Clinical trial NCT02094027: Bariatric Surgery and Guided Self-help for Binge Eating Disorder
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Bariatric surgery
Binge eating
Self help
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-03-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index point
timeFrame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
Secondary outcomes:
measure: Binge episodes
timeFrame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
measure: Complication or reversal of surgery
timeFrame: 3 month, 6 month and 1 year follow up
measure: Quality of life
timeFrame: baseline, pre-operative, 3 month, 6 month and 1 year follow up
measure: Eating behaviour
timeFrame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
measure: Drug and alcohol misuse
timeFrame: pre-operatively, baseline, 3 month, 6 month and 1 year follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Samantha Scholtz, MRCPsych
role: PRINCIPAL_INVESTIGATOR
References: