RemI for Post-Bariatric Surgery Weight Regain

Not Applicable

Recruiting

• Conditions: Obesity; Bariatric Surgery Candidate
• Interventions: Behavioral: Acceptance-Based Behavioral Intervention

• Registration Number: NCT06292936
• Lead Sponsor: Temple University

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. 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. 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Study Start: 2024-04-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-15
• Primary Completion: 2027-12-31
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Men and women
• Ages 18-70 years old
• Weight regain of at least 5% from lowest postoperative weight
• 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

Exclusion Criteria

• Long-term treatment with oral steroids
• Current use of weight loss medication (OTC or prescription)
• Current pregnancy or plan to become pregnant within 12 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acceptance-Based Behavioral Intervention	Acceptance-Based Behavioral Intervention	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.

Primary Outcome Measures

Name	Time	Method
Weight	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	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.

Secondary Outcome Measures

Name	Time	Method
Eating Behavior - Cognitive Constraint	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger.; The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually").; It is difficult to quantify a better or worse outcome here. Typically, higher scores in the cognitive constraint item, indicate greater conscious control over eating behavior.
Physical Activity	12 Months Overall (intervals of 7 days at baseline, 3 Month, 6 Month, 12 Month)	Objectively measured physical activity outcomes will be minutes of moderate to vigorous physical activity accumulated overall and in bouts of 10 minutes or longer as assessed by the activPAL. The activPAL is a wireless multi-sensor monitor worn on the thigh. This technology has been shown to accurately measure time engaged in physical activity intensity categories. Participants will wear the activPAL for 7 days at all assessment points.
Eating Behavior - Disinhibition	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger.; The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually").; It is difficult to quantify a better or worse outcome here. Typically, higher scores in Disinhibition signify a greater tendency to overeat or lose control over eating behavior.
Eating Behavior - Hunger	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Eating Behavior will be measured via The Eating Inventory, which measures three factors related to eating behavior: 1) cognitive restraint, 2) disinhibition, and 3) hunger.; The Eating Inventory (also known as the three factor eating questionnaire) is separated into two parts. The first part consists of 36 questions and the second part consists of 15 questions. Part 1 allocates one point for each item (1-36). One point is given for each item on the Likert scale for Part 2 (i.e., 1 point given for "rarely" and three points given for "usually").; It is difficult to quantify a better or worse outcome here. Typically, a higher score in Hunger indicates greater subjective feelings of hunger and appetite.
Weight-Related Medical Comorbidities - Number of participants with hypercholesterolemia	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Hypercholesterolemia will be measured by participants undergoing a blood draw to evaluate cholesterol levels and triglycerides (after a 12 hour fast).
Caloric Intake	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Caloric intake will be measured via the Automated Self Administered 24-hour Dietary Assessment Tool (ASA-24), which is a public-access, freely available (through the National Cancer Institute), web-based tool to obtain high-quality dietary intake data with minimal bias.
Weight-Related Medical Comorbidities - Number of participants with hypertension	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Hypertension will be measured by participants undergoing a blood pressure check via blood pressure cuff.
Weight-Related Medical Comorbidities - Number of participants with diabetes	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Diabetes will be measured by participants undergoing a blood draw to evaluate blood glucose and HbA1c (after a 12 hour fast).
Weight-Related Medical Comorbidities - Number of participants with hyperlipidemia	12 Months (Assessment points at baseline, 3 Month, 6 Month, 12 Month)	Hyperlipidemia will be measured by participants undergoing a blood draw to evaluate cholesterol levels and triglycerides (after a 12 hour fast).

Trial Locations

Locations (2)

Rush University; 🇺🇸 Chicago, Illinois, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States