RemI for Post-Bariatric Surgery Weight Regain

NCT06292936 | Recruiting DMC

• 1 other identifier: 30692
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). The main research aims are:

1. 1.To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control.
2. 2.To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups.
3. 3.Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

Conditions

Obesity; Bariatric Surgery Candidate

Keywords

Acceptance-Based Behavioral Therapy; Postoperative Outcomes; Weight Regain

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight will be measured with a digital scale with participants dressed in light clothes and without shoes. Percent weight loss will be calculated from participants' current weight (at each assessment point) as compared to their baseline weight. Weight will be measured in lbs.

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

Secondary Outcomes (9)

• Caloric Intake

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Eating Behavior - Cognitive Constraint

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Eating Behavior - Disinhibition

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Eating Behavior - Hunger

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Physical Activity

  12 Months Overall (intervals of 7 days at baseline, 3 Month, 6 Month, 12 Month)

Other Outcomes (8)

• Mechanisms of Action (Exploratory) - Acceptance of food-related internal experiences

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Mechanisms of Action (Exploratory) - Mindfulness

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

• Mechanisms of Action (Exploratory) - Defusion

  12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)

Study Arms (2)

Acceptance-Based Behavioral Intervention

EXPERIMENTAL

Participants assigned to ABTi will receive a remotely delivered intervention consisting of 20 modules over 6 months. Based on theory derived from acceptance and mindfulness approaches, the intervention provides psychological strategies to facilitate engagement in weight control behaviors. Each module includes a video presentation of material synchronized with a slideshow illustrating session material, interactive features, quizzes that will ensure participants have mastered the material, and directed assignments to be completed throughout the week. Participants will be assigned to view each module, self-monitor their daily food intake, and weigh themselves weekly. At the completion of each module, a brief call with a coach will be scheduled to discuss and clarify the content of the session, review homework, and provide feedback on food records and weekly weights.

Behavioral: Acceptance-Based Behavioral Intervention

Control

NO INTERVENTION

Participants assigned to the Control condition will receive telephone contacts from the coaches on the same schedule as those who receive ABTi. The content will focus on the (re) delivery of the dietary and behavioral instruction that patients received prior to bariatric surgery. For example, participants will be reminded to consume reduced portion sizes, avoid foods higher in sugar and fat, and eat discrete meals throughout the day. They will receive a Wi-Fi scale and will be asked to weigh themselves weekly, similar to those receiving ABTi.

Interventions

Acceptance-Based Behavioral Intervention BEHAVIORAL

Intervention will evaluate acceptance-based behavioral treatment (ABT) for individuals who are experiencing weight regain after bariatric surgery. ABT builds acceptance and mindfulness skills that increase the capacity to experience uncomfortable internal states (e.g., food cravings, hunger, negative affect). Online treatments include video modules demonstrating session content as well as interactive features. These interventions are particularly desirable, reduced participant burden, and are cost effective. ABT provides patients unique skills that directly target causes of dietary non-adherence. ABT provides patients specialized skills to directly target causes of dietary nonadherence (rather that solely repeating behavioral strategies they received during preoperative medical weight management required by their third party payers and bariatric surgery programs).

Acceptance-Based Behavioral Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women
• Ages 18-70 years old
• Weight regain of at least 5% from lowest postoperative weight
• Body mass index (BMI) 25 or above
• Underwent gastric bypass or sleeve gastrectomy within 6 to 48 months prior to enrollment
• Ability to give consent
• Ability to speak, write, and understand English

You may not qualify if:

• Long-term treatment with oral steroids
• Current use of weight loss medication (OTC or prescription)
• Current pregnancy, plan to become pregnant within 12 months, lactation within the past 6 months
• Psychiatric hospitalization in the past 6 months
• Documented or self-reported psychiatric diagnosis that would interfere with adherence to the study protocol or acute suicidality
• Self-report of alcohol or substance abuse within the past 12 months
• Current, self-reported use of tobacco products
• Weight loss \> 10 lbs in the past 3 month
• History of more than one bariatric procedure
• Inability to walk at least one city block without assistance

Sponsors & Collaborators

• Temple University: lead
• Rush University: collaborator

Study Sites (2)

Rush University

Chicago, Illinois, 60612, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

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Related Links

• The Drexel defusion scale
• Eating Inventory Manual
• ASA24

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• David B Sarwer, PhD

  Temple University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David B Sarwer, PhD

CONTACT

215-707-8632; dsarwer@temple.edu

Sarah R Fischbach, MPH

CONTACT

215-707-8633; sarah.fischbach@temple.edu

Study Design

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

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 5, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)