A Patient-Centered Strategy for Improving Diabetes Prevention in Urban American Indians
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 4
- 主要终点
- Change From Baseline in Body Mass Index (BMI) Through Month 12
研究概览
简要总结
The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaska Native people within a primary care setting.
详细描述
The goal of the proposed research is to identify effective patient-centered strategies to prevent diabetes in high-risk populations in real world settings. The investigators will accomplish this by conducting a randomized controlled trial comparing an enhanced Diabetes Prevention Program addressing psychosocial stressors to a standard version in a high-risk population of urban American Indian and Alaska Native peoples within a primary care setting. Diabetes is disproportionately prevalent among low-socioeconomic status and racial/ethnic minority populations in the US. The high prevalence of psychosocial stressors such as depression, discrimination, and exposure to trauma among these populations contributes to the high prevalence of diabetes and interferes with successful completion of lifestyle interventions. The investigators hypothesize that a DPP that directly addresses these psychosocial stressors will be superior to the standard DPP in addressing this disparity in diabetes.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Urban of Indigenous Ancestry from the Americas (North, Central and South America)
- •Men and women
- •BMI Between 30-55
- •Not diagnosed with Type II Diabetes
- •At least one of the following criterion
- •Triglycerides: 150mg/dL or higher
- •Reduced HDL: <40mg/dL (men); <50mg/dL (women)
- •Blood pressure: >130/80 or current treatment with antihypertensives
- •Fasting glucose: >100mg/dL
排除标准
- •Significant medical comorbidities, including uncontrolled metabolic disorders (e.g., thyroid, diabetes, renal, liver), unstable heart disease, heart failure, and ongoing substance abuse;
- •On greater than 10 prescription medications.
- •Psychiatric disorders requiring atypical antipsychotics or multiple medications;
- •Inappropriate for moderate exercise according to the Revised Physical Activity Readiness Questionnaire;
- •Pregnant, planning to become pregnant, or lactating;
- •Family household member already enrolled in the study;
- •Already enrolled or planning to enroll in a clinical trial that would limit full participation in the study;
- •Resident of a long term care facility;
- •Lack of spoken English by patient or a household member > 18 y who can serve as interpreter;
- •Plans to move during the study period (9 months post-randomization);
- •Investigator discretion for clinical safety or adherence reasons (e.g., unstable housing, chronic pain).
结局指标
主要结局
Change From Baseline in Body Mass Index (BMI) Through Month 12
时间窗: Change through month 12, with assessments at baseline, 6 months, and 12 months
BMI is measured as weight in kg divided by the square of height in meters.
Change From Baseline in the Quality of Life Short Form Survey (SF-12)
时间窗: Change through month 12, with assessments at baseline, 6 months, and 12 months
SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey to evaluate overall health-related quality of life. Answers are combined, scored and weighted into mental and physical functioning component scales. The scores for each scale range from 0 to 100. A higher value indicates a better quality of life of the patient.
次要结局
- Change From Baseline in Empowerment(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in Food Frequency Questionnaire (FFQ) Score as a Measure of Healthy and Unhealthy Diet Choices(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in Physical Activity Measured in Metabolic Equivalents (MET) Per Week(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in the Center for Epidemiologic Studies - Depression Scale (CES-D) as a Measure of Mental Health Symptoms(Change through month 12, with assessments at baseline, 6 months, and 12 months)
- Change From Baseline in Empowerment(Change through month 12, with assessments at baseline, 6 months, and 12 months)
研究者
Randall Stafford
Professor of Medicine
Stanford University