About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy-Based Physical Activity Intervention
BehavioralProvides 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
BehavioralProvides didactic instruction on physical activity and behavioral strategies for achieving prescribed physical activity goals via group-based workshops, email feedback, and brief support calls.
Treatment groups
Trial outcomes
Primary outcomes
Moderate-to-Vigorous Physical Activity
Change in daily minutes of MVPA: total (in \>=1-minute bouts) and bouted (in \>=10-min bouts)
Amount (%) of weight regain
The percentage of weight that is regained from baseline
Secondary outcomes
Autonomous motivation
Relative Autonomy Index Score measured via the Exercise Self-Regulation Questionnaire
Physical Activity Acceptance
Total Physical Activity Acceptance Questionnaire Score
Sponsors and contacts
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Hartford Hospital
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator