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Trial record 60 of 592 for:    binge eating disorder

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

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ClinicalTrials.gov Identifier: NCT02094027
Recruitment Status : Terminated (New evidence came to light to indicate that study was no longer relevant)
First Posted : March 21, 2014
Last Update Posted : December 19, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Obesity Behavioral: Guided Self Help Other: Treatment As Usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guided Self Help
Guided Self Help intervention to reduce binge eating
Behavioral: Guided Self Help
A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery

Placebo Comparator: Treatment As Usual
No intervention for binge eating (treatment as usual in the form of bariatric surgery)
Other: Treatment 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)




Primary Outcome Measures :
  1. Change in body mass index point [ Time Frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up ]

Secondary Outcome Measures :
  1. Binge episodes [ Time Frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up ]
    -Number of binge episodes per 28 days

  2. Complication or reversal of surgery [ Time Frame: 3 month, 6 month and 1 year follow up ]
    Surgical complication or reversal of bariatric surgery as per case notes

  3. Quality of life [ Time Frame: 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)

  4. Eating behaviour [ Time Frame: 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)

  5. Drug and alcohol misuse [ Time Frame: pre-operatively, baseline, 3 month, 6 month and 1 year follow up ]
    As measured by AUDIT drug and alcohol assessment tool



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094027


Locations
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United Kingdom
Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Samantha Scholtz, MRCPsych Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02094027     History of Changes
Other Study ID Numbers: 10/H0707/67
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD has been shared with Prof. Alex Blakemore as planned, who was conducting the genetic part of the study and who is using the data in wider analysis.

Keywords provided by Imperial College London:
Obesity
Bariatric surgery
Binge eating
Self help

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms