Translating Research Into the Prevention of Diabetes Mellitus (TRIP DM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 2
- 主要终点
- Fasting Glucose
研究概览
简要总结
The Healthy Living Partnership to Prevent Diabetes (HELP PD) is a 300-participant randomized trial designed to test the effectiveness of a lay-health counselor led community-based diabetes prevention program in reducing blood glucose in people at risk for developing diabetes mellitus.
详细描述
Social forces have promoted adverse behavioral patterns with respect to physical activity and nutrition resulting in the current epidemics of obesity, the metabolic syndrome and type 2 diabetes mellitus (DM). Results from clinical trials such as the Diabetes Prevention Program (DPP) have demonstrated a significant potential for prevention of type 2 DM through lifestyle interventions to promote physical activity, a healthy eating pattern and weight loss. Yet these approaches are not being applied in practice. In fact, whether these approaches can be successfully implemented in the community is an unanswered question. The Healthy Living Partnership to Prevent Diabetes (HELP PD) was designed to address this knowledge gap in a community setting. It incorporates key translations of prior research to enhance logistical and fiscal feasibility and long term dissemination, including the use of a group-based, rather than an individual-based, intensive lifestyle behavioral intervention employing professionals and community health workers (CHWs), and delivery of the intervention in the community setting via expansion of an existing Diabetes Education Program (DEP). The trial has been continued for an additional 5 years, and the primary goal of the continuation is to test the long-term glucose lowering effects of the HELP PD intervention by randomizing the lifestyle group to continued group maintenance or a self-directed maintenance condition and to follow the UC group for additional comparison purposes. Demonstrating the longer term effectiveness of HELP PD will represent a key step in establishing the value of this approach to translation of DM prevention into the community. This crucial evidence will be used to support reimbursement policy for DM prevention, dissemination of the HELP PD CHW approach and generalization to other behaviorally influenced chronic diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials
- •BMI greater than or equal to 25 kg/m2 but less than 40 kg/m2
- •Fasting blood glucose 95-125 mg/dl (inclusive)
- •Willingness to Accept Randomization
排除标准
- •Currently involved in a supervised program for weight loss
- •Clinical history of DM, or newly diagnosed DM at screening
- •Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure
- •Uncontrolled high blood pressure: BP > 160/100
- •Pregnancy, breast feeding, or planning pregnancy within 2 years
- •Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer
- •Chronic use of medicine known to significantly affect glucose metabolism, e.g., corticosteroids
- •Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP PD, major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), and participation in another research study that would interfere with HELP PD
结局指标
主要结局
Fasting Glucose
时间窗: Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization
Change in fasting glucose will be analyzed independently at 12 months (incorporating baseline and 6 month data) and will be used to report the average effect of the intervention during the first year. The analysis at 24 months (incorporating data from baseline, 18 and 24 months) will evaluate the long-term effects of the intervention by examining the average intervention effect during the second year of the intervention period.
次要结局
- Weight Loss(Change from Baseline at 6, 12, 18, 24, 36, 42, 48, 54, 60, 66, 72 and 78 months from randomization)
- Waist Circumference(Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization)
- Dietary Intake(Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization)
- Physical Activity(Change from Baseline at 6, 12, 24, 36, 48, 60, and 72 months from randomization)