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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in body mass index point
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese (BMI >28 kg/m2)
- •Pursuing bariatric surgery
排除标准
- •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
结局指标
主要结局
Change in body mass index point
时间窗: baseline, pre-operatively, 3 month, 6 month and 1 year follow up
次要结局
- Complication or reversal of surgery(3 month, 6 month and 1 year follow up)
- Quality of life(baseline, pre-operative, 3 month, 6 month and 1 year follow up)
- Drug and alcohol misuse(pre-operatively, baseline, 3 month, 6 month and 1 year follow up)
- Binge episodes(baseline, pre-operatively, 3 month, 6 month and 1 year follow up)
- Eating behaviour(baseline, pre-operatively, 3 month, 6 month and 1 year follow up)