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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Doyle M. Cummings, East Carolina University
ClinicalTrials.gov Identifier:
NCT01806194
First received: December 5, 2012
Last updated: March 5, 2013
Last verified: March 2013

December 5, 2012
March 5, 2013
January 2012
November 2013   (final data collection date for primary outcome measure)
  • Change in Hemoglobin A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin
  • Change in Hemoglobin A1c [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Glycosylated hemoglobin
Same as current
Complete list of historical versions of study NCT01806194 on ClinicalTrials.gov Archive Site
  • Change in Weight [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Body weight
  • Change in Weight [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Body Weight
Same as current
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood pressure
  • Blood Pressure [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Blood pressure
Same as current
 
Empowering Rural African American Women and Communities to Improve Diabetes Outcomes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Behavioral: Lifestyle Counseling
    Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers
  • Behavioral: Educational Control Arm
    16 mailings of diabetes educational materials but no regular contact with community health workers
  • Active Comparator: Educational control arm
    Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers
    Intervention: Behavioral: Educational Control Arm
  • Experimental: Lifestyle counseling
    Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.
    Intervention: Behavioral: Lifestyle Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
November 2013
November 2013   (final data collection date for primary outcome measure)

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:

-

Female
19 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01806194
212196
No
Doyle M. Cummings, East Carolina University
East Carolina University
Not Provided
Principal Investigator: Doyle M. Cummings, Pharm.D. East Carolina University
Principal Investigator: Lesley Lutes, Ph.D. East Carolina University
East Carolina University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP