The Fit With Us Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06207084
Status
Recruiting
Apply to this trial

Conditions

  • Behavior, Health
  • Disability Physical
  • Fatigue
  • Health Coaching
  • Health Literacy
  • Mobility Limitations
  • Physical Activity
  • Predictive Model
  • Self Efficacy
  • Telehealth
  • Usability
  • eHealth

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • asynchronous content only — BEHAVIORAL
    Receives asynchronous exercise content and no live training
  • Asynchronous content and health coaching and no live training — BEHAVIORAL
    Receives asynchronous content, health coaching and no live training.
  • asynchronous content only and 1 on 1 live training — BEHAVIORAL
    receives asynchronous content and live 1 on 1 training
  • asynchronous content and health coaching and 1 on 1 training — BEHAVIORAL
    receives asynchronous content, health coaching, and live training
  • asynchronous content and group training — BEHAVIORAL
    receives asynchronous content and live group training
  • Asynchronous content and health coaching and group training — BEHAVIORAL
    receives asynchronous content, health coaching, and live group training

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Jan 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
257 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: asynchronous exercise responder
    Individuals only receiving asynchronous exercise content and are responding
  • Experimental: Asynchronous exercise and health coaching responder
    Individuals receiving asynchronous exercise content and health coaching and are responding
  • Experimental: Asynchronous exercise non-responder and 1 on 1 live training
    Individuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions.
  • Experimental: Asynchronous exercise and health coaching non-responder and 1 on 1 live training
    Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions.
  • Experimental: Asynchronous exercise non-responder and group live training
    Individuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions.
  • Experimental: Asynchronous exercise and health coaching non-responder and group live training
    Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions.

Primary Outcome Measure

Physical activity [ Time Frame: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wellness, Health and Research FacilityBirminghamAlabama35209
Ayse G Zengul, PhD
[email protected]
659 2733627
Mohanraj Thirumalai, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Wellness, Health and Research Facility· Birmingham, AL

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