The Fit With Us Study

NCT06207084 | Recruiting DMC

• 2 other identifiers: IRB-30001176290REGE0019
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

telehealth; health coaching; disability

Outcome Measures

Primary Outcomes (1)

• Physical activity

  The primary outcome is the change in physical activity (steps per day) from baseline to the end of the 32-week intervention. Participants wear Fitbit Inspire 3 trackers (Google LLC, Sacramento, CA) for continuous objective measurement, with data exported via the study dashboard. This is supplemented by the Godin Leisure-Time Exercise Questionnaire (GLETQ) at baseline, week-8 and week-16 for self-reported leisure-time activity in MET-minutes/week.

  Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32

Secondary Outcomes (3)

• Health information technology literacy

  Baseline, week 8, week 16, and week 32

• Secondary Health Conditions

  Baseline, week 8, week 16, and week 32

• Activity limitations

  Baseline, week 8, week 16, and week 32

Study Arms (6)

asynchronous exercise responder

EXPERIMENTAL

Individuals only receiving asynchronous exercise content and are responding

Behavioral: asynchronous content only

Asynchronous exercise and health coaching responder

EXPERIMENTAL

Individuals receiving asynchronous exercise content and health coaching and are responding

Behavioral: Asynchronous content and health coaching and no live training

Asynchronous exercise non-responder and 1 on 1 live training

EXPERIMENTAL

Individuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions.

Behavioral: asynchronous content only and 1 on 1 live training

Asynchronous exercise and health coaching non-responder and 1 on 1 live training

EXPERIMENTAL

Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions.

Behavioral: asynchronous content and health coaching and 1 on 1 training

Asynchronous exercise non-responder and group live training

EXPERIMENTAL

Individuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions.

Behavioral: asynchronous content and group training

Asynchronous exercise and health coaching non-responder and group live training

EXPERIMENTAL

Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions.

Behavioral: Asynchronous content and health coaching and group training

Interventions

asynchronous content only and 1 on 1 live training BEHAVIORAL

receives asynchronous content and live 1 on 1 training

Asynchronous exercise non-responder and 1 on 1 live training

asynchronous content and health coaching and 1 on 1 training BEHAVIORAL

receives asynchronous content, health coaching, and live training

Asynchronous exercise and health coaching non-responder and 1 on 1 live training

Asynchronous content and health coaching and group training BEHAVIORAL

receives asynchronous content, health coaching, and live group training

Asynchronous exercise and health coaching non-responder and group live training

asynchronous content and group training BEHAVIORAL

receives asynchronous content and live group training

Asynchronous exercise non-responder and group live training

asynchronous content only BEHAVIORAL

Receives asynchronous exercise content and no live training

asynchronous exercise responder

Asynchronous content and health coaching and no live training BEHAVIORAL

Receives asynchronous content, health coaching and no live training.

Asynchronous exercise and health coaching responder

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Eligible participants must meet the following criteria to be included: (1) live with a permanent physical disability that limits their mobility; (2) be 18 to 89 years of age; (3) have broadband internet access; (4) be able to speak and read English; and (5) be able to attend coaching and training sessions during the weekdays. Participants are excluded from participation if they (1) possess significant visual acuity that prevents seeing a computer screen to follow a home exercise program; (2) have been regularly engaging in exercise for the previous 3 months; (3) are unable to use their arms and their legs at all to exercise; (4) are unsafe to exercise; (5) self-report that they are currently pregnant

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Wellness, Health and Research Facility

Birmingham, Alabama, 35209, United States

RECRUITING

Related Links

• Intervention landing page.

MeSH Terms

Conditions

Mobility Limitation; Motor Activity; Health Behavior; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Mohanraj Thirumalai, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohanraj Thirumalai, PhD

CONTACT

205-934-7189; mohanraj@uab.edu

Sangeetha Mohanraj, MS

CONTACT

205-975-0550; sangee@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Sequential Multiple Assignment Randomization Model

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 16, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)