Recruiting

mHealth Intervention

Sponsor:

The University of Tennessee, Knoxville

Code:

NCT07207993

Conditions

Older Adults With Cognitive Decline

Older Adults

AI-Based Fitness

Wearables

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Fitness app for self-efficacy

Social network via app for social support

Health education app targeting outcome expectations

Study Details

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 With Cognitive Decline

Older Adults

AI-Based Fitness

Wearables

Cognitive Decline

Study ID

NCT07207993

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Jun 8, 2028

Anticipated

Primary completion date

Jun 8, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Fitness app for self-efficacy

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

Social network via app for social support

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

Health education app targeting outcome expectations

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

Primary outcome measure

  • Fitbit MVPA [ Time Frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point). ]
  • Physical Activity [ Time Frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point). ]
  • Mechanism of behavior change (MoBC) variables [ Time Frame: Baseline (i.e., pre-intervention), 3 months (mid-point), and 6 months (end-point). ]

Central Contacts and Locations

Central contacts

Zan Gao, PhD

865-974-7971zan@utk.edu

Locations

The University of Tennessee, Knoxville. Health, Recreation, and Physical Education Building

Recruiting

Knoxville, Tennessee, United States, 37996

More Information

Sponsor

The University of Tennessee, Knoxville

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Tennessee, Knoxville on 2026-06-15.