An interventional study of Acceptance and Commitment Therapy-Based Physical Activity Intervention and Physical Activity Education Control in Obesity, sponsored by Hartford Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Hartford Hospital · Not applicable, Interventional, and Treatment
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:
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:
Nearly one in five U.S. adults have severe obesity (Body Mass Index ≥ 35 kg/m2), which is related to numerous comorbidities and reduced life expectancy. Metabolic bariatric surgery (MBS) reliably produces substantial, durable weight loss and health improvements for a majority of patients with severe obesity. However, weight regain over time is common and can develop into a serious complication marked by reemergence of comorbidities and impaired physical and mental quality of life. This issue is compounded by a lack of effective and accessible strategies to help MBS patients prevent weight regain and achieve lifelong success. Indeed, current post-surgical guidelines advise that patients increase moderate-to-vigorous intensity physical activity (MVPA) for weight loss maintenance and lifelong health, but most patients do not, and available interventions do not address their reported low internal drive to engage in regular MVPA. Acceptance and Commitment Therapy (ACT)-based interventions are effective at promoting health behavior changes via improved autonomous (or internal) motivation. ACT achieves this by clarifying personal values, linking behavioral performance to those values, and increasing acceptance of contrary thoughts and emotions that act as barriers to new behavior engagement. The investigators pilot-tested a one-time, group-based ACT-based workshop intervention (+ email feedback and support phone calls) to increase MVPA among low-active adults with obesity. Participants on average achieved and maintained clinically important increases in MVPA and autonomous motivation, and larger improvements in motivation were related to larger MVPA increases. These preliminary results show potential for this approach to help MBS patients boost autonomous motivation for achieving sustainable increases in MVPA. Further, this low-touch approach makes it ideal for reducing barriers to participation and future application in MBS and other clinical settings. The investigators will now build on these findings by testing whether targeting MBS patients' autonomous motivation with ACT-based intervention produces sustained increases in MVPA, and if such increases prevent weight regain after MBS. The investigators will randomize 164 patients who are 8-20 months post-MBS and show relative weight stability to 12 months of: ACT targeting autonomous motivation for MVPA; or contact-matched educational control (CON) providing PA-focused education and prescribed goals. Both groups will: (1) receive group-based workshops via Zoom video conferencing, email feedback and homework assignments, and individual telephone counseling calls; and (2) be assessed at pre- and 3, 6, 12, and 18-months post-randomization. The investigators will compare ACT and CON on changes in: 1) MVPA and weight regain (primary outcomes) and 2) autonomous motivation and acceptance (secondary outcomes). The investigators will also explore mediators of the treatment effect on MVPA (motivation, acceptance) and weight regain (MVPA). If successful, results could justify more robust physical activity guidelines and use of these strategies in clinical practice to help motivate MBS patients to achieve sustainable increases in MVPA for weight regain prevention.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 164 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.
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Exclusion Criteria:
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
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
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
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
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)
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)
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)
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)
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers with academic interest in topics such as physical activity interventions, metabolic bariatric surgery, and weight management. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisite to the sharing of data with the requesting party.
Supporting information: Study protocol, Statistical analysis plan
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).
Data sharing details ↗ · hartfordhealthcare.org
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