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

NCT07207993 | Not Yet Recruiting

• 1 other identifier: UTK IRB-25-09047-XP
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Older adults; Cognitive decline; AI-Based Fitness; Physical Activity; Physical Inactivity; Living alone with cognitive decline; LACD; U.S Older adults

Outcome Measures

Primary Outcomes (3)

• Fitbit MVPA

  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).

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

• Physical Activity

  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)

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

• Mechanism of behavior change (MoBC) variables

  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.

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

Secondary Outcomes (3)

• Quality of life (QoL)

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

• Psychosocial wellbeing

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

• Cognition

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

Study Arms (8)

Access to all applications

EXPERIMENTAL

Condition 1: Participant are provided with the prescription application (application1), social application (application 2), and health tips application (application 3).

Other: Fitness app for self-efficacy; Other: Social network via app for social support; Other: Health education app targeting outcome expectations

Access to application 1 & 2

EXPERIMENTAL

Condition 2: Participant are provided with the prescription application, social application, but they aren't provided with the health tips application.

Other: Fitness app for self-efficacy; Other: Social network via app for social support

Access to application 1 & 3

EXPERIMENTAL

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.

Other: Fitness app for self-efficacy; Other: Health education app targeting outcome expectations

Access to application 1 only

EXPERIMENTAL

Condition 4: Participant are provided with the prescription application, but aren't provided with the social application, and the health tips application.

Other: Fitness app for self-efficacy

Access to application 2 & 3

EXPERIMENTAL

Condition 5: Participant are not provided with the prescription application, but they are provided with the social application, and the health tips application.

Other: Social network via app for social support; Other: Health education app targeting outcome expectations

Access to application 2 only

EXPERIMENTAL

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.

Other: Social network via app for social support

Access to application 3 only

EXPERIMENTAL

Condition 7: Participant are not provided with the prescription application, or the social application, but they are provided with the health tips application.

Other: Health education app targeting outcome expectations

No access to any application

NO INTERVENTION

Condition 8: Participant are not provided with the prescription application, or the social application, or with the health tips application.

Interventions

Fitness app for self-efficacy OTHER

AI-driven personalized exercise prescription via a fitness app. This targets self-efficacy.

Access to all applications; Access to application 1 & 2; Access to application 1 & 3; Access to application 1 only

Social network via app for social support OTHER

Participants will be provided access to a social network via app. This targets social support.

Access to all applications; Access to application 1 & 2; Access to application 2 & 3; Access to application 2 only

Health education app targeting outcome expectations OTHER

Participants are provided with an app-based health education. This targets outcome expectations.

Access to all applications; Access to application 1 & 3; Access to application 2 & 3; Access to application 3 only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You 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 may not qualify if:

• Foreign residents or visitors

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead
• Arizona State University: collaborator
• Oregon Research Institute: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Tennessee

Knoxville, Tennessee, 37920, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Zan Gao, PhD

CONTACT

865-974-7971; zan@utk.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The design is blinded, with all investigators except the biostatistician unaware of group and intervention assignments.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: October 6, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)