Empowering Rural African American Women and Communities to Improve Diabetes Outcomes (EMPOWER)

University of North Carolina System

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: Educational Control Arm; Behavioral: Lifestyle Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01806194

212196

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Educational control arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Educational Control Arm

Lifestyle counseling

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Counseling