NCT01084928已完成不适用
A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- body weight
研究概览
简要总结
The South Asian Community, people with origins in India, Pakistan, Bangladesh, Maldives, Nepal, Sri Lanka, or Bhutan, are more likely to get diabetes, get diabetes at younger ages, and do worse health-wise once they have diabetes than the general population. This study will test the feasibility and community acceptability of a culturally appropriate lifestyle intervention for the prevention of diabetes in the South Asian community. The outcomes of this project could be used to plan larger interventions to prevent diabetes in South Asians, a rapidly growing segment of the US population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self-identified as being of South Asian origin
- •Live in or near Atlanta, Georgia
- •BMI greater than 22 kg/m2 calculated from standardized weight and height measurements (a BMI of greater than 22 kg/m2 is indicative of overweight in the South Asian population)
- •A confirmed age greater than or equal to 25 determined by checking a valid photo identification (driver's license, passport, etc.)
- •No prior diabetes diagnosis (physician diagnosis or on diabetes medication)
- •A high risk of developing diabetes (pre-diabetes) as defined by a casual capillary glucose greater than or equal to 120 (measured during screening)
- •Fasting glucose of 100-125 mg/dL (impaired fasting glucose tolerance) and/or 2-hour post-load glucose of 140-199 mg/dL (impaired glucose tolerance), measured at baseline visit
- •No history of heart disease, serious illness, or conditions that may impede or prohibit participation and are not currently pregnant
排除标准
- •Capillary glucose less than 120
- •Fasting glucose less than 100 mg/dL or greater than 125 mg/dL OR 2 hour post-load glucose less than 140 mg/dL or greater than 199 mg/dL
- •Age less than 25 years
- •BMI less than 22 kg/m2
- •Pregnancy
- •History of heart disease or diabetes (other than gestational diabetes)
- •Current functional difficulties
- •Severe lung disease or cancer
- •Failure to pass cardiovascular stress test
结局指标
主要结局
body weight
时间窗: 24 weeks (16 week intervention, 8 week maintenance)
次要结局
- percent body fat(24 weeks (16 week intervention, 8 week maintenance))
- body mass index(24 weeks (16 week intervention, 8 week maintenance))
- waist-to-hip ratio(24 weeks (16 week intervention, 8 week maintenance))
- fasting glucose(24 weeks (16 week intervention, 8 week maintenance))
- blood pressure(24 weeks (16 week intervention, 8 week maintenance))
- plasma lipids(24 weeks (16 week intervention, 8 week maintenance))
- self-reported physical activity(24 weeks (16 week intervention, 8 week maintenance))
- Percent of Total Calories from Fat(24 weeks (16 week intervention, 8 week maintenance))
研究者
Venkat Narayan
Hubert Professor of Global Health and Epidemiology
Emory University
研究点 (2)
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