Bariatric Surgery and Guided Self-help for Binge Eating Disorder

Not Applicable

Terminated

• Conditions: Obesity
• Interventions: Other: Treatment As Usual; Behavioral: Guided Self Help

• Registration Number: NCT02094027
• Lead Sponsor: Imperial College London

Brief 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-07
• Status Verified: 2014-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-19
• Study First Posted: 2014-03-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2016-12-16
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment As Usual	Treatment As Usual	No intervention for binge eating (treatment as usual in the form of bariatric surgery)
Guided Self Help	Guided Self Help	Guided Self Help intervention to reduce binge eating

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Complication or reversal of surgery	3 month, 6 month and 1 year follow up	Surgical complication or reversal of bariatric surgery as per case notes
Quality of life	baseline, pre-operative, 3 month, 6 month and 1 year follow up	Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale)
Drug and alcohol misuse	pre-operatively, baseline, 3 month, 6 month and 1 year follow up	As measured by AUDIT drug and alcohol assessment tool
Binge episodes	baseline, pre-operatively, 3 month, 6 month and 1 year follow up	-Number of binge episodes per 28 days
Eating behaviour	baseline, pre-operatively, 3 month, 6 month and 1 year follow up	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)

Trial Locations

Locations (1)

Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom