Leveraging Mobile and Wearable Technology to Facilitate Healthy Behaviors in Children and Adolescents with Down Syndrome.

. In line with NIH’S INCLUDE research plan (NOT-OD-24-044), we propose to develop a multicomponent intervention that combines mobile and wearable technologies to facilitate healthy behaviors (physical activity, diet, sleep) and improve quality of life and nutritional status among children and adolescents with Down Syndrome (DS). Individuals with DS are at higher risk for lifestyle related adverse health outcomes including obesity and sleep apnea, which can lead to reduced well-being in both the child with DS and their caregivers. Mobile technologies (e.g., applications, sensors) are increasingly being used to promote healthy routines at home due to their high ecological validity and scalability. Problematically, there are few wellness apps designed specifically for the DS population. This high-risk/high-reward research application aims to (1) develop ThriveDS, a game-based wellness app for children and adolescents with DS (and their caregivers), and (2) conduct beta- testing of the ThriveDS mobile app to assess its feasibility, acceptability, and usability. Throughout the project, we will involve a group of stakeholders including individuals with DS to guide our research procedures and app development. Content modules, game elements and features for the ThriveDS app will be initially selected based on evidence review and theory-based behavioral change techniques, and finalized following a series of qualitative user research. Focus groups will be conducted with parents of children and adults with DS to understand the users’ needs/requirements from a wellness app and gather feedback on the features, format, and educational content of the Thrive-DS app. Then we will interview experts in relevant fields (e.g., nutrition, physical therapy, and occupational therapy), who will provide insights into key evidence-based mechanisms for DS-specific nutrition, physical activity, and sleep interventions, respectively. We will then employ directed content analysis to synthesize these findings, identify a priority list of elements for the application, and then develop the alpha version (first iteration) of the ThriveDS app. Next, the app will undergo usability testing (n=10) followed by the full development of the app (beta version). We expect that the ThriveDS mobile intervention will use a combination of educational modules/videos, game elements, and personalized, real-time brief intervention prompts based on data from wearable activity trackers (e.g., activity level, sleep patterns). In Aim 2, the app will undergo 3-month beta testing in a cohort of individuals DS (n=27). We will then assess its feasibility (recruitment, retention, usage statistics), acceptability (user satisfaction), and usability (ease of use) via app analytics and questionnaires. We will then interview caregivers (n=15) who participated in the beta testing, which will be analyzed to identify core facilitators and barriers to app usage. We anticipate that our next step will be an inclusive clinical trial in the DS population, addressing component 3 of the INCLUDE Research Plan. We plan to rapidly disseminate our findings and data, thus accelerating development of interventions for co-occurring disorders in DS. We will also disseminate our findings to the local and national DS communities via manuscripts and presentations. Project Number: 1R21HD118503-01 | Fiscal Year: 2025 | NIH Institute/Center: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator: Aaron Dallman (+1 co-PI) | Institution: RUTGERS BIOMEDICAL AND HEALTH SCIENCES, Newark, NJ | Award Amount: $431,750 | Activity Code: R21 | Study Section: Lifestyle Change and Behavioral Health Study Section[LCBH] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R21HD11850301