What this study is
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
What's being tested
- Acceptance and Commitment Therapy-Based Physical Activity Intervention
Intervention · BEHAVIORAL
Provides experiential training in values-clarification and acceptance strategies to increase autonomous motivation for achieving self-determined physical activity goal via group-based workshops, email feedback, and brief support calls.
- Physical Activity Education Control
Intervention · BEHAVIORAL
Provides didactic instruction on physical activity and behavioral strategies for achieving prescribed physical activity goals via group-based workshops, email feedback, and brief support calls.
Study details
- Official title
- 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
- Sponsor
- Hartford Hospital
- Conditions
- Obesity
- Enrolling
- 164 people
- Starts
- 2024-08-08
- Est. completion
- 2028-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 64 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHartford HealthCare
Hartford, Connecticut, United States
- Clinical research coordinator · Contact
- Dale S Bond, PhD · Principal investigator
Recruiting
Study team
Sponsor
Hartford Hospital
Study ID 037604
Principal investigator
Dale S Bond, PhD
Hartford Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.