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临床试验/NCT01806194
NCT01806194已完成不适用

Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

East Carolina University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年1月最近更新:
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
200
试验地点
2
主要终点
Change in Hemoglobin A1c

研究概览

简要总结

The EMPOWER diabetes program is a year-long, community-based program designed to enhance diabetes management in rural African American women with uncontrolled diabetes. The treatment is delivered by community peers and follows a relative Small Changes approach.

详细描述

East Carolina University, along with established community partners, is implementing a community-based and culturally-tailored intervention to reduce diabetes disparities in 200 rural African American women with uncontrolled diabetes using our unique behaviorally-centered small changes approach to diabetes self-management, delivered by community health workers. The focus is on moderation and patient-selected small changes in eating, activity, and care management that decrease feelings of deprivation and failure and increase feelings of confidence and success. The intervention is specifically tailored to overcome psychosocial and environmental barriers to behavioral change through a strong focus on emotional, cultural, and social factors related to eating, activity, and medications. Objectives for the proposed project are to: 1) implement and evaluate the effectiveness of this tailored small changes intervention; 2) examine the impact of this approach on psychological mediators of behavioral choices in diabetes; 3) implement and evaluate public policy and built environment advocacy strategies; and 4) build, sustain, and disseminate a business-sustainable care model. The study will be a randomized prospective trial comparing the small changes intervention, delivered in 16 sessions by community health workers, to a control group receiving 16 mailings of diabetes educational materials. We hypothesize that there will be a greater improvement in behavioral choices and glycemic control in the intervention group compared to the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • African American female,
  • age 19 - 75yr.,
  • with Type 2 diabetes mellitus and
  • living in or near Bertie, Edgecombe, and Pitt counties in eastern NC

排除标准

  • 未提供

研究组 & 干预措施

Educational control arm

Active Comparator

Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers

干预措施: Educational Control Arm (Behavioral)

Lifestyle counseling

Experimental

Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.

干预措施: Lifestyle Counseling (Behavioral)

结局指标

主要结局

Change in Hemoglobin A1c

时间窗: 12 Months

Glycosylated hemoglobin

次要结局

  • Change in Weight(12 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doyle M. Cummings

Professor of Family Medicine

East Carolina University

研究点 (2)

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