPeCT is an innovative hybrid machine learning recommender system that selects and sends motivational messages using algorithms that learn from message ratings from 846 previous participants (explicit feedback), and the prior explicit ratings of each individual participant. Current smokers (N=120) aged 18 years or older, English speaking, with Internet access were eligible to participate. These smokers were randomized to receive either PERSPeCT (intervention, n=74) or standard CTHC tailored messages (n=46). The study was conducted between October 2014 and January 2015. By randomization, we compared daily message ratings (mean of smoker ratings each day). At 30 days, we assessed the intervention’s perceived influence, 30-day cessation, and changes in readiness to quit from baseline. Results: The proportion of days when smokers agreed/strongly agreed (daily rating ≥4) that the messages influenced them to quit was significantly higher for PERSPeCT (73%, 23/30) than standard CTHC (44%, 14/30, P=.02). Among less educated smokers (n=49), this difference was even more pronounced for days strongly agree (intervention: 77%, 23/30; comparison: 23%, 7/30, P<.001). There was no significant difference in the frequency which PERSPeCT randomized smokers agreed or strongly agreed that the intervention influenced them to quit smoking (P=.07) and use nicotine replacement therapy (P=.09). Among those who completed follow-up, 36% (20/55) of PERSPeCT smokers and 32% (11/34) of the standard CTHC group stopped smoking for one day or longer (P=.70). Conclusions: Compared to standard CTHC with proven effectiveness, PERSPeCT outperformed in terms of influence ratings and resulted in similar cessation rates. ClinicalTrial: Clinicaltrials.gov NCT02200432; https://clinicaltrials.gov/ct2/show/NCT02200432 (Archived by WebCite at http://www.webcitation.org/6lEJY1KEd)

Background: Data collected by health care organizations consist of medical information and documentation of interactions with patients through different communication channels. This enables the health care organization to measure various features of its performance such as activity, efficiency, adherence to a treatment, and different quality indicators. This information can be linked to sociodemographic, clinical, and communication data with the health care providers and administrative teams. Analyzing all these measurements together may provide insights into the different types of patient behaviors or more accurately to the different types of interactions patients have with the health care organizations.

Background: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. Objective: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients’ perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). Methods: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. Results: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. Conclusions: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids.

Background: Hypertension remains one of the foremost noncommunicable diseases that most often lead to cardiovascular diseases and its different complications. The prevalence of hypertension in Bangladesh has been increasing. However, there are very limited studies that have evaluated the impact of health education and awareness development in mitigating the burden of hypertension and its complications in Bangladesh. Objective: This study aims to increase awareness, enhance knowledge, and change lifestyle behaviors through health education and the use of mobile health (mHealth) technology among individuals with hypertension living in a rural community of Bangladesh. Methods: A randomized controlled trial is underway in a Mirzapur subdistrict of Bangladesh. This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone–based text message intervention. The trial duration is 5 months. The primary end point is participants’ actual behavior changes brought about by increased awareness and knowledge. Results: Enrollment of participants started in August 2018, and collection of follow-up data was completed at the end of July 2019. A total of 420 participants volunteered to participate, and among them, 209 and 211 were randomly allocated to the intervention group and the control group, respectively. Among them, the ratio of males/females was 12.0/88.0 in the intervention group and 16.1/83.9 in the control group. Data cleaning and analyses have been completed and the results have been submitted for publication. Conclusions: Periodic short education using mHealth technology in addition to face-to-face health education may be an effective method for increasing awareness and knowledge about behavioral changes and maintaining healthy lifestyle behaviors. Trial Registration: Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104, https://clinicaltrials.gov/ct2/show/NCT03614104; University hospital Medical Information Network (UMIN) R000033736, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000033736 International Registered Report Identifier (IRRID): DERR1-10.2196/15523

Major postoperative morbidity and mortality remain common despite efforts to improve patient outcomes. Health information technologies have the potential to actualize advances in perioperative patient care, but failure to evaluate the usability of these technologies may hinder their implementation and acceptance. This protocol describes the usability testing of an innovative telemedicine-based intra-operative clinical support system, the Anesthesiology Control Tower, in which a team led by an attending anesthesiologist will use a combination of established and novel information technologies to provide evidence-based support to their colleagues in the operating room.

