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

NCT06484621 | Recruiting

• 2 other identifiers: 0376041R01DK135463-01A1
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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:

• 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

Conditions

Obesity

Keywords

bariatric surgery; weight regain; physical activity

Outcome Measures

Primary Outcomes (2)

• Moderate-to-Vigorous Physical Activity

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

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

• Amount (%) of weight regain

  The percentage of weight that is regained from baseline

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

Secondary Outcomes (2)

• Autonomous motivation

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

• Physical Activity Acceptance

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

Study Arms (2)

Acceptance and Commitment Therapy-Based Physical Activity Intervention

EXPERIMENTAL

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.

Behavioral: Acceptance and Commitment Therapy-Based Physical Activity Intervention

Physical Activity Education Intervention

ACTIVE COMPARATOR

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.

Behavioral: Physical Activity Education Control

Interventions

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.

Also known as: Intervention

Acceptance and Commitment Therapy-Based Physical Activity Intervention

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.

Also known as: Control

Physical Activity Education Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You 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 may not qualify 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)

Sponsors & Collaborators

• Hartford Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Hartford HealthCare

Hartford, Connecticut, 06102, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dale S Bond, PhD

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna S Schwartz, MPH

CONTACT

860-972-3194; Anna.Schwartz@hhchealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): September 28, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible up to 24 months.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)