3 registered reports
Background: Background: Latina adolescents report low levels of moderate-vigorous physical activity (MVPA) and high lifetime risk of lifestyle-related diseases. There is a lack of MVPA interventions targeted at this demographic despite documented health disparities. Given their high rates of using mobile technology, interventions delivered through mobile devices may be effective for this population. Objective: Objective: The current paper examines efficacy of the Chicas Fuertes intervention in increasing MVPA across six months in Latina adolescents. Methods: Methods: Participants were Latina adolescents (ages 13-18) in San Diego County who reported being underactive (<150 minutes/week of MVPA). All participants received a wearable fitness tracker (Fitbit Inspire HR); half were randomly assigned to also receive the multimedia intervention. Intervention components included a personally tailored website, personalized texting based on Fitbit data, and social media. The primary outcome was change in minutes of weekly MVPA from baseline to six months (6m), measured by ActiGraph accelerometers and the 7-Day Physical Activity Recall Interview. Changes in daily steps using Fitbit devices were also examined to test intervention efficacy. Results: Results: Participants (N=160) were 15.3 years old on average, and mostly second generation in the U.S. For ActiGraph-measured MVPA, participants in the Intervention group (N=83) increased from a median of 0 min/week at baseline (IQR 26) to 64 min/week at 6m (IQR 28) compared to Control participants, who showed increases from a median of 0 at baseline (IQR 24) to 41 min/week at 6m (IQR 21) (P=.04). Self-reported MVPA increased in the Intervention group from a median of 119 min/week at baseline (IQR 122.5) to 147 min/week at 6m (IQR 85) compared to Control participants, who showed increases from a median of 120 (IQR 186.25) at baseline to 124 min/week at 6m (IQR 69) (P=.03). Steps also increased in both groups, with the Intervention group showing significantly greater increases (P=.03). Conclusions: Conclusions: This intervention was successful in using a tailored technology-based strategy to increase MVPA in Latina adolescents and provides a promising approach for addressing a key health behavior. Given the scalable technology used, future studies should focus on broad scale dissemination to address health disparities. Clinical Trial: ClinicalTrials.gov NCT04190225; https://clinicaltrials.gov/study/NCT04190225?id=NCT04190225
Background: Pregnancy is a complex period involving significant physical, mental, and social changes in a woman’s life, affecting her psychological well-being. According to the literature, anxiety, stress, and depression are common symptoms among pregnant women. Promoting a healthy lifestyle with a focus on mental health is essential. In this context, digital solutions such as coaches on smartphones are emerging as valuable tools to support the psychological well-being of pregnant women without existing disorders. Objective: This study aims to present the research protocol of a pilot study designed as a proof-of-concept investigation. The study evaluates the feasibility, acceptability, and utility of an acceptance and commitment therapy–based stress management mobile app. The primary objective is to explore the feasibility of using a coach, ALBA (A Well-Being Assistant), developed within the TreC Ricerca app, to promote women’s psychological well-being during pregnancy through 5 sessions based on acceptance and commitment therapy. The pre- and postintervention effects on psychological well-being will also be explored as a secondary objective, serving as a proxy for the potential impact of the intervention. Methods: The study serves as a proof-of-concept investigation, where a small sample size (N=50) is deemed adequate to fulfill the study’s objectives. Participant recruitment will be conducted among pregnant women affiliated with the pregnancy care services of the Azienda Provinciale per i Servizi Sanitari di Trento, using a convenience sampling approach. ALBA will interact with the participating women for 6 weeks, between the 14th and 26th weeks of gestation. Specifically, there will be 1 session per week, which the woman can choose, to allow more flexibility regarding her needs, supplemented by ALBA-supported exercises to be performed between sessions. This study adopts a mixed methods approach, combining quantitative and qualitative data collection and analysis. Usability and engagement are assessed using the System Usability Scale, Chatbot Usability Questionnaire, User Engagement Scale-Short Form, and the User Mobile Rating Scale. Moreover, other quantitative outcome measures include levels of stress, anxiety, depression, emotional regulation, psychological flexibility, coping strategies, self-efficacy, and overall well-being, along with qualitative data from semistructured interviews. Finally, the analysis of the data gathered in this study will primarily adopt descriptive statistics and a text mining approach, focused on evaluating the attainment of the study objectives and changes over experimental time. Results: The psychoeducational approach aims to yield notable outcomes regarding the usability and engagement of women with ALBA. Furthermore, an anticipated enhancement in psychological well-being and quality of life is expected. Conclusions: Existing literature indicates a preference among women in the perinatal period for online support, highlighting the potential of digital interventions to address barriers related to social stigma and seeking assistance. In this context, ALBA emerges as a valuable resource, providing consistent psychoeducational support for women throughout pregnancy.
Background: Research indicates that many autistic adults are insufficiently active and overly sedentary. There is limited evidence on effective strategies to increase physical activity (PA) and reduce sedentary behavior (SB) in this population. Gamified mobile health (mHealth) interventions show promise for addressing these challenges by leveraging autistic individuals’ strengths in visuospatial learning and their affinity for digital gaming. Despite this potential, it remains unclear how well these interventions translate to real-world settings. This gap is compounded by the lack of community-based participatory approaches in the development of mHealth intervention for autistic adults. Objective: This study aims to (1) formulate gamification and behavior change strategies for the PuzzleWalk v2 app using a community-based participatory approach and (2) evaluate its feasibility and acceptability for increasing PA and reducing SB among autistic adults, including those with mild intellectual disability, in real-world settings. Methods: This study, consisting of 2 sequential phases, will be conducted entirely remotely: (1) online community-based design workshops to refine the PuzzleWalk gamified mHealth system with input from key autism stakeholders, including autistic adults and caregivers, and (2) an 8-week field deployment to assess real-world usability and engagement. In Phase I (completed), weekly workshops and usability testing focused on understanding autistic adults’ technology preferences, evaluating PuzzleWalk v1 and v2 prototypes, and incorporating stakeholder feedback into iterative app development (n=9). Phase II (in progress) will involve a single-arm clinical trial where approximately 70 participants will use the app alongside research-grade activity-tracking accelerometers to measure PA and SB. Outcome measures, including sedentary time, step counts, PA intensities, and app engagement (eg, time spent using the app), will be collected across 4 specific time points (ie, baseline and weeks 3, 5, and 8). Repeated measures ANCOVA will be performed to examine changes in participants’ objective levels of PA and sedentary time before, during, and after the intervention. Results: Phase I of the study, involving community-based participatory design workshops and usability testing, was completed in November 2024. Key autism stakeholders recognized the gamified PuzzleWalk app as a viable tool for enhancing motivation toward PA and SB changes among autistic adults. Data collection for Phase II, the field deployment, is currently underway and is expected to end in August 2025. As of July 2025, we had enrolled 69 participants in the study. The findings of these studies will be shared in a subsequent peer-reviewed publication. Conclusions: Results of the ongoing field deployment study (Phase II) will further clarify the app’s effectiveness and real-world applicability. Trial Registration: ClinicalTrials.gov NCT06566131; https://clinicaltrials.gov/study/NCT06566131