Status:
RECRUITING
Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief 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 q...
Detailed Description
Nearly one in five U.S. adults have severe obesity (Body Mass Index ≥ 35 kg/m2), which is related to numerous comorbidities and reduced life expectancy. Metabolic bariatric surgery (MBS) reliably prod...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06484621
Start Date
August 8 2024
End Date
December 31 2028
Last Update
October 15 2025
Active Locations (1)
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1
Hartford HealthCare
Hartford, Connecticut, United States, 06102