Increasing Physical Activity to Prevent Weight Regain After Bariatric Surgery
Using Acceptance and Commitment Therapy to Promote Autonomous Motivation for Increased Physical Activity and Improved Weight Loss Maintenance in Bariatric Surgery Patients: A Randomized Trial
This study is testing whether a new psychological program can help people who had weight loss surgery stay active and avoid gaining weight back.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Hartford Hospital Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT06484621 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if a psychological intervention can enhance physical activity levels and prevent weight regain in adults who have undergone metabolic bariatric surgery. Participants will be assigned to either an Acceptance and Commitment Therapy (ACT)-based intervention or an educational control group, engaging in online workshops, homework assignments, and individual support calls over 12 months. The study will assess the effectiveness of the psychological approach in fostering internal motivation for physical activity and managing the discomfort associated with it. By comparing the two interventions, researchers hope to identify a more effective strategy for long-term weight maintenance post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone Roux-en-Y gastric bypass or sleeve gastrectomy within the last 8 to 20 months and have not regained more than 10% of their maximum weight lost.
Not a fit: Patients who have regained 10% or more of their maximum weight lost or cannot ambulate independently may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the ability of bariatric surgery patients to maintain their weight loss and enhance their overall health and quality of life.
How similar studies have performed: Previous studies utilizing Acceptance and Commitment Therapy have shown promise in promoting health behavior changes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hartford, Connecticut
- Hartford HealthCare — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Dale S Bond, PhD — Hartford Hospital
- Study coordinator: Anna S Schwartz, MPH
- Email: Anna.Schwartz@hhchealth.org
- Phone: 860-972-3194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.