Recruiting

Physical Activity

Sponsor:

Hartford Hospital

Code:

NCT06484621

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Acceptance and Commitment Therapy-Based Physical Activity Intervention

Physical Activity Education Control

Study Details

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

Conditions

Obesity

Study ID

NCT06484621

Start date

Aug 8, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acceptance and Commitment Therapy-Based Physical Activity Intervention

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.

active comparator: Physical Activity Education Intervention

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.

Interventions

Acceptance and Commitment Therapy-Based Physical Activity Intervention

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

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.

Primary outcome measure

  • Moderate-to-Vigorous Physical Activity [ Time Frame: From baseline to the end of treatment (at 12-months) and follow-up (at 18-months) ]
  • Amount (%) of weight regain [ Time Frame: From baseline to end of treatment (at 12-months) and follow-up (at 18-months) ]

Central Contacts and Locations

Central contacts

Chloe David, B.S.

860-972-5750Chloe.David@hhchealth.org

Locations

Hartford HealthCare

Recruiting

Hartford, Connecticut, United States, 06102

Principal Investigator:

Dale S Bond, PhD

More Information

Sponsor

Hartford Hospital

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • bariatric surgery
  • weight regain
  • physical activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2026-08-06.