Motivating Increases in Physical Activity for Prevention of Weight Regain After Metabolic Bariatric Surgery

ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHartford Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Acceptance and Commitment Therapy-Based Physical Activity 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

    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.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Acceptance and Commitment Therapy-Based Physical Activity InterventionExperimental treatment 1 intervention
Group B: Physical Activity Education InterventionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Moderate-to-Vigorous Physical Activity

Change in daily minutes of MVPA: total (in \>=1-minute bouts) and bouted (in \>=10-min bouts)

Time frame
From baseline to the end of treatment (at 12-months) and follow-up (at 18-months)
2

Amount (%) of weight regain

The percentage of weight that is regained from baseline

Time frame
From baseline to end of treatment (at 12-months) and follow-up (at 18-months)

Secondary outcomes

1

Autonomous motivation

Relative Autonomy Index Score measured via the Exercise Self-Regulation Questionnaire

Time frame
From baseline to end of treatment (at 12 months) and follow-up (at 18 months)
2

Physical Activity Acceptance

Total Physical Activity Acceptance Questionnaire Score

Time frame
From baseline to end of treatment (at 12-months) and follow-up (at 18-months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hartford Hospital

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator