The Fit With Us Study (NCT06207084) | Clinical Trial Compass
RecruitingNot Applicable
The Fit With Us Study
United States257 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Physical activity
Timeframe: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32