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: 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 <7500 steps per day) African American men (n=100) aged >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

Background: Pediatric to adult health service (AHS) transition is an inevitable but challenging time for many adolescents and young adults (AYAs) with a chronic illness. As the responsibility of illness management begins to shift from parents to the AYA themselves, many AYAs fail to transition in a timely manner which has important health consequences. Mobile apps have the potential to assist AYAs in self-managing their condition during this vulnerable time, but empirical data on app uptake as well as efficacy with respect to transition outcomes and illness control are lacking. Objective: This pragmatic, single arm pilot trial aimed to evaluate AYA usage of a mobile app called ‘TransitionMate’ (TMApp) which was purpose-built to support chronic illness self-management for youth undergoing transition. Secondary aims were to assess AHS attendance and changes in illness control over the first 12 months post-transition. Upon demonstration of TMApp feasibility (≥70% of participants using TMApp at least once a month), a randomized controlled trial was planned to test efficacy of the app in relation to transition and illness control outcomes. Methods: AYAs aged 16-19 years who were transitioning out of two major pediatric hospitals in Sydney, Australia were recruited. Just prior to transition, participants’ demographic and clinical details were collected and TMApp was installed on their mobile devices. Participants were contacted by telephone at six and 12 months for information on self-reported usage, app usefulness and other feedback. Quantitative cohort-level usage data, including the number of times specific app features were accessed, was tracked via mobile analytics. At 12 months, electronic medical records (eMR) from participants’ designated AHS were accessed for data on AHS attendances, measures of illness control and unplanned hospitalizations. Results: 73 AYAs (30 male; median age 18 years) were recruited, with one withdrawing participation in the first month. Participants were primarily from three chronic illness subgroups: diabetes mellitus (n=23); inflammatory bowel disease (n=19); and cystic fibrosis (n=9). 50% of participants reported using TMApp at one month post-transition. Self-reported usage rates subsequently fell to 25% and 11% at six and 12 months, respectively. Mobile analytics data broadly corroborated self-reported usage. Eight participants who continued to use TMApp until 12 months gave a median usefulness rating of 8/10. Over two-thirds (68%) of participants successfully transitioned to their designated AHS by 12 months. Among the successful transitioners who had illness control data available on eMR, over 80% maintained a stable/improved illness status at six and 12 months. Conclusions: Results showed that TMApp was not used regularly enough by AYAs to demonstrate feasibility and justify progression to a randomized controlled trial. Despite low app uptake, over two-thirds of participants successfully transitioned suggesting that TMApp had minimal influence on transition outcomes. Clinical Trial: Australian New Zealand Clinical Trials Registry ACTRN12620000074998; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377349&isReview=true.