Evaluating Health Outcomes of AI-Based Fitness Wearables and App Programs in Older Adults Living Alone With Cognitive Decline

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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age65+

SponsorThe University of Tennessee, Knoxville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Foreign residents or visitors

Trial design

Design model

Factorial

Treatments tested in this trial

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

Treatment groups

64 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: Access to all applicationsExperimental treatment 3 interventions

Group B: Access to application 1 & 2Experimental treatment 2 interventions

Group C: Access to application 1 & 3Experimental treatment 2 interventions

Group D: Access to application 1 onlyExperimental treatment 1 intervention

Group E: Access to application 2 & 3Experimental treatment 2 interventions

Group F: Access to application 2 onlyExperimental treatment 1 intervention

Group G: Access to application 3 onlyExperimental treatment 1 intervention

Group H: No access to any applicationNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame