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Loss of Control Eating Following Weight Loss Surgery

Treatment of Loss of Control Eating Following Bariatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02259322
Enrollment
140
Registered
2014-10-08
Start date
2014-09-30
Completion date
2018-07-31
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALStandard-of-Care

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

Biweekly individual guided self-help sessions for 3 months

BEHAVIORALCognitive Behavioral Therapy

Biweekly individual guided self-help sessions for 3 months

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Loss of Control Eating Frequency (Categorical)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).
Loss of Control Eating Frequency (Continuous)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).
Body Mass Index (BMI)Post-treatment (at 3 months)BMI is calculated using measured height and weight.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026