Skip to main content
OpenTrials
Completed

NCT Number: NCT02259322

Loss of Control Eating Following Weight Loss 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Loss of Control Eating Binge-Eating Disorder Body Weight Bulimia Feeding and Eating Disorders Hyperphagia Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard-of-Care

Behavioral

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

Behavioral Weight Loss Treatment

Behavioral

Biweekly individual guided self-help sessions for 3 months

Cognitive behavioral therapy

Behavioral

Biweekly individual guided self-help sessions for 3 months

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. Body Mass Index (BMI)

    Time frame: Post-treatment (at 3 months)

    BMI is calculated using measured height and weight.

  6. 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

Treatment of Loss of Control Eating Following Bariatric Surgery

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 8, 2014
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.