What this study is
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.
What's being tested
- Fitness app for self-efficacy
Intervention · OTHER
AI-driven personalized exercise prescription via a fitness app. This targets self-efficacy.
- Social network via app for social support
Intervention · OTHER
Participants will be provided access to a social network via app. This targets social support.
- Health education app targeting outcome expectations
Intervention · OTHER
Participants are provided with an app-based health education. This targets outcome expectations.
Study details
- Sponsor
- The University of Tennessee, Knoxville
- Conditions
- Older Adults With Cognitive Decline · Older Adults · AI-Based Fitness · Wearables · Cognitive Decline · Physical Activity · Physical Inactivity
- Enrolling
- 64 people
- Starts
- 2026-06-08
- Est. completion
- 2028-06-08
- Design
- Double-blind, randomized, factorial
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- Foreign residents or visitors
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUniversity of Tennessee
Knoxville, Tennessee, United States
- Kinesiology, Recreation, and Sport Studies · Contact(865) 974-3340krss@utk.edu
- Zan Gao, PhD · Principal investigator
- Danielle Ostendorf, PhD · Sub-investigator
- Xiaopeng Zhao, PhD · Sub-investigator
- Jeffrey Labban, PhD · Sub-investigator
Not yet recruitingThe University of Tennessee, Knoxville. Health, Recreation, and Physical Education Building
Knoxville, Tennessee, United States
Recruiting
Study team
Sponsor
The University of Tennessee, Knoxville
Study ID STUDY00000016
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.