Loss of Control Eating Following Weight Loss Surgery

NCT02259322 | Completed

• 2 other identifiers: 1205010224R01DK098492-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:

1. 1.Behavioral Weight Loss Treatment
2. 2.Cognitive Behavioral Therapy

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• Body Mass Index (BMI)

  BMI is calculated using measured height and weight.

  Post-treatment (at 3 months)

• Body Mass Index (BMI)

  BMI is calculated using measured height and weight.

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

Study Arms (3)

Standard-of-Care

ACTIVE COMPARATOR

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

Behavioral: Standard-of-Care

Behavioral Weight Loss Treatment

EXPERIMENTAL

Guided self-help Behavioral Weight Loss Treatment

Behavioral: Behavioral Weight Loss Treatment

Cognitive Behavioral Therapy

EXPERIMENTAL

Guided self-help Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Standard-of-Care BEHAVIORAL

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

Standard-of-Care

Behavioral Weight Loss Treatment BEHAVIORAL

Biweekly individual guided self-help sessions for 3 months

Behavioral Weight Loss Treatment

Cognitive Behavioral Therapy BEHAVIORAL

Biweekly individual guided self-help sessions for 3 months

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale Department of Psychiatry

New Haven, Connecticut, 06510, United States

Location

Related Publications (1)

• 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.

  PMID: 31197602 DERIVED

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Bulimia; Binge-Eating Disorder; Hyperphagia

Interventions

Standard of Care; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Carlos M Grilo, Ph.D.

  Yale University School of Medicine, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 8, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 15, 2022

Record last verified: 2022-08

Locations

US (1)