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临床试验/NCT03208686
NCT03208686已完成不适用

Self-Management of Diabetes in Black Men

Michigan State University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2019年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Blood glucose levels

研究概览

简要总结

The purpose of this application is to create and implement a targeted, culturally grounded, diabetes self-management intervention for Black men that uses social support, mobile health, and remote sensing technology to improve diabetes-related outcomes.

详细描述

The investigators propose a single-subject, repeated measures intervention where each participant will serve their own control. Participants will serve as their own controls for a period of three months prior to the start of the four-month intervention. The study will conclude with an assessment 7-months from baseline. Single-subject designs are most often used in applied research. The design allows the participant to serve as the control, rather than using another individual/group. The design is sensitive to individual differences whereas group designs are sensitive to averages of groups. Year 1 is dedicated to the development of the text messages and the content for the 10 group meeting sessions. Year 2 focuses on the Time-1 control period assessment (pre-baseline at 3 months before the intervention), the Time-2 assessment (baseline), implementation of the 10-week intervention, a post-intervention assessment (Time-3), and 3-month follow up at Time-4, and analysis. Specifically, in Year 2, the primary outcome of A1c will be assessed at Time-1, 3 months later at the start of the intervention, at the end of the intervention, and at 7-months. The investigators will also include secondary assessments of glucose readings, waist circumference, and blood pressure.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Black/African American
  • Tyep 2 Diabetes
  • 21 years old or older
  • Owns cell or smart (mobile) phone or willing to use one if provided

排除标准

  • Non-ambulatory
  • Serious physical illness
  • Psychiatric diagnosis of serious mental illness
  • Serious diabetes complications impeding meaningful participation

研究组 & 干预措施

Intervention Group

Other

A single-arm intervention comprised of discussion groups, text messages, and a cloud-based cellular glucometer.

干预措施: Intervention Group (Behavioral)

结局指标

主要结局

Blood glucose levels

时间窗: 4 Months

A1c

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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