Bariatric Surgery and Guided Self-help for Binge Eating Disorder

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Guided Self Help
* Other: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Binge eating, Obesity, Bariatric surgery, Self help