• A multiple technology-based physical activity intervention for Latina adolescents in the USA: randomized controlled trial study protocol for Chicas Fuertes

    stage 1 + 2verified

    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

    Jacob R. Carson, Emily Greenstadt, Brittany Olivera, Shira Dunsiger, Michelle Zive, Michael Higgins, Job Godino, Bess Marcus, Dawn Meyer, Britta Larsen·2025·JMIR mHealth and uHealth
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  • A Chatbot-Based Version of a World Health Organization–Validated Intervention (Self-Help Plus) for Stress Management in Pregnant Women: Protocol for a Usability Study

    stage 1

    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.

    Silvia Rizzi, Valentina Fietta, Lorenzo Gios, Stefania Poggianella, Maria Chiara Pavesi, Chiara De Luca, Debora Marroni, Claudia Paoli, Anna Gianatti, Barbara Burlon, Vanda Chiodega, Barbara Endrizzi, Angela Giordano, Francesca Biagioli, Veronica Albertini, Marianna Purgato, Corrado Barbui, Chiara Guella, Erik Gadotti, Stefano Forti, Fabrizio Taddei·2025·JMIR Research Protocols
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  • A Culturally Tailored mHealth Intervention (MobileMen App) to Promote Physical Activity in African American Men: Protocol for a Comparative Effectiveness Trial

    stage 1

    Background: African American men are at a higher risk for serious health conditions such as cardiovascular disease, diabetes, and stroke compared to non-Hispanic White men. Physical activity (PA) is a modifiable health behavior that has been shown to decrease chronic disease risk; yet, PA engagement is alarmingly low in African American men. Interventions to improve PA engagement are effective in a number of populations; however, very few have been tailored to the unique needs of African American men. Even fewer have leveraged mobile health apps, despite African American men’s interest in and willingness to use such technologies for health improvement. Objective: This comparative effectiveness trial aims to evaluate MobileMen, a PA promotion app tailored to the needs and preferences of African American men. This trial will compare the MobileMen app to a commercially available PA promotion app with similar features but lacks culturally tailored components. Methods: We will recruit a sample of “low active” (accumulating &lt;7500 steps per day) African American men (n=100) aged &gt;30 years from Baton Rouge, Louisiana, and the surrounding communities. All participants are given a Fitbit Charge 6 wearable activity tracker to assess daily PA and steps and are randomized to either the MobileMen intervention app or the comparator app, which is a commercially available PA tracking app called Stridekick. The Stridekick app has features similar to those in the MobileMen app but was not intentionally designed for African American men. The intervention period is 6 months during which participants will interact with their assigned mobile app. MobileMen includes features such as digital badges earned for PA; tangible prizes like exercise equipment; challenges among participants; goal setting; nutrition; PA; and behavior change educational information in text, audio, and video formats. Participants will complete assessments at baseline and at 6 months post randomization. Assessments include objective measurements of daily steps and minutes of moderate to vigorous PA, quality of life, dietary measures, self-efficacy for fruit and vegetable consumption and PA, and autonomous motivation for PA. Results: This trial is in the start-up phase. The MobileMen app development and usability testing was completed in August 2024. Participant recruitment efforts began in October 2024. The trial and associated data analyses and interpretation are planned to be completed by fall 2025. Conclusions: Mobile apps are a widely accessible means to disseminate culturally tailored PA promotion interventions to various populations, including African American men. MobileMen has the potential to impact PA engagement in African American men, which would dramatically improve the overall health and chronic disease risk in this underrepresented group. Trial Registration: ClinicalTrials.gov NCT05621044; https://clinicaltrials.gov/study/NCT05621044

    Kayla Nuss, Amanda Brice, Callie Hebert, Phillip Nauta, April J. Stull, Damon L. Swift, Derek M. Griffith, David B. Buller, Robert L. Newton Jr·2025·JMIR Research Protocols
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  • A Mobile Ecological Momentary Intervention for Reducing Experiential Avoidance in the Context of Rumination: Protocol for a Randomized Controlled Trial

    stage 1

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

    Steven Barnes, Marta Szastok, Małgorzata Para, Fabian Morawiec, Maciej Grzeszczuk, Szymon Wójcik, Barbara Karpowicz, Pavlo Zinevych, Anna Jaskulska, Wiesław Kopeć, Monika Kornacka·2025·JMIR Research Protocols
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