Loss of Control Eating Following Weight Loss Surgery

Study Overview
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Brief Summary
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This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery: Behavioral Weight Loss Treatment Cognitive Behavioral Therapy These treatments will be compared to Standard-of-Care.

Official Title
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Treatment of Loss of Control Eating Following Bariatric Surgery

Conditions
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Loss of Control Eating

Intervention / Treatment
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* Behavioral: Standard-of-Care
* Behavioral: Behavioral Weight Loss Treatment
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program 5-8 months post-bariatric surgery Regular loss of control eating (once weekly during past month) Read English proficiently enough to read patient self-care materials and study assessments Available for duration of treatment plus follow-up period Agree to study procedures Exclusion Criteria: Current enrollment in a formal exercise program Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability) Unable to ambulate Current medications that influence eating/weight Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard-of-Care<br>Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team. | Behavioral: Standard-of-Care<br>* Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.<br>|
| Experimental: Behavioral Weight Loss Treatment<br>Guided self-help Behavioral Weight Loss Treatment | Behavioral: Behavioral Weight Loss Treatment<br>* Biweekly individual guided self-help sessions for 3 months<br>|
| Experimental: Cognitive Behavioral Therapy<br>Guided self-help Cognitive Behavioral Therapy | Behavioral: Cognitive Behavioral Therapy<br>* Biweekly individual guided self-help sessions for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of Control Eating Frequency (Categorical) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating). | Post-treatment (at 3 months) | 
| Loss of Control Eating Frequency (Categorical) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating). | 24 month follow-up (an average of 24 months following treatment) | 
| Loss of Control Eating Frequency (Continuous) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | Post-treatment (at 3 months) | 
| Loss of Control Eating Frequency (Continuous) | Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally). | 24 month follow-up (an average of 24 months following treatment) | 
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | Post-treatment (at 3 months) | 
| Body Mass Index (BMI) | BMI is calculated using measured height and weight. | 24 month follow-up (an average of 24 months following treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric surgery, Weight loss surgery, Behavioral weight loss treatment, Cognitive behavioral therapy, Behavioral treatment, Morbid obesity, Binge eating, Binge eating disorder, Loss of control eating, Overeating