Evaluating Health Outcomes of AI-Based Fitness Wearables and App Programs in Older Adults Living Alone With Cognitive Decline

The overarching goal of our research is to develop personalized and accessible healthy aging lifestyle interventions aimed at promoting physical activity (PA) and improving health among community-dwelling older adults living alone with cognitive decline (LACD). To achieve this goal, the purpose of this project is to determine whether wearable and app-based mHealth intervention component(s) will contribute to increased PA and improved health outcomes in older adults LACD. Our specific aims are to: identify and evaluate mHealth intervention components that practically and significantly contribute to enhanced mechanistic outcomes (e.g., self-efficacy, outcome expectations) and increased PA (primary outcome) in older adults LACD over a 6-month period; determine the optimal combinations of intervention components for future efficacy testing; elucidate the mechanism of behavioral change (MoBC) and potential outcomes of these intervention components, namely, the mediating effects of MoBC variables (e.g., self-efficacy, outcome expectations) on the relationship between intervention components and change in PA. The first two aims are primary and fully-powered. The third aim is exploratory. The aims will support a refined, data-driven intervention design for a subsequent larger trial.

NCT Number	NCT07207993
Lead Sponsor	The University of Tennessee, Knoxville Collaborators: Arizona State University, Oregon Research Institute, National Institute on Aging (NIA)
Conditions	Older Adults With Cognitive Decline, Older Adults, AI-Based Fitness, Wearables, Cognitive Decline, Physical Activity, Physical Inactivity
Enrollment	64 participants
Start Date	2026-06-08
Primary Completion	2028-06-08 (estimated)
Study Completion	2028-06-08 (estimated)
Updated on ClinicalTrials.gov	2026-06-15