Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Educational control arm

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

Group Type ACTIVE_COMPARATOR

Educational Control Arm

Intervention Type BEHAVIORAL

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

Lifestyle counseling

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

Group Type EXPERIMENTAL

Lifestyle Counseling

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyle Counseling

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

Intervention Type BEHAVIORAL

Educational Control Arm

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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