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Completed

NCT Number: NCT01806194

Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

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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Key information

Age range

19 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University

Greenville, North Carolina, 27834, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Lifestyle Counseling

Behavioral

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

Educational Control Arm

Behavioral

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

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: 6 months

    Glycosylated hemoglobin

  2. Change in Hemoglobin A1c

    Time frame: 12 Months

    Glycosylated hemoglobin

Secondary outcomes

  1. Change in Weight

    Time frame: 6 Months

    Body weight

  2. Change in Weight

    Time frame: 12 Months

    Body Weight

Other outcomes

  1. Blood pressure

    Time frame: 6 months

    Blood pressure

  2. Blood Pressure

    Time frame: 12 Months

    Blood pressure

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Registry information

Acronym: EMPOWER

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2013
Registry last updated
Jan 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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