Background: The association between behavioral difficulties and academic attainment is well established. Recent policy advising schools on managing behavior has promoted the early identification of behavioral difficulties. There is also increasing research into mHealth interventions to provide support for emotional and behavioral difficulties for young people. Objective: The primary aim of the proposed research is to examine the effectiveness of an mHealth intervention, ReZone, in reducing emotional and behavioral difficulties in young people. Methods: The protocol is a cluster trial of 12 classes with N=120 students with classes randomized to ReZone or management as usual. Multilevel modeling will be used to compare ReZone versus management as usual accounting for classroom-level variation. Results: Baseline data collection started in February 2017 and ended in April 2017. Follow-up data collection started in April 2017 and ended in June 2017. Conclusions: The proposed research will provide evidence as to whether ReZone is effective at helping young people to self-manage when feeling overwhelmed. Trial Registration: ISRCTN 13425994; http://www.isrctn.com/ISRCTN13425994 (Archived by WebCite at http://www.webcitation.org/6tePwwiHk)

Background: Physiotherapy is essential for the successful rehabilitation of common shoulder injuries and following shoulder surgery. Patients may receive some training and supervision for shoulder physiotherapy through private pay or private insurance, but they are typically responsible for performing most of their physiotherapy independently at home. It is unknown how often patients perform their home exercises and if these exercises are performed correctly without supervision. There are no established tools for measuring this. It is, therefore, unclear if the full benefit of shoulder physiotherapy treatments is being realized. Objective: The proposed research will (1) validate a smartwatch and machine learning (ML) approach for evaluating adherence to shoulder exercise participation and technique in a clinical patient population with rotator cuff pathology; (2) quantify the rate of home physiotherapy adherence, determine the effects of adherence on recovery, and identify barriers to successful adherence; and (3) develop and pilot test an ethically conscious adherence-driven rehabilitation program that individualizes patient care based on their capacity to effectively participate in their home physiotherapy. Methods: This research will be conducted in 2 phases. The first phase is a prospective longitudinal cohort study, involving 120 patients undergoing physiotherapy for rotator cuff pathology. Patients will be issued a smartwatch that will record 9-axis inertial sensor data while they perform physiotherapy exercises both in the clinic and in the home setting. The data collected in the clinic under supervision will be used to train and validate our ML algorithms that classify shoulder physiotherapy exercise. The validated algorithms will then be used to assess home physiotherapy adherence from the inertial data collected at home. Validated outcome measures, including the Disabilities of the Arm, Shoulder, and Hand questionnaire; Numeric Pain Rating Scale; range of motion; shoulder strength; and work status, will be collected pretreatment, monthly through treatment, and at a final follow-up of 12 months. We will then relate improvement in patient outcomes to measured physiotherapy adherence and patient baseline variables in univariate and multivariate analyses. The second phase of this research will involve the evaluation of a novel rehabilitation program in a cohort of 20 patients. The program will promote patient physiotherapy engagement via the developed technology and support adherence-driven care decisions. Results: As of December 2019, 71 patients were screened for enrollment in the noninterventional validation phase of this study; 65 patients met the inclusion and exclusion criteria. Of these, 46 patients consented and 19 declined to participate in the study. Only 2 patients de-enrolled from the study and data collection is ongoing for the remaining 44. Conclusions: This study will provide new and important insights into shoulder physiotherapy adherence, the relationship between adherence and recovery, barriers to better adherence, and methods for addressing them.

Background: In the last decade, electronic health (eHealth) literacy has attracted the attention of the scientific community, as it is associated with the self-management of patients with chronic diseases and the quality and cost of care. It is estimated that 80% of people with chronic diseases are cared for at home by a family member, friend, or relative. Informal carers are susceptible to physical and mental health problems, as well as social and financial hardships. Nevertheless, there seems to be a research gap in terms of carers’ needs, skills, and available resources in the age of new technologies, with the vital role of eHealth literacy of the carers remaining unexplored. Objective: The aim of this study was to investigate the level of eHealth literacy and health literacy of primary and secondary carers of people with dementia, to explore the association between health and eHealth literacy, as well as their association with the caregiving variables: self-efficacy, coping, and caring perceptions. Methods: A sample of 200 primary carers (the carer who supports the people with dementia in everyday living) and 200 secondary carers (family member, friend, or other person in the social network assisting the primary carer in their role) will be recruited from dementia day care centers and Alzheimer’s associations in Greece and Cyprus. The study will be a cross-sectional correlational descriptive study. Tools to be used include the eHealth Literacy Scale adapted for carers to measure eHealth literacy, European Health Literacy Survey Questionnaire 16 (HLS-EU-Q16), Single Item Literacy Screener, Revised Scale for Caregiving Self-Efficacy, Carers of Older People in Europe (COPE) index for caregiving perceptions, and COPE brief to measure selected coping strategies. Descriptive statistics will be reported, and correlations between different variables will be explored with parametric and nonparametric measures. Results: As a preliminary study, the HLS-EU-Q16 has been validated in 107 older people. The internal consistency of the scale as estimated using Cronbach alpha coefficient was .77, somewhat lower than other validation studies. Recruitment of pilot study participants started in May 2017. Conclusions: Carers’ eHealth literacy is a new field. Whereas previous studies have focused on the role and impact of low eHealth literacy and health literacy among older adults, the eHealth literacy of carers, and in fact carers of people with dementia, has not been explored. We hypothesize an association between eHealth literacy and health literacy level with carers’ perceptions about caregiving role, self-efficacy, and coping strategies. A possible moderator in these associations is the secondary carers’

