Bariatric Surgery and Guided Self-help for Binge Eating Disorder (BED)

The Role of Self-help in the Pre-surgical Treatment of Binge Eating Disorder in Bariatric Surgery Candidates: Implications for Weight-related and Psychological Outcome.

To demonstrate the effectiveness of an easily administered intervention (guided self help) aimed at reducing binge eating in patients undergoing bariatric surgery.

The investigators hypothesize that patients who have guided self help pre-operatively will have reduced episodes of bingeing pre-operatively compared to those having treatment as usual (bariatric surgery), which will be maintained in the post-operative period, and will be associated with improved weight loss and psychological outcomes after surgery.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Guided Self Help; Other: Treatment As Usual

Detailed Description

Binge eating disorder (BED) is distressing and common in patients who present for treatment for obesity. Despite this, it is often undiagnosed. Patients who have bariatric surgery have improvements in their eating patterns, including binge eating. However there is variability in the degree of weight loss and post-operative complications following bariatric surgery, associated with disordered eating.

Guided self help for BED (GSH) is a treatment which, like bariatric surgery, is effective in reducing the number of binge episodes in people who binge eat. It is not known whether GSH prior to surgery, in patients undergoing bariatric surgery has any additional benefit for reducing bingeing, or improving weight loss in these patients.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obese (BMI >28 kg/m2)
• Pursuing bariatric surgery

Exclusion Criteria:

• Any illnesses which make the patient unsuitable
• If the patient is taking any medication which makes them unsuitable
• If the patient is pregnant or breast feeding
• If the patient has donated blood in the last three months
• If the patient has a history of alcoholism or substance dependency within the last 5 years
• If the patient has a history of major haematological, renal, gastrointestinal, hepatic, respiratory, cardiovascular or psychiatric disease or other illness or use of any medications, including over the counter products, which, in the opinion of the investigators would either interfere with the study or potentially cause harm to the volunteer
• If the patient has any medical or psychological condition or social circumstances which would interfere with their ability to participate reliably in the trial
• If the patient is without access to a telephone
• If the patient is currently receiving or intends to receive treatment with an investigational drug within the next 2 months If the patient is currently receiving or intends to receive treatment for binge eating
• If the patient currently suffers with severe depression, as indicated by a Beck Depression Inventory Score greater than 28

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Self Help; Guided Self Help intervention to reduce binge eating	Behavioral: Guided Self Help; A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery
Placebo Comparator: Treatment As Usual; No intervention for binge eating (treatment as usual in the form of bariatric surgery)	Other: Treatment As Usual; Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body mass index point	baseline, pre-operatively, 3 month, 6 month and 1 year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binge episodes	-Number of binge episodes per 28 days	baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Complication or reversal of surgery	Surgical complication or reversal of bariatric surgery as per case notes	3 month, 6 month and 1 year follow up
Quality of life	Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale)	baseline, pre-operative, 3 month, 6 month and 1 year follow up
Eating behaviour	Emotional, externally driven, disinhibited, restrained eating patterns and weight and shape concerns as measured by Eating disorders examination questionnaire (EDE-Q), Dutch Eating Behaviour Questionnaire (DEBQ), Three factor eating questionnaire (TFEQ)	baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Drug and alcohol misuse	As measured by AUDIT drug and alcohol assessment tool	pre-operatively, baseline, 3 month, 6 month and 1 year follow up

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Samantha Scholtz, MRCPsych, Imperial College London

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 19, 2014
• First Posted (Estimate): March 21, 2014

Study Record Updates

• Last Update Posted (Estimate): December 19, 2016
• Last Update Submitted That Met QC Criteria: December 16, 2016
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Obesity; Bariatric surgery; Binge eating; Self help
• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Hyperphagia; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
• Other Study ID Numbers: 10/H0707/67

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The IPD has been shared with Prof. Alex Blakemore as planned, who was conducting the genetic part of the study and who is using the data in wider analysis.