Loss of Control Eating Following Weight Loss Surgery

August 11, 2022 updated by: Yale University

Treatment of Loss of Control Eating Following Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: Post-treatment (at 3 months)
BMI is calculated using measured height and weight.
Post-treatment (at 3 months)
Loss of Control Eating Frequency (Categorical)
Time Frame: Post-treatment (at 3 months)
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)
Time Frame: 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).
24 month follow-up (an average of 24 months following treatment)
Loss of Control Eating Frequency (Continuous)
Time Frame: Post-treatment (at 3 months)
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)
Time Frame: 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).
24 month follow-up (an average of 24 months following treatment)
Body Mass Index (BMI)
Time Frame: 24 month follow-up (an average of 24 months following treatment)
BMI is calculated using measured height and weight.
24 month follow-up (an average of 24 months following treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Carlos M Grilo, Ph.D., Yale University School of Medicine; Department of Psychiatry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

September 29, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205010224
  • R01DK098492-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Loss of Control Eating

Clinical Trials on Standard-of-Care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe