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

Part of paid clinical trials in Knoxville, Tennessee.

Sponsor
The University of Tennessee, Knoxville
Study ID
NCT07207993
Status
Not Yet Recruiting

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Conditions

  • AI-Based Fitness
  • Cognitive Decline
  • Older Adults
  • Older Adults With Cognitive Decline
  • Physical Activity
  • Physical Inactivity
  • Wearables

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Apr 1, 2028
Completion
Apr 1, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Access to all applications
    Condition 1: Participant are provided with the prescription application (application1), social application (application 2), and health tips application (application 3).
  • Experimental: Access to application 1 & 2
    Condition 2: Participant are provided with the prescription application, social application, but they aren't provided with the health tips application.
  • Experimental: Access to application 1 & 3
    Condition 3: Participant are provided with the prescription application, and they aren't provided with the social application, but they are provided with the health tips application.
  • Experimental: Access to application 1 only
    Condition 4: Participant are provided with the prescription application, but aren't provided with the social application, and the health tips application.
  • Experimental: Access to application 2 & 3
    Condition 5: Participant are not provided with the prescription application, but they are provided with the social application, and the health tips application.
  • Experimental: Access to application 2 only
    Condition 6: Participant are not provided with the prescription application, but they are provided with the social application, and they aren't provided with the health tips application.
  • Experimental: Access to application 3 only
    Condition 7: Participant are not provided with the prescription application, or the social application, but they are provided with the health tips application.
  • No Intervention: No access to any application
    Condition 8: Participant are not provided with the prescription application, or the social application, or with the health tips application.

Primary Outcome Measure

Fitbit MVPA [ Time Frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of TennesseeKnoxvilleTennessee37920
Kinesiology, Recreation, and Sport Studies
[email protected]
(865) 974-3340
Zan Gao, PhD (PRINCIPAL_INVESTIGATOR)
Danielle Ostendorf, PhD (SUB_INVESTIGATOR)
Xiaopeng Zhao, PhD (SUB_INVESTIGATOR)
Jeffrey Labban, PhD (SUB_INVESTIGATOR)

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