NCT06484621 Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery
| NCT ID | NCT06484621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hartford Hospital |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-08-08 |
| Primary Completion | 2028-09-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-08-08 with a primary completion date of 2028-09-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility 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)
Contact & Investigator
Dale S Bond, PhD
PRINCIPAL INVESTIGATOR
Hartford Hospital
Frequently Asked Questions
Who can join the NCT06484621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06484621 currently recruiting?
Yes, NCT06484621 is actively recruiting participants. Contact the research team at Anna.Schwartz@hhchealth.org for enrollment information.
Where is the NCT06484621 trial being conducted?
This trial is being conducted at Hartford, United States.
Who is sponsoring the NCT06484621 clinical trial?
NCT06484621 is sponsored by Hartford Hospital. The principal investigator is Dale S Bond, PhD at Hartford Hospital. The trial plans to enroll 164 participants.
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