← Back to Search

Behavioural Intervention

Behavioral Intervention for Post-Bariatric Surgery Weight Regain

N/A

Recruiting

Research Sponsored by Temple University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months (assessment points at baseline, 3 month, 6 month, 12 month)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness of a remote intervention program for individuals who have undergone bariatric surgery and are experiencing weight regain. The trial will compare the outcomes of those who receive the intervention program

Who is the study for?

This trial is for individuals who have had bariatric surgery, are experiencing weight regain of more than 5% after the sixth postoperative month, and want to try a remotely-delivered behavioral treatment. It's not suitable for those who don't meet these specific conditions.

What is being tested?

The study tests an acceptance-based behavioral intervention (ABTi) against standard post-surgery advice in controlling weight regain over 12 months. Participants will be randomly placed into two groups: one receiving ABTi and the other receiving regular dietary and behavior guidance calls.

What are the potential side effects?

Since this trial involves behavioral interventions rather than medication, side effects may include emotional discomfort or stress due to changes in eating habits or lifestyle adjustments required by the program.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months (assessment points at baseline, 3 month, 6 month, 12 month)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months (assessment points at baseline, 3 month, 6 month, 12 month)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (assessment points at baseline, 3 month, 6 month, 12 month) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Weight

Secondary study objectives

Caloric Intake

Eating Behavior - Cognitive Constraint

Eating Behavior - Disinhibition

+6 more

Other study objectives

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

Mechanisms of Action (Exploratory) - Anxiety

Mechanisms of Action (Exploratory) - Defusion

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Acceptance-Based Behavioral InterventionExperimental Treatment1 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.

Group II: ControlActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acceptance-Based Behavioral Intervention

2014

N/A

~20

Do I qualify?Apply below to find out