Self-Management of Diabetes in Black Men
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
- 否
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
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
