Modeling Effective Obesity Treatment to Reduce Disparities Through Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 261
- 试验地点
- 10
- 主要终点
- Change in body weight, as measured at months 0, 12, 24 (or at final visit).
研究概览
简要总结
Think Health! A Personal Weight Management Program, or "¡Vive Saludable! Un programa personalizado de control de peso" aims to improve the treatment of obesity in adults in the general population, by conducting research with men and women recruited from primary care medical practices. The study has a particular focus on African Americans and Latino. The design is randomized trial of the effectiveness of two versions of a lifestyle weight loss program called delivered by primary care providers (PCP) and ancillary staff at 5 clinical practice sites to their own patients. The two versions of the lifestyle weight loss program are called Basic (minimal counseling provided by PCP every four months) and Basic Plus (same PCP counseling plus additional counseling by specially trained ancillary practice staff acting as Lifestyle Coaches (LC), monthly for the first 12 months and then every other month for up to 2 years).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men
- •Ages 18 to 70 years
- •Body mass index > 25 kg/m2 but < 55 kg/m2 or who weigh <400 pounds.
排除标准
- •Pregnancy or lactation, since contraindicated for weight loss or affecting weight status
- •Weight loss > 10 pounds in the previous 3 months
- •Current use of weight loss medications
- •Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics)
- •Psychiatric disorders including untreated major depression, psychosis, bulimia nervosa, and substance abuse
- •Active chemo- or radiation therapy
- •Unstable renal, hepatic, or cardiovascular disease, including malignant arrhythmias
- •Recent (past 3 months) history of myocardial infarction, stroke, or congestive heart failure
- •Participants age < 18 will be excluded because we are only using adult practices and a different type of program would be needed for patients < 18, and age > 70 years will be excluded because our experience has been that a specially tailored program would be needed. As a design consideration, we wanted to decrease the heterogeneity of the program.
- •Participants with a BMI > 55 kg/m2 will be excluded because they are likely to require more extensive medical and behavioral care than can be provided in this study.
- •More than 1 participant residing in the same household will be excluded to avoid contamination across the treatment conditions.
- •Final exclusion criteria will be determined in collaboration with participating primary care providers
结局指标
主要结局
Change in body weight, as measured at months 0, 12, 24 (or at final visit).
时间窗: Up to 24 months
次要结局
- Blood pressure, height, and waist measurements; surveys to assess health behavior changes; and attendance at treatment visits.(Up to 24 months)