NCT07207993 · The University of Tennessee, Knoxville
Evaluating Health Outcomes of AI-Based Fitness Wearables and App Programs in Older Adults Living Alone With Cognitive Decline
What this study is about
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).
View original scientific description
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.
Interventions
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.
Primary outcome measures
Fitbit MVPA
Time frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).
Fitbit Inspire 3 Tracker will be used to assess participants' MVPA (active time which includes both fairly active time and very active time). Fairly active; duration associated with light intensity activities, i.e., walking, light cycling, housework (\~3-6 METs). Very active; duration associated with high intensity activities, i.e., running, aerobic workouts (\>6 METs).
Physical Activity
Time frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).
We will use the Physical Activity Scale for the Elderly to assess PA. Higher scores means more physical activity. (Low activity: \<100; Moderate: 100-250; High: \>250)
Mechanism of behavior change (MoBC) variables
Time frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point).
Psychometrically validated questionnaires will be used to assess beliefs: self-efficacy, social support, and outcome expectations. Self-efficacy; low score indicates low confidence in ability to perform behavior, high score indicates strong confidence. Social support; low score indicates poor support from family or friends, high score indicates great support. Outcome expectation; low score indicates the belief that behavior won't help, high score indicates the belief that the behavior will lead to positive outcome.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Knoxville, Tennessee
Collaborators
Arizona State University, Oregon Research Institute, National Institute on Aging (NIA)
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations