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临床试验/NCT05038176
NCT05038176已完成不适用

Improving the Diabetic Health of Black Men (MANUP-NC): MANUP-NC Feasibility Trial

North Carolina Central University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月12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
50
试验地点
2
主要终点
A1c

研究概览

简要总结

Many Black Americans continue to be suffer from diabetes especially Black men. Although previous diabetes efforts have reduced overall disease burden, they have failed to eliminate racial and geographic disparities. The story of John Henry, the "steel-drivin' man" represents strength and self-determination among Black Men. But often these traits lead men to "manup" about their health and prevents them from taking care of their diabetes. This study examines how we can assist Black men in improving their diabetes. Based on the traits of John Henry, we will conduct a culturally-tailored study to 1) determine if our education program including coping strategies and motivation text messages lowers A1c; and, 2) how program operates in a rural setting while learning how we can best improve it for a larger study. We hope to have the information to conduct a larger study with Black men in rural areas to improve their diabetes outcomes.

详细描述

As the United States' 7th leading cause of death, improving diabetic outcomes is a public health priority. Black American men disproportionately suffer from diabetes more than White counterparts. John Henryism endorses traditional masculine norms for Black Men, such as self-determination and strength, as assets. However, these norms can also act as barriers to diabetes self-management as they restrict access to support from family and friends at a time when it is most needed.

The purpose of this application is to pilot a targeted, culturally-tailored, diabetes self-management intervention for 50 rural Black men to improve diabetes-related outcomes. Aim 1: Implement a 6-month diabetes self-management intervention, grounded in John Henryism, with two arms consisting of the active intervention group and a delayed intervention group to test the intervention's effect on the primary outcome of A1c change. Aim 2: Determine the feasibility of conducting a 6-month culturally-tailored diabetes self-management intervention for Black men in a rural NC community.

The intervention includes a 10-week education program focusing on self-management, social support and coping strategies; and, daily motivational text messages. Aim 1 analysis includes repeated measures t-test (or the non-parametric equivalent Wilcoxon Matched Pairs test) to compare the mean scores of the both groups pre and post intervention. Aim 2 analysis focuses on key parameters required for conducting a future trial. This innovative study leverages the self-reliance and active coping mechanisms of John Henryism by fostering self-determination to properly self-manage diabetes while providing stress management and coping skills to buffer John Henryism's adverse effects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
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

  • reside in Halifax, County or Alamance County NC; 2) age 21 or older; (3) English language proficient; 4) able to walk unaided; 4) self-reported type 2 diabetes diagnosis.

排除标准

  • Exclusion criteria includes being non-ambulatory or having a diagnosis that would preclude them from participating in an exercise program.

研究组 & 干预措施

Active intervention group (AI)

Experimental

The active intervention group (AI) receiving the active treatment (MANUP intervention) which include diabetes education, diabetes support with a focus on coping techniques (based on John Henryism concepts), physical activity engagement and motivational text messages.

干预措施: MANUP (Behavioral)

Delayed intervention group (DI)

Active Comparator

DI participants will only receive motivational text-messages. They will then "flip" and receive full intervention after the AI group has completed the program.

干预措施: MANUP (Behavioral)

结局指标

主要结局

A1c

时间窗: 6 months

Hemoglobin A1c (determine diabetes status over previous 2 months)

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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