Community-based Adolescent Diabetes Prevention Program
2019年11月20日 更新者：Icahn School of Medicine at Mount Sinai
TEEN HEED: An Adolescent Peer Led Diabetes Prevention Intervention
The number of youth with type 2 diabetes is predicted to quadruple by 2050, with a disproportionate increase among minority youth.
The research proposed in this Career Development Award will use community-based participatory research methodology as well as novel strategies (peer education and mobile health technologies) to design, implement and evaluate a diabetes prevention intervention for at-risk ethnic minority youth in an urban community with high disease burden.
研究概览
详细说明
Approach: The proposed research addresses diabetes risk and prevention among racial/ethnic minority adolescents in East Harlem (EH), NY.
Aim 1 will use qualitative methods to explore the best strategies for using peer education for diabetes risk reduction in youth and the potential role of mobile health technologies in improving adherence to behavioral modification plans.
Aim 2 will utilize findings from preliminary studies and Aim 1 to design and evaluate a pilot community-based intervention to 1) maintain/reduce BMI (primary outcome), 2) improve adolescent dietary, physical activity and weight control behaviors, and 3) improve other measures of diabetes risk.
Data will be collected at baseline, immediately after the intervention (3 months) and at one year in the intervention and wait list control groups.
Aim 3 involves refining the pilot intervention based on an examination of intervention feasibility, acceptability, and sustainability and planning for a future R01.
研究类型
介入性
注册 (实际的)
90
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
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New York
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New York、New York、美国、10029
- Icahn School Of Medicine At Mount Sinai
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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
13年 至 19年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria for pre-diabetes screening:
- Adolescents ages 13-19 years of age
- English speaking
Residents of East Harlem or members of an East Harlem Institution. Membership in an East Harlem institution includes the following:
- attending a school in East Harlem
- attending an after school or recreational activity in East Harlem
- receiving health care in East Harlem Proof of address or membership in an East Harlem institution will not be asked.
- At risk for diabetes (overweight/obese based on measured BMI percentile and with either a parent or grandparent with type 2 diabetes)
- No plans to relocate from New York City in the next year
Note: additional inclusion criteria for participation in workshops include diagnosis of pre-diabetes based on oral glucose tolerance test
Exclusion Criteria for pre-diabetes screening:
- <13 or >19 years of age
- Previous diagnosis of diabetes
- BMI percentile <85th percentile for age and gender based on Centers for Disease Control and Prevention definition
- Currently pregnant
- Speaking a language other than English
- On medications that may raise or lower blood sugar
- Plans to relocate from New York City within one year of enrollment-
Note: additional exclusion criteria for participation in workshops include fingerstick glucoses outside the pre-diabetes range during oral glucose tolerance testing and any cognitive or physical impairment that would preclude comprehension of the group educational program
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：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：TEEN HEED
Adolescent pre-diabetics will receive 8-12 weekly peer-led diabetes prevention educational workshops in community sites.
The in-person group workshops will be supplemented by support through mobile health technologies such as text messaging and social media.
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Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
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无干预：Wait List Control
Adolescent pre-diabetics in this group will not receive any intervention until collection of all follow up data and will then be offered the same intervention as the participants in the experimental arm.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in body mass index (BMI)
大体时间：Baseline and 3 months
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Change in BMI at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in BMI
大体时间：Baseline and 1 year
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Change in BMI at 1 year as compared to baseline
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Baseline and 1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in fasting blood glucose levels
大体时间：Baseline and 3 months
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Change in fasting blood glucose levels at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in fasting blood glucose levels
大体时间：Baseline and 1 year
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Change in fasting blood glucose levels at 1 year as compared to baseline
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Baseline and 1 year
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Change in post prandial blood glucose level
大体时间：Baseline and 3 months
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Change in post prandial blood glucose level at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in post prandial blood glucose level
大体时间：Baseline and 1 year
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Change in post prandial blood glucose level at 1 year as compared to baseline
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Baseline and 1 year
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Change in blood pressure
大体时间：Baseline and 3 months
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Change in blood pressure at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in blood pressure
大体时间：Baseline and 1 year
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Change in blood pressure at 1 year as compared to baseline
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Baseline and 1 year
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Change in percent body fat
大体时间：Baseline and 3 months
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Change in percent body fat at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in percent body fat
大体时间：Baseline and 1 year
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Change in percent body fat at 1 year as compared to baseline
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Baseline and 1 year
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Change in waist circumference
大体时间：Baseline and 3 months
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Change in waist circumference at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in waist circumference
大体时间：Baseline and 1 year
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Change in waist circumference at 1 year as compared to baseline
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Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
大体时间：Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at post-intervention (approximately 3 months) as compared to baseline
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Baseline and 3 months
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Change in knowledge, attitudes, beliefs and behaviors related to diabetes and weight loss
大体时间：Baseline and 1 year
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Change in knowledge, attitudes, beliefs and behaviors (from the TEEN HEED survey) at 1 year as compared to baseline
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Baseline and 1 year
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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。
调查人员
- 首席研究员：Nita Vangeepuram, MD, MPH、Icahn School Of Medicine At Mount Sinai
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 (实际的)
2016年11月11日
初级完成 (实际的)
2019年8月24日
研究完成 (实际的)
2019年8月24日
研究注册日期
首次提交
2015年5月22日
首先提交符合 QC 标准的
2015年5月27日
首次发布 (估计)
2015年5月29日
研究记录更新
最后更新发布 (实际的)
2019年11月21日
上次提交的符合 QC 标准的更新
2019年11月20日
最后验证
2019年11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.