NCT02959021已完成不适用
Primary Care Obesity Management in the Southeast_PROMISE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
The purpose of this study is to examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-75 years
- •Body mass index (BMI) 30-50 kg/m2
- •Receiving primary care services at one of the practices participating in this study
排除标准
- •Uncontrolled hypertension (blood pressure >160/100 mm Hg at screening)
- •Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity
- •Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months)
- •Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site
- •Likely to relocate out of the area in the next 2 years
- •Participation in another randomized research project
- •Weight loss > 10 pounds in past six months
- •History of bariatric surgery
结局指标
主要结局
body weight
时间窗: 6, 12, and 18 months
change in body weight (kg) from baseline to follow-up assessments
次要结局
- treatment adherence(6, 12, and 18 months)
- quality of life(6, 12, and 18 months)
- treatment burden(6, 12, and 18 months)
- healthcare utilization(6, 12, and 18 months)
- side effects(6, 12, and 18 months)
- physical and social functioning(6, 12, and 18 months)
- physical activity(6, 12, and 18 months)
- treatment satisfaction(6, 12, and 18 months)
- mood(6, 12, and 18 months)
研究者
Gareth R. Dutton PhD
Associate Professor of Medicine
University of Alabama at Birmingham
研究点 (2)
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