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Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01806194
Acronym
EMPOWER
Enrollment
200
Registered
2013-03-07
Start date
2012-01-31
Completion date
2014-07-31
Last updated
2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

BEHAVIORALLifestyle Counseling

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

BEHAVIORALEducational Control Arm

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

Sponsors

East Carolina University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in Hemoglobin A1c6 monthsGlycosylated hemoglobin

Secondary

MeasureTime frameDescription
Change in Weight6 MonthsBody weight

Other

MeasureTime frameDescription
Blood pressure6 monthsBlood pressure
Blood Pressure12 MonthsBlood pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026