Primary Care Community Partnerships to Prevent Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 509
- 试验地点
- 2
- 主要终点
- % Change in Body Weight
研究概览
简要总结
The purpose of this study is to determine if providing free-of-charge access to a group-based lifestyle intervention delivered in partnership with the community is cost-effective for the prevention of type 2 diabetes.
详细描述
Randomized controlled trials have shown that modest lifestyle changes can prevent or delay the onset of diabetes in adults with pre-diabetes. Unfortunately, despite the increasing prevalence of pre-diabetes and diabetes in all facets of the population, intervention programs needed to achieve these goals are costly and remain unavailable in most clinical settings. Over the past 3 years, we have demonstrated the feasibility of training community instructors to deliver a group-based adaptation of the Diabetes Prevention Program (DPP) lifestyle intervention. In this pilot research, this new delivery model achieves a level of weight reduction that was associated with diabetes prevention and improved cardiometabolic risk factor control in the DPP. This new, large-scale randomized effectiveness trial is designed to evaluate the costs and effectiveness of a partnered approach to identify adults with pre-diabetes in primary care settings, deliver brief advice for diabetes prevention, and provide access to a group-based adaptation of the DPP lifestyle intervention offered by the community. This study will compare costs and outcomes to a standard care, brief clinical counseling approach delivered by Registered Dietitians.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Body-mass index of 24 kg/m2 or greater
- •Fasting Blood Glucose 100 - 125 mg/dl, OR 2-hour Post-challenge Capillary Glucose 140 - 199 mg/dl
排除标准
- •Cancer requiring treatment in the past 5 years
- •Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- •Heart attack, stroke, or transient ischemic attack in the past 6 months,
- •Chronic obstructive airways disease or asthma requiring home oxygen
- •Other chronic disease or condition, such as advanced arthritis, that could limit ability to become physically active or limit life span to <5 years
- •Pregnancy
- •Existing diagnosis of diabetes mellitus
- •Fasting capillary blood glucose > 125 mg/dl
- •2-hour post-challenge capillary blood glucose > 199 mg/dl
- •History of anti-diabetic medication use (oral agents or insulin) except during gestational diabetes
- •Self-report of a medication known to lead to hyperglycemia (oral steroids, antipsychotics, anti-epileptics)
- •Self-report of disease associated with disordered glucose metabolism: Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
研究组 & 干预措施
Dietitian Counseling Alone
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian. Registered Dietitian Counseling Alone
干预措施: Dietitian Counseling Alone (Behavioral)
Dietitian Plus Community Group Lifestyle
Primary care-based identification of pre-diabetes with brief counseling by a dedicated registered dietitian, PLUS free-of-charge access to a group-based diabetes prevention lifestyle intervention offered by the community. Dietitian Counseling Plus Community Group Lifestyle Intervention.
干预措施: Dietitian Plus Community Group Lifestyle (Behavioral)
结局指标
主要结局
% Change in Body Weight
时间窗: 12 months
(weight in kg at 12 months - weight in kg at baseline) / (weight in kg at baseline)
次要结局
- Changes in Physical Activity(12 months)
- % Change in Blood Pressures(12 months)
- Changes in Dietary Composition(12 months)
- Incremental Health State Utility(12 months)
- % Change in Blood Total Cholesterol(12 months)
- % Change in glycosylated hemoglobin(12 months)
- Incremental Costs(12 months)
- % Change in Body Weight(24 months)
研究者
Ronald Ackermann
Senior Associate Dean for Public Health Director, Institute for Public Health and Medicine, Professor of Medicine
Northwestern University