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Loss of Control Eating Following Weight Loss Surgery

Primary Purpose

Loss of Control Eating

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard-of-Care

Behavioral Weight Loss Treatment

Cognitive Behavioral Therapy

About this trial

This is an interventional treatment trial for Loss of Control Eating focused on measuring Bariatric surgery, Weight loss surgery, Behavioral weight loss treatment, Cognitive behavioral therapy, Behavioral treatment, Obesity, Morbid obesity, Binge eating, Binge eating disorder, Loss of control eating, Overeating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Yale Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Standard-of-Care

Behavioral Weight Loss Treatment

Cognitive Behavioral Therapy

Arm Description

Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.

Guided self-help Behavioral Weight Loss Treatment

Guided self-help Cognitive Behavioral Therapy

Outcomes

Primary Outcome Measures

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).

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).

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).

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).

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Body Mass Index (BMI)

BMI is calculated using measured height and weight.

Secondary Outcome Measures

Full Information

NCT ID

NCT02259322

First Posted

September 29, 2014

Last Updated

August 11, 2022

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02259322

Brief Title

Loss of Control Eating Following Weight Loss Surgery

Official Title

Treatment of Loss of Control Eating Following Bariatric Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

July 2018 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Loss of Control Eating

Keywords

Bariatric surgery, Weight loss surgery, Behavioral weight loss treatment, Cognitive behavioral therapy, Behavioral treatment, Obesity, Morbid obesity, Binge eating, Binge eating disorder, Loss of control eating, Overeating

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard-of-Care

Arm Type

Active Comparator

Arm Description

Standard-of-care is the continuation of any treatment or recommendations participants receive from his/her bariatric surgeon/team.

Arm Title

Behavioral Weight Loss Treatment

Arm Type

Experimental

Arm Description

Guided self-help Behavioral Weight Loss Treatment

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

Guided self-help Cognitive Behavioral Therapy

Intervention Type

Behavioral

Intervention Name(s)

Standard-of-Care

Intervention Description

Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.

Intervention Type

Behavioral

Intervention Name(s)

Behavioral Weight Loss Treatment

Intervention Description

Biweekly individual guided self-help sessions for 3 months

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

Biweekly individual guided self-help sessions for 3 months

Primary Outcome Measure Information:

Title

Loss of Control Eating Frequency (Categorical)

Description

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).

Time Frame

Post-treatment (at 3 months)

Title

Loss of Control Eating Frequency (Categorical)

Description

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).

Time Frame

24 month follow-up (an average of 24 months following treatment)

Title

Loss of Control Eating Frequency (Continuous)

Description

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).

Time Frame

Post-treatment (at 3 months)

Title

Loss of Control Eating Frequency (Continuous)

Description

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).

Time Frame

24 month follow-up (an average of 24 months following treatment)

Title

Body Mass Index (BMI)

Description

BMI is calculated using measured height and weight.

Time Frame

Post-treatment (at 3 months)

Title

Body Mass Index (BMI)

Description

BMI is calculated using measured height and weight.

Time Frame

24 month follow-up (an average of 24 months following treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos M Grilo, Ph.D.

Organizational Affiliation

Yale University School of Medicine; Department of Psychiatry

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Department of Psychiatry

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31197602

Citation

Lawson JL, Wiedemann AA, Carr MM, Ivezaj V, Duffy AJ, Grilo CM. Examining Sleep Quality Following Sleeve Gastrectomy Among Patients with Loss-of-Control Eating. Obes Surg. 2019 Oct;29(10):3264-3270. doi: 10.1007/s11695-019-03981-7.

Results Reference

derived

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Loss of Control Eating Following Weight Loss Surgery

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