Obesity
Conditions
Keywords
Obesity, Bariatric surgery, Binge eating, Self help
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.
Interventions
BEHAVIORALGuided Self Help
A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery
OTHERTreatment 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)
Sponsors
National Institute for Health Research, United Kingdom
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body mass index point | baseline, pre-operatively, 3 month, 6 month and 1 year follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge episodes | baseline, pre-operatively, 3 month, 6 month and 1 year follow up | -Number of binge episodes per 28 days |
| 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) |
| 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) |
| 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 |
Countries
United Kingdom
Outcome results
None listed