Treatment of Loss of Control Eating Following Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
This study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery:
- Behavioral Weight Loss Treatment
- Cognitive Behavioral Therapy
These treatments will be compared to Standard-of-Care.
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
- 否
入选标准
- •Gastric bypass surgery or sleeve gastrectomy patients from Yale Bariatric/Gastrointestinal Surgery Program
- •5-8 months post-bariatric surgery
- •Regular loss of control eating (once weekly during past month)
- •Read English proficiently enough to read patient self-care materials and study assessments
- •Available for duration of treatment plus follow-up period
- •Agree to study procedures
排除标准
- •Current enrollment in a formal exercise program
- •Medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability)
- •Unable to ambulate
- •Current medications that influence eating/weight
- •Current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 24 month follow-up (an average of 24 months following treatment)
BMI is calculated using measured height and weight.
Loss of Control Eating Frequency (Categorical)
时间窗: 24 month follow-up (an average of 24 months following treatment)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency is defined categorically (presence or absence of loss of control eating).
Loss of Control Eating Frequency (Continuous)
时间窗: 24 month follow-up (an average of 24 months following treatment)
Loss of Control eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).
次要结局
未报告次要终点