Loss of Control Eating Following Weight Loss Surgery

Not Applicable

Completed

• Conditions: Loss of Control Eating
• Interventions: Behavioral: Standard-of-Care; Behavioral: Behavioral Weight Loss Treatment; Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT02259322
• Lead Sponsor: Yale University

Brief Summary

This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:

1. Behavioral Weight Loss Treatment

2. Cognitive Behavioral Therapy

These treatments will be compared to Standard-of-Care.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-29
• Study First Submitted QC: 2014-10-03
• Study First Posted: 2014-10-08
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard-of-Care	Standard-of-Care	Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.
Behavioral Weight Loss Treatment	Behavioral Weight Loss Treatment	Guided self-help Behavioral Weight Loss Treatment
Cognitive Behavioral Therapy	Cognitive Behavioral Therapy	Guided self-help Cognitive Behavioral Therapy

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	24 month follow-up (an average of 24 months following treatment)	BMI is calculated using measured height and weight.
Loss of Control Eating Frequency (Categorical)	24 month follow-up (an average of 24 months following treatment)	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).
Loss of Control Eating Frequency (Continuous)	24 month follow-up (an average of 24 months following treatment)	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).

Trial Locations

Locations (1)

Yale Department of Psychiatry; 🇺🇸 New Haven, Connecticut, United States