Bariatric Surgery and Guided Self-help for Binge Eating Disorder

N/ATerminatedNCT02094027

Imperial College London150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Obesity

Interventions

Guided Self HelpBEHAVIORAL

A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery

Treatment As UsualOTHER

Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

Change in body mass index point

Time frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up

Secondary Outcomes

Binge episodes

-Number of binge episodes per 28 days

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: pre-operatively, baseline, 3 month, 6 month and 1 year follow up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.