A Culturally Tailored Lifestyle Intervention to Prevent Diabetes in South Asians (SHAPE)
2013年9月24日 更新者:Venkat Narayan、Emory University
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.
研究概览
研究类型
介入性
注册 (实际的)
16
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intervention Arm (Diet and Exercise)
The lifestyle intervention will include a 16-week intervention period, followed by an 8 week, less intensive maintenance period.
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The intervention will be based on the Diabetes Prevention Program but tailored to the needs of the community based on feedback gathered in focus groups.
Classes will be group-based and will use a variety of teaching techniques and group-based work to teach participants about behavior change, diet, and physical activity.
Participant will be required to attend one group exercise class per week based on traditional Indian dances and other culturally appropriate activities.
In order to reach their weekly exercise goal of 150 minutes or more per week, participants will also be able to attend an additional group exercise class, an organized group walk, do a culturally-tailored work out video created by the study staff, and/or exercise on their own.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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body weight
大体时间:24 weeks (16 week intervention, 8 week maintenance)
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24 weeks (16 week intervention, 8 week maintenance)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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percent body fat
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
|
body mass index
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
|
waist-to-hip ratio
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
|
fasting glucose
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
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blood pressure
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
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plasma lipids
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
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self-reported physical activity
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
|
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Percent of Total Calories from Fat
大体时间:24 weeks (16 week intervention, 8 week maintenance)
|
24 weeks (16 week intervention, 8 week maintenance)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员:Venkat Narayan, MD, PhD、Emory University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年4月1日
初级完成 (实际的)
2012年7月1日
研究完成 (实际的)
2012年7月1日
研究注册日期
首次提交
2010年3月1日
首先提交符合 QC 标准的
2010年3月9日
首次发布 (估计)
2010年3月11日
研究记录更新
最后更新发布 (估计)
2013年9月25日
上次提交的符合 QC 标准的更新
2013年9月24日
最后验证
2013年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.