Weight Management in Rural Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Mean Weight Change Over 6 Months
研究概览
简要总结
The goal of this study is to evaluate the effect of three weight management interventions (group phone conference calls, individual phone calls, and enhanced usual care) on weight across 18 months in overweight and obese adults recruited through and treated by rural primary care clinics.
详细描述
The rates of overweight/obesity are significantly higher among residents of rural areas compared to their urban counterparts. Recent focus to provide whole-person health care suggests that rural primary care clinics may provide an ideal setting for delivery of weight management.
This study is a 3 group randomized trial to evaluate intervention delivery. The investigators will randomize 200 overweight/obese adult residents of rural towns (town population < 50,000) who obtain health care at primary care clinics to one of three groups for an 18 month trial (6 month weight loss; 12 month weight maintenance).
Group 1) Group phone (GP)/Portion-Controlled Meals (PCM)
Group 2) Individual phone (IP)/PCM
Group 3) Enhanced usual care (EUC)/Conventional Diet (CD)
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index 25 to 45 kg/m2
- •Clearance from primary care physician
排除标准
- •Unable to participate in moderate intensity physical activity
- •Participation in weight loss or physical activity program in previous 6 months
- •Greater than 3, 30-min bouts of planned exercise/week
- •Not weight stable (+/-4.6 kg) for 3 months prior to intake
- •Unwilling to be randomized to 1 of the 3 study groups
- •Report being pregnant during the previous 6 months or planned pregnancy in the following 18 months
- •Serious medical risk such as cancer, recent cardiac event
- •Current use of antipsychotics or untreated depression
- •Adherence to specialized diet regimens (food allergy, vegetarian, macrobiotic)
- •Binge eating disorder
- •Planning to movie to a location and no longer having access to rural clinic site
结局指标
主要结局
Mean Weight Change Over 6 Months
时间窗: Change in baseline to 6 months
Mean weight change (kg) of participants between the three study groups.
次要结局
- Change in BMI Across 6 Months(Change from baseline to 6 months)
- Change in Waist Circumference Across 6 Months(Change from baseline - 6 months)
- Triglycerides(Change from baseline to 6 months)
- Change in Systolic Blood Pressure Across 6 Months(Change from baseline to 6 months)
- HDL-cholesterol(Change from baseline to 6 months)
- Change in Fasting Glucose Across 6 Months(Change from baseline to 6 months)
- Cost Effectiveness at 6 Months(6 months)