Treatment of Binge Eating in Obese Patients in Primary Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- BMI
研究概览
简要总结
This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese (BMI >= 30)
排除标准
- •Medication regimen that represents medical contraindication to sibutramine
- •Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
- •Pregnancy
研究组 & 干预措施
Sibutramine
Sibutramine 15 mg daily
干预措施: Sibutramine (Drug)
Placebo
Placebo Daily
干预措施: Placebo (Drug)
Placebo/CBTsh
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
干预措施: Self-help CBT + Sibutramine (Behavioral)
Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
干预措施: Self-help CBT + Placebo (Behavioral)
结局指标
主要结局
BMI
时间窗: 4 months
BMI (kg/m\^2) was measured 4 months after treatment.
Binge Eating (Remission)
时间窗: 4 months treatment; 6 and 12 month follow up post treatment
Remission from binge eating (zero binge episodes during previous 28 days)
次要结局
未报告次要终点
研究者
Carlos Grilo
Professor of Psychiatry
Yale University