NCT01766271已完成不适用
GENErating Change, An Integrative Health Coaching and Genetic Risk Testing Pilot in Primary Care: A Multidisciplinary Approach to Personalized Medicine Targeting CHD Risk
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 主要终点
- Diet
研究概览
简要总结
The purpose of this 4 group (2x2) pilot randomized controlled trial is to test the feasibility and logistics of incorporating genetic risk information (9p21)into standard Coronary Heart Disease (CHD) risk counseling or health coaching intervention (or both) in primary care at 2 Duke Clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •presence of at least one of the following:
- •FPG > 100,
- •HbA1c > 5.7%,
- •diabetic,
- •LDL > 129,
- •triglycerides > 150,
- •total cholesterol > 200,
- •SBP > 130,
- •BMI > 25,
- •able to speak and understand English,
- •able and willing to give informed consent
排除标准
- •diagnosed CHD (MI or documented coronary artery disease),
- •inability to ambulate or participate in physical activity,
- •serious chronic disease related complications,
- •current participation in a risk communication study for chronic disease,
研究组 & 干预措施
SRA plus Health Coaching plus Genetic Testing
Experimental
干预措施: 9p21 (Genetic)
SRA plus Health Coaching plus Genetic Testing
Experimental
干预措施: Standard Risk Assessment (Other)
Standard Risk Assessment (SRA) Only
Experimental
干预措施: Standard Risk Assessment (Other)
SRA plus Genetic Testing
Experimental
干预措施: Standard Risk Assessment (Other)
SRA plus Health Coaching plus Genetic Testing
Experimental
干预措施: Health Coaching (Behavioral)
SRA plus Health Coaching
Experimental
干预措施: Health Coaching (Behavioral)
SRA plus Health Coaching
Experimental
干预措施: Standard Risk Assessment (Other)
SRA plus Genetic Testing
Experimental
干预措施: 9p21 (Genetic)
结局指标
主要结局
Diet
时间窗: 6 months
National Cancer Institute (NCI) Multifactor Screener
Physical Activity
时间窗: 6 months
Stanford Brief Activity Scale (SBAS)
次要结局
- Fasting blood glucose(6 months)
- Systolic blood pressure(6 months)
- Body mass index(6 months)
- Waist circumference(6 months)
- Low Density Cholesterol (LDL)(6 months)
- Triglyceride(6 months)
- Total cholesterol(6 months)
研究者
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