Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Reached Binge Eating Remission
研究概览
简要总结
This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.
详细描述
The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Standard Care
干预措施: Behavioral Weight Loss (Behavioral)
2
Stepped-care
干预措施: Behavioral Weight Loss (Behavioral)
2
Stepped-care
干预措施: Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy (Behavioral)
2
Stepped-care
干预措施: Placebo (Drug)
2
Stepped-care
干预措施: Sibutramine/Orlistat (Drug)
结局指标
主要结局
Number of Subjects Who Reached Binge Eating Remission
时间窗: 12 months follow-up
Binge Remission (abstinence from binge eating)
次要结局
- BMI(12 months follow-up post-treatment)