Loss of Control Eating Following Weight Loss Surgery

Loss of Control Eating Clinical Trial

Official title:

Treatment of Loss of Control Eating Following Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259322
• Other study ID #: 1205010224
• Secondary ID: R01DK098492-01A1
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2018

Study information

• Verified date: August 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Loss of Control Eating
• Weight Loss

Intervention

Behavioral:
• Standard-of-Care
Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
• Behavioral Weight Loss Treatment
Biweekly individual guided self-help sessions for 3 months
• Cognitive Behavioral Therapy
Biweekly individual guided self-help sessions for 3 months

Locations

Country	Name	City	State
United States	Yale Department of Psychiatry	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Body Mass Index (BMI)	BMI is calculated using measured height and weight.	Post-treatment (at 3 months)
Primary	Body Mass Index (BMI)	BMI is calculated using measured height and weight.	24 month follow-up (an average of 24 months following treatment)