NCT00471172已完成不适用
A 6-Month, Randomized Study To Evaluate The Efficacy Of Various Non-Pharmacologic, Disease Management Programs For The Treatment Of Obesity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- Percentage change in body weight at 6 months.
研究概览
简要总结
The aim of the study was to compare 5 methods of delivering a weight loss lifestyle modification program to obese patients on a background of sibutramine. The methods differed in the type and frequency of counseling utilized to deliver dietary, physical activity and behavioral recommendations for weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Body mass index -calculated as weight in kilograms divided by the square of height in meters- ≥30 and <40 kg/m
- •2- Eligibility to be prescribed sibutramine, following the eligibility requirements listed in the US Package Insert
- •3- Willingness and ability to comply with study related procedures
- •4- Access to Internet and email
排除标准
- •Uncontrolled blood pressure (defined as ≥140/90 mmHg), diabetes, coronary heart disease, chronic congestive heart failure, stroke, significant metabolic, hepatic or renal disease, current malignancy, gastric bypass surgery or had a weight loss ≥10%, participated in a structured weight loss program, or had taken weight loss agents during the past 6 months. Women were excluded if pregnant or breastfeeding; women of childbearing potential had to use adequate contraception.
结局指标
主要结局
Percentage change in body weight at 6 months.
次要结局
- Changes in waist circumference, lipids, glucose, insulin, blood pressure, quality of life and weight-related symptoms at 6 months.
研究者
研究点 (12)
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