RecruitingNot Applicable

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

United States64 participantsStarted 2026-06-08

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant must be at least 65 years of age older * Participant must be living alone in the U.S. for the next 6 months * Participant must have report mild cognitive decline \[We will use a short self-report AD8 measure of cognitive concerns. Those scoring positive on the AD8 (≥2) will qualify as mild cognitive decline\]; * Participant must own an Android/Apple smartphone * Participant must have access to internet or Wi-Fi access * Participant must be capable of engaging in some PA as determined by the PA Readiness Questionnaire or physician approval * Participant must currently participate in weekly moderate-to-vigorous PA (MVPA) or less than 150 minutes * Participant must have basic English communication skills. Exclusion Criteria: * Foreign residents or visitors

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fitbit MVPA

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).

Physical Activity

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).

Mechanism of behavior change (MoBC) variables

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).

Trial details

NCT IDNCT07207993

SponsorThe University of Tennessee, Knoxville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-08

Contact for this trial

Zan Gao, PhD

865-974-7971 zan@utk.edu

View on ClinicalTrials.gov More Older Adults With Cognitive Decline trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fitbit MVPA

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).

Physical Activity

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).

Mechanism of behavior change (MoBC) variables

Timeframe: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).