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Bariatric Surgery and Guided Self-help for Binge Eating Disorder (BED)

Imperial College London logo

Imperial College London

Status

Terminated

Conditions

Obesity

Treatments

Other: Treatment As Usual
Behavioral: Guided Self Help

Study type

Interventional

Funder types

Other

Identifiers

NCT02094027
10/H0707/67

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups, including a placebo group

Guided Self Help
Experimental group
Description:
Guided Self Help intervention to reduce binge eating
Treatment:
Behavioral: Guided Self Help
Treatment As Usual
Placebo Comparator group
Description:
No intervention for binge eating (treatment as usual in the form of bariatric surgery)
Treatment:
Other: Treatment As Usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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