Effectiveness of Brief Counseling for Weight Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- 2. Changes in body mass index (BMI) at 6, 12 and 24 months.
研究概览
简要总结
The purpose of this study is to test the effectiveness of three different methods for delivering weight management information. Two methods utilize an obesity drug and the third method utilizes brief behavioral counseling sessions only.
详细描述
There is a growing demand for effective obesity treatments that don't require much time to implement especially in a primary health-care setting where time is especially limited. Brief interventions that might provide benefits similar to those produced by more time-intensive and costly lifestyle interventions would be very useful. There is also increasing interest in the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and 24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention alone or in combination with a drug already approved for the long-term management of obesity (orlisat)and compare both interventions to a drug alone condition.
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
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index of 30 to 40
- •Male or females ages of 25 to 55 years
- •Normal blood pressure or controlled with medicine
- •Females not lactating, able to get pregnant or using acceptable birth control
- •Current allowed medications prescribed at least 2 months prior to study
排除标准
- •Pregnant, planning to get pregnant or becomes pregnant
- •Insulin dependent diabetes
- •Uncontrolled hypertension
- •Prescence or history of significant medical conditions that could impact the outcome of the study
- •Prescence of active gastrointestinal disorders
- •History of mental disorders including eating disorders
- •Weight loss greater than 10 pounds in the last 3 months
- •History of alcohol or drug dependency
- •Use of any weight-loss medication in the last 6 months
- •Known allery to orlistat or any of its components
结局指标
主要结局
2. Changes in body mass index (BMI) at 6, 12 and 24 months.
1. Changes in body weight at 6, 12 and 24 months.
次要结局
- 1. Changes in blood pressure at 6, 12 and 24 months.
- 2. Changes in lipids at 6, 12 and 24 months.
- 3. Changes in serum glucose at 6, 12 and 24 months.