Diabetes Prevention for Black Men
2021年6月10日 更新者：NYU Langone Health
Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.
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
-
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New York
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New York、New York、美国、10016
- New York University School of Medicine
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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
18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:
- Black or African American men who work as barbers at Black-owned barbershops
- Barbershop clients.
- Workplace in neighborhood geographically identified as having higher diabetes burden
- No prior history of clinical diagnosis of diabetes
- Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater
Exclusion Criteria:
- Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
- Individuals with a history of food allergies that requires specific dietary restrictions
- Individuals who are not English speaking
- Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
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：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：Dietary intervention
Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes
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Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.
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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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Adherence to the intervention during the initial 60-day period when lunches are provided at no cost
大体时间：60 days
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Adherence will be calculated as the proportion of participants continuing to consume at least 80% of the lunch meals at the end of the initial intervention period when lunches will be provided at no cost.
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60 days
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Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
大体时间：Until the end of the two year study period
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proportion of participants continue to purchase meals after the initial intervention period when individuals will be given the option to continue the intervention but paying for the lunch meals themselves.
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Until the end of the two year study period
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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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Photographic food and beverage diaries
大体时间：Baseline
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Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns
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Baseline
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First Point-of-care Hemoglobin A1c (HbA1c) test
大体时间：Baseline
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This first baseline point-of-care HbA1c test will be used as a reference.
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Baseline
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Second Point-of-care HbA1C test
大体时间：Baseline (3-6 months after first test)
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This second baseline point-of-care HbA1c test will be used to identify any changes in glycemic control that developed after initial diagnosis of diabetes or prediabetes by the first point-of-care test.
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Baseline (3-6 months after first test)
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Third Point-of-care HbA1C test
大体时间：Post treatment (3 months after the intervention)
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This post-treatment HbA1c test will be used to identify whether there was any short-term change in glycemic control after the dietary intervention
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Post treatment (3 months after the intervention)
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Fourth Point-of-Care HbA1c Test
大体时间：Post-Treatment (6 to 12 months after the intervention)
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This post-treatment HbA1c test will be used to identify whether there was any longer-term change in glycemic control after the dietary intervention
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Post-Treatment (6 to 12 months after the intervention)
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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：David Lee, MD、NYU Langone Health
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)
2019年3月25日
初级完成 (实际的)
2020年6月23日
研究完成 (实际的)
2020年6月23日
研究注册日期
首次提交
2018年9月14日
首先提交符合 QC 标准的
2018年10月12日
首次发布 (实际的)
2018年10月17日
研究记录更新
最后更新发布 (实际的)
2021年6月11日
上次提交的符合 QC 标准的更新
2021年6月10日
最后验证
2021年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
IPD 共享时间框架
Beginning 3 months and ending 5 years following article publication.
IPD 共享访问标准
Researchers who provide a methodologically sound proposal will have access to the data.
Requests should be directed to david.lee@nyumc.org.
To gain access, data requestors will need to sign a data access agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Dietary intervention的临床试验
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人