Community Translation of a Lifestyle Intervention to Improve Health in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 2
- 主要终点
- Percent Change in Body Weight
研究概览
简要总结
The purpose of this study is to compare ways of giving advice and providing support to improve diet and physical activity in adult primary care patients with elevated body mass index and dysglycemia.
详细描述
This is a randomized comparative effectiveness trial to evaluate the health and economic effects of a community-based intensive lifestyle intervention for adult primary care patients with elevated body mass index and dysglycemia (either type 2 diabetes or pre-diabetes). The study will use qualitative and quantitative methods to assess reach, effectiveness, costs, adoption, implementation, and maintenance of a clinical-community partnership to offer intensive lifestyle intervention resources to eligible adult primary care patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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, AND
- •Body-mass index of ≥ 24 kg/m2, AND
- •Documented Dysglycemia: Either by verification of laboratory test (Fasting Plasma Glucose 100-125 mg/dl OR 2-hour Post-challenge Plasma Glucose 140-199 mg/dl OR A1c 5.7%-10.9%) OR confirmation of Type 2 diabetes mellitus by self-report with verification
排除标准
- •(any of the following):
- •Diseases/Conditions that could limit lifespan and/or increase risk with a lifestyle intervention:
- •Significant cardiovascular disease:
- •Uncontrolled hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >105 mmHg
- •A1c > 10.9%
- •Heart attack, stroke, or transient ischemic attack (TIA) in the past 6 months
- •Chest pain, dizziness, or fainting with physical exertion
- •Lung disease:
- •Chronic obstructive airways disease or asthma requiring home oxygen
- •Any other known condition that could limit ability to become physically active or limit life span to <5 years
- •Exclusions related to metabolism:
- •Use of medications known to produce hyperglycemia
- •Known disease leading to abnormal glucose metabolism, other than diabetes mellitus, including Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
- •Exclusion for conditions or behaviors likely to affect the conduct of the study:
- •Unable or unwilling to provide informed consent
- •Unable to communicate with the pertinent research study staff
- •Unable to read written English or Spanish
研究组 & 干预措施
Standard Lifestyle Advice
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant).
干预措施: Standard Lifestyle Advice (Behavioral)
Advice Plus Lifestyle Intervention
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
干预措施: Advice Plus Lifestyle Intervention (Behavioral)
Advice Plus Lifestyle Intervention
Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting.
干预措施: Standard Lifestyle Advice (Behavioral)
结局指标
主要结局
Percent Change in Body Weight
时间窗: Baseline to 12 months
(Body weight at 12 months subtracted from baseline body weight) divided by baseline body weight. Negative numbers indicate a weight loss.
次要结局
- Incremental Costs(6, 12, and 24 months)
- Changes in Health State Utility(Baseline to 6,12, and 24 months)
- Percent Change in Body Weight(Baseline to 6 and 24 months)
- Percent Change in Blood Total Cholesterol(Baseline to 6, 12, and 24 months)
- Percent Change in A1c(Baseline to 6, 12, and 24 months)
- Percent Change in Blood Pressure(Baseline to 6, 12, and 24 months)
- Percent Change in Dietary Composition(Baseline to 6, 12, and 24 months)
- Percent Change in Physical Activity(Baseline to 6, 12, and 24 months)
研究者
Ronald Ackermann
Professor of Medicine
Northwestern University