NCT06207084 · University of Alabama at Birmingham
The Fit With Us Study
(FITWITHUS)
What this study is about
The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
asynchronous content only
Receives asynchronous exercise content and no live training
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
Primary outcome measures
Physical activity
Time frame: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Birmingham, Alabama
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2026 · Source of record for eligibility and locations