Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Study Overview
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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.

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.

Official Title
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Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Lifestyle Counseling
* Behavioral: Educational Control Arm


Participation Criteria
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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 Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Educational control arm<br>Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers | Behavioral: Educational Control Arm<br>* 16 mailings of diabetes educational materials but no regular contact with community health workers<br>|
| Experimental: Lifestyle counseling<br>Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers. | Behavioral: Lifestyle Counseling<br>* Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin A1c | Glycosylated hemoglobin | 6 months | 
| Change in Hemoglobin A1c | Glycosylated hemoglobin | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Weight | Body weight | 6 Months | 
| Change in Weight | Body Weight | 12 Months |