RemI for Post-Bariatric Surgery Weight Regain

Temple University

Status: Enrolling

Conditions: Bariatric Surgery Candidate; Obesity

Treatments: Behavioral: Acceptance-Based Behavioral Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06292936

30692

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Acceptance-Based Behavioral Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Acceptance-Based Behavioral Intervention

Control

No Intervention group

Description:

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.