The Fit With Us Study
NCT06207084 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257
Last updated 2026-01-09
Summary
The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.
Conditions
- Usability
- Mobility Limitations
- Disability Physical
- Telehealth
- Health Coaching
- Physical Activity
- Behavior, Health
- eHealth
- Health Literacy
- Self Efficacy
- Fatigue
- Predictive Model
Interventions
- BEHAVIORAL
-
Asynchronous content and health coaching and no live training
Receives asynchronous content, health coaching and no live training.
- BEHAVIORAL
-
asynchronous content only and 1 on 1 live training
receives asynchronous content and live 1 on 1 training
- BEHAVIORAL
-
asynchronous content and health coaching and 1 on 1 training
receives asynchronous content, health coaching, and live training
- BEHAVIORAL
-
asynchronous content and group training
receives asynchronous content and live group training
- BEHAVIORAL
-
Asynchronous content and health coaching and group training
receives asynchronous content, health coaching, and live group training
- BEHAVIORAL
-
asynchronous content only
Receives asynchronous exercise content and no live training
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Mohanraj Thirumalai, PhD · University of Alabama at Birmingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 89 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2028-02-01
- Completion
- 2029-02-01
Countries
- United States
Study Locations
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