NCT07207993 Evaluating Health Outcomes of AI-Based Fitness Wearables and App Programs in Older Adults Living Alone With Cognitive Decline
| NCT ID | NCT07207993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Tennessee, Knoxville |
| Condition | Older Adults With Cognitive Decline |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2026-06-08 |
| Primary Completion | 2028-06-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2026-06-08 with a primary completion date of 2028-06-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07207993 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Older Adults With Cognitive Decline. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207993 currently recruiting?
Yes, NCT07207993 is actively recruiting participants. Contact the research team at zan@utk.edu for enrollment information.
Where is the NCT07207993 trial being conducted?
This trial is being conducted at Knoxville, United States, Knoxville, United States.
Who is sponsoring the NCT07207993 clinical trial?
NCT07207993 is sponsored by The University of Tennessee, Knoxville. The trial plans to enroll 64 participants.