Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
Recruiting · NCT06484621 · Interventional (participants receive a specific treatment) · Lead sponsor: Hartford Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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)
Where it is running
1 location listed across 1 US state.
- Hartford HealthCare - Hartford, Connecticut, United States