Bariatric Surgery and Guided Self-help for Binge Eating Disorder

Obesity Clinical Trial

— BED  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02094027
• Other study ID #: 10/H0707/67
• Status: Terminated
• Phase: N/A
• First received: March 5, 2014
• Last updated: December 16, 2016
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Feeding and Eating Disorders
• Obesity

Intervention

Behavioral:
• Guided Self Help
A behaviourally orientated guided self help book designed to reduce binge eating prior to 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)

Locations

Country	Name	City	State
United Kingdom	Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body mass index point		baseline, pre-operatively, 3 month, 6 month and 1 year follow up	No
Secondary	Binge episodes	-Number of binge episodes per 28 days	baseline, pre-operatively, 3 month, 6 month and 1 year follow up	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No