Primary Care Obesity Management in the Southeast_PROMISE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 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
研究组 & 干预措施
Self-directed treatment
Participants randomly assigned to this arm will receive written and pre-recorded behavioral weight loss intervention materials (i.e., DVDs, online videos), and they will be instructed to work through the materials independently at their own pace. They will have continued physician contact as needed for routine medical care.
干预措施: weight loss intervention - self directed (Behavioral)
Peer coach treatment
Participants randomly assigned to this arm will receive a combination of in-person, group-based behavioral weight loss sessions plus individual, telephone contacts. Groups and phone calls will be facilitated by a peer coach interventionist. Similar to the self-directed condition, participants will receive written and pre-recorded intervention materials (i.e., DVDs, online videos). They will also have continued contact with their physician for routine medical care.
干预措施: weight loss intervention - peer coach (Behavioral)
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