Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,432
- 试验地点
- 2
- 主要终点
- Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
研究概览
简要总结
The purpose of this study is to compare three methods for managing obesity in rural patients, to see which method will result in patients being able to attain their weight loss goal and maintain that weight loss.
详细描述
Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a higher rate from obesity and obesity-related illnesses, including diabetes, heart disease, and arthritis. Local primary care physicians are an important resource for treating obesity in rural areas because of a lack of other community resources.
This study is looking at how effective current, real-world primary care treatment models are in helping rural residents lose weight and maintain that weight loss. Physician clinics will be randomized (like picking numbers from a hat) to conduct one of the three methods. The method a participant is part of will depend on the method their physician's clinic is randomized to. The three methods involved in this study are:
- Individual weight-management counseling in person (in clinic individual visits)
- Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits)
- Group weight-management counseling by telephone (phone group visits)
Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 30 kg/m2 and 45 kg/m
- •Live in a rural location.
- •Have clearance from their primary care provider to participate in a diet and exercise weight control intervention.
- •Have access to a telephone.
- •One individual per household will be permitted to enroll in the study.
排除标准
- •History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months.
- •History of bariatric surgery or planning bariatric surgery in the next two years.
- •Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating.
- •Serious medical conditions where weight loss is contraindicated.
- •End stage renal disease or end stage liver disease.
- •Other medical contraindications as determined by the patient's primary care physician (PCP); documented PCP clearance will be obtained.
- •Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted.
- •Participants who plan to relocate outside of their provider's service area or who plan to leave their primary care clinic in the next 2 years.
- •Unable to read and understand English.
结局指标
主要结局
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
时间窗: Baseline and 6, 18 and 24 months
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Mean Weight Change Over 24 Months; Adjusted
时间窗: Baseline and 6, 18 and 24 months
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.
次要结局
- Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation(Baseline and 6, 18 and 24 months)
- Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation(Baseline and 6, 18 and 24 months)
- Mean Change in Fasting Glucose; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation(Baseline and 6, 18 and 24 months)
- Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation(Baseline and 6, 18 and 24 months)
- Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)
- Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation(Baseline and 6 and 24 months)