Background: Cancer survivorship in Ireland is increasing in both frequency and longevity. However, a significant proportion of cancer survivors are overweight. This has negative implications for long-term health outcomes, including increased risk of subsequent and secondary cancers. There is a need to identify interventions, which can improve physical and psychological outcomes that are practical in modern oncology care. Mobile health (mHealth) interventions demonstrate potential for positive health behavior change, but there is little evidence for the efficacy of mobile technology to improve health outcomes in cancer survivors. Objective: This study aims to investigate whether a personalized mHealth self-management lifestyle program is acceptable to participants and can improve physical and psychological outcomes of a subgroup of cancer survivors with increased health risks related to lifestyle behaviors. Methods: A sample of 123 cancer survivors (body mass index >25 kg/m2) was randomly assigned to the control (n=61) or intervention (n=62) group. The intervention group attended a 4-hour tailored lifestyle information session with a physiotherapist, dietician, and clinical psychologist to support self-management of health behavior. Over the following 12 weeks, participants engaged in personalized goal setting to incrementally increase physical activity (with feedback and review of goals through short message service text messaging contact). Objective measures of health behavior (ie, physical activity) were collected using Fitbit (Fitbit, Inc). Data on anthropometric, physiological, dietary behavior, and psychological measures were collected at baseline (T0), 12 weeks (T1; intervention end), and 24 weeks (T2; follow-up). Semistructured interviews were conducted to explore the retrospective acceptability of the Moving On program from the perspective of the recipients. Results: This paper details the protocol for the Moving On study. The project was funded in August 2017. Enrolment started in December 2017. Data collection completed in September 2018. Data analysis is underway, and results are expected in winter 2019. Conclusions: The results of this study will determine the efficacy and acceptability of an mHealth intervention using behavior change techniques to promote health behaviors that support physical health and well-being in cancer survivors and will therefore have implications for health care providers, patients, health psychologists, and technologists. International Registered Report Identifier (IRRID): DERR1-10.2196/13214

Background: Especially for single older adults with chronic diseases, physical inactivity and a poor social network are regarded as serious threats to their health and independence. The Active Plus intervention is an automated computer-tailored eHealth intervention that has been proven effective to promote physical activity (PA) in the general population of adults older than 50 years. Objective: The aim of this study was to report on the methods and results of the systematic adaptation of Active Plus to the wishes and needs of the subgroup of single people older than 65 years who have one or more chronic diseases, as this specific target population may encounter specific challenges regarding PA and social network. Methods: The Intervention Mapping (IM) protocol was used to systematically adapt the existing intervention to optimally suit this specific target population. A literature study was performed, and quantitative as well as qualitative data were derived from health care professionals (by questionnaires, n=10) and the target population (by focus group interviews, n=14), which were then systematically integrated into the adapted intervention. Results: As the health problems and the targeted behavior are largely the same in the original and adapted intervention, the outcome of the needs assessment was that the performance objectives remained the same. As found in the literature study and in data derived from health professionals and focus groups, the relative importance and operationalization of the relevant psychosocial determinants related to these objectives are different from the original intervention, resulting in a refinement of the change objectives to optimally fit the specific target population. This refinement also resulted in changes in the practical applications, program components, intervention materials, and the evaluation and implementation strategy for the subgroup of single, chronically impaired older adults. Conclusions: This study demonstrates that the adaptation of an existing intervention is an intensive process in which adopting the IM protocol is an invaluable tool. The study provides a broad insight in adapting interventions aimed at single older adults with a chronic disease. It is concluded that even when the new target population is a sizable segment of the original target population, the adapted intervention still needs considerable changes to optimally fit the needs and situational differences of the narrower target population.

Background: Smoking is the largest preventable cause of morbidity and mortality in Brazil. Education Against Tobacco (EAT) is a large network of medical students in 13 countries who volunteer for school-based prevention in the classroom setting. A recent quasi-experimental EAT study conducted in Germany showed significant short-term smoking cessation effects on 11- to 15-year-old adolescents.