Loss of Control Eating Following Weight Loss Surgery

Yale University

Status: Completed

Conditions: Loss of Control Eating

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Standard-of-Care; Behavioral: Behavioral Weight Loss Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02259322

1205010224

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

Details and patient eligibility

About

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.

Enrollment: 140 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 3 patient groups

Standard-of-Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard-of-Care

Behavioral Weight Loss Treatment

Experimental group

Description:

Guided self-help Behavioral Weight Loss Treatment

Treatment:

Behavioral: Behavioral Weight Loss Treatment

Cognitive Behavioral Therapy

Experimental group

Description:

Guided self-help Cognitive Behavioral Therapy

Treatment:

Behavioral: Cognitive Behavioral Therapy