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
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|
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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)
- Change in body mass index point [ Time Frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up ]
- Binge episodes [ Time Frame: baseline, pre-operatively, 3 month, 6 month and 1 year follow up ]-Number of binge episodes per 28 days
- 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
- 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)
- 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)
- 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
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
|Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Samantha Scholtz, MRCPsych||Imperial College London|