Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Behavioral: Lifestyle Counseling; Behavioral: Educational Control Arm

• Registration Number: NCT01806194
• Lead Sponsor: East Carolina University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle counseling	Lifestyle Counseling	Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.
Educational control arm	Educational Control Arm	Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1c	12 Months	Glycosylated hemoglobin

Secondary Outcome Measures

Name	Time	Method
Change in Weight	12 Months	Body Weight

Trial Locations

Locations (1)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States