Hartford HealthCare
Hartford, Connecticut, 06102, United States
Location status: Recruiting
Location contact
Clinical research coordinator
CONTACT
Dale S Bond, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06484621
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
Interested in participating?
Request Info18 year–64 year
All sexes
Interventional
Not applicable
Hartford, Connecticut, 06102, United States
Location status: Recruiting
Clinical research coordinator
CONTACT
Dale S Bond, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Other names: 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.
Other names: Control
Time frame: From baseline to the end of treatment (at 12-months) and follow-up (at 18-months)
Change in daily minutes of MVPA: total (in >=1-minute bouts) and bouted (in >=10-min bouts)
Time frame: From baseline to end of treatment (at 12-months) and follow-up (at 18-months)
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)
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)
Total Physical Activity Acceptance Questionnaire Score
Contact information is provided by the study sponsor or research team.
Hartford Hospital
Other
Using Acceptance and Commitment Therapy to Promote Autonomous Motivation for Increased Physical Activity and Improved Weight Loss Maintenance in Bariatric Surgery Patients: A Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06619041
Behavior, Body Weight
Aurora, Colorado, United States
View Trial DetailsNCT06397729
Behavior, Body Weight
St Louis, Missouri, United States
View Trial DetailsNCT06364644
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial DetailsNCT05880108
Behavior, Body Weight
Baltimore, Maryland, United States
View Trial Details