Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatr… (NCT06484621) | Clinical Trial Compass
RecruitingNot Applicable
Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
United States164 participantsStarted 2024-08-08
Plain-language summary
The goal of this clinical trial is to learn if a psychological intervention can increase regular physical activity to help prevent weight regain after metabolic bariatric surgery in adults. The main questions it aims to answer are:
1. Does the psychological intervention increase physical activity?
2. Does the psychological intervention prevent weight regain?
3. Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity?
Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery.
Participants will:
* Complete 12 months of either the psychological or educational intervention. This includes attending online workshops with a small group of participants, completing brief homework assignments, and having individual telephone calls with a counselor.
* Wear a device to measure physical activity, use an electronic scale to measure body weight, and complete questionnaires at home on five separate occasions over an 18-month period
Who can participate
Age range
18 Years – 64 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.
Inclusion Criteria:
* Having undergone either a primary Roux-en-Y gastric bypass or sleeve gastrectomy bariatric procedure between 6 and 20 months prior to enrollment
* Have reached their nadir weight and regained less than 10% of maximum weight lost based on weight measurements
* Had their surgery performed at Hartford Hospital or another surgical weight loss center within the Hartford HealthCare system.
* Able to provide consent
* Willing to engage in and complete the study protocol
* Able to safely participate in a physical activity program
Exclusion Criteria:
* Have regained 10% or more of maximum weight lost based on weight measurements
* Cannot ambulate independently
* Do not speak/read English at a 6th grade level
* Are pregnant, lactating, less than 6-months postpartum or plan to become pregnant during the course of the study
* Report current involvement in a weight management program outside of standard care
* Begin taking a newly prescribed medication for weight loss less than two months prior to study enrollment
* Begin taking a newly prescribed medication or change the dosage/frequency of pre-existing medications that are associated with weight loss/weight gain but not taken to produce weight loss less than two months prior to study enrollment
* Report any conditions or plans that would preclude adherence to the study protocol (i.e., plans to relocate, psychiatric problems such as substance use disorder, or terminal illness)
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
Moderate-to-Vigorous Physical Activity
Timeframe: From baseline to the end of treatment (at 12-months) and follow-up (at 18-months)
2
Amount (%) of weight regain
Timeframe: From baseline to end of treatment (at 12-months) and follow-up (at 18-months)