Trials / Not Yet Recruiting

Not Yet RecruitingNCT07207993

Evaluating Health Outcomes of AI-Based Fitness Wearables & App Programs in Elderly With Cognitive Decline

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 64 (estimated)

Sponsor: The University of Tennessee, Knoxville · Academic / Other
Sex: All
Age: 65 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

Mobile health (mHealth) is a promising approach to improving health behaviors, defined as "health services and information delivered or enhanced through the Internet and related technologies." It includes disease prevention and management tools, remote interventions, personalized health monitoring, and mobile healthcare data access. With widespread technology adoption, researchers increasingly use wearable devices and apps to enhance health outcomes by promoting PA and reducing sedentary behavior. Wearable devices and fitness apps are now widely integrated into PA intervention programs, helping individuals adopt more active lifestyles. These tools track steps, activity duration, and progress, providing real-time feedback, goal-setting, and social integration to enhance motivation and behavior regulation. Notably, 21% of U.S. adults regularly use smartwatches or fitness trackers, making them feasible for PA interventions in older adults. RCTs have shown their positive effects on PA, QoL, and psychosocial well-being in older adults though some studies reported modest improvements. Recent advancements in data science and AI-driven mHealth interventions enable scalable, personalized exercise prescriptions. Personalized approaches, particularly those enhancing self-efficacy, yield better outcomes than generalized interventions. However, few studies have leveraged fitness wearables and apps for older adult LACD. This trial addresses this major weakness by implementing an AI-driven mHealth intervention for tailored precision health programs in older adult LACD.

Conditions

Interventions

Type	Name	Description
OTHER	Fitness app for self-efficacy	AI-driven personalized exercise prescription via a fitness app. This targets self-efficacy.
OTHER	Social network via app for social support	Participants will be provided access to a social network via app. This targets social support.
OTHER	Health education app targeting outcome expectations	Participants are provided with an app-based health education. This targets outcome expectations.

Timeline

Start date: 2026-04-01
Primary completion: 2028-04-01
Completion: 2028-04-01
First posted: 2025-10-06
Last updated: 2026-02-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07207993. Inclusion in this directory is not an endorsement.