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New evidence came to light to indicate that study was no longer relevant
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Self Help | Experimental | Guided Self Help intervention to reduce binge eating |
|
| Treatment As Usual | Placebo Comparator | No intervention for binge eating (treatment as usual in the form of bariatric surgery) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Self Help | Behavioral | A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body mass index point | baseline, pre-operatively, 3 month, 6 month and 1 year follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Binge episodes | -Number of binge episodes per 28 days | baseline, pre-operatively, 3 month, 6 month and 1 year follow up |
| Complication or reversal of surgery | Surgical complication or reversal of bariatric surgery as per case notes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Scholtz, MRCPsych | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obesity, Endocrine and Medical Clinics at Imperial College Healthcare NHS Trust | London | W6 8RF | United Kingdom |
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.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D002032 | Bulimia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment As Usual | Other | Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating) |
|
| 3 month, 6 month and 1 year follow up |
| Quality of life | Score on SF-36, IQoL-lite, Hospital anxiety and depression scale (HADS), and PANAS (positive and negative affect scale) | baseline, pre-operative, 3 month, 6 month and 1 year follow up |
| Eating behaviour | 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) | baseline, pre-operatively, 3 month, 6 month and 1 year follow up |
| Drug and alcohol misuse | As measured by AUDIT drug and alcohol assessment tool | pre-operatively, baseline, 3 month, 6 month and 1 year follow up |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |