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临床试验/NCT03708380
NCT03708380终止不适用

Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own

研究概览

简要总结

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
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

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own

时间窗: Until the end of the two year study period

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.

Adherence to the intervention during the initial 60-day period when lunches are provided at no cost

时间窗: 60 days

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.

次要结局

  • First Point-of-care Hemoglobin A1c (HbA1c) test(Baseline)
  • Fourth Point-of-Care HbA1c Test(Post-Treatment (6 to 12 months after the intervention))
  • Photographic food and beverage diaries(Baseline)
  • Second Point-of-care HbA1C test(Baseline (3-6 months after first test))
  • Third Point-of-care HbA1C test(Post treatment (3 months after the intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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