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
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Behavioral: Lifestyle Counseling
Behavioral: Educational Control Arm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Empowering Rural African American Women and Communities to Improve Diabetes Outcomes

Resource links provided by NLM:


Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Educational control arm
Control group receives 16 mailings of diabetes educational materials but no regular contact with community health workers
Behavioral: Educational Control Arm
16 mailings of diabetes educational materials but no regular contact with community health workers
Experimental: Lifestyle counseling
Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers.
Behavioral: Lifestyle Counseling
Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers

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.

  Eligibility

Ages Eligible for Study:   19 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806194

Locations
United States, North Carolina
East Carolina University
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Investigators
Principal Investigator: Doyle M. Cummings, Pharm.D. East Carolina University
Principal Investigator: Lesley Lutes, Ph.D. East Carolina University
  More Information

No publications provided

Responsible Party: Doyle M. Cummings, Professor of Family Medicine, East Carolina University
ClinicalTrials.gov Identifier: NCT01806194     History of Changes
Other Study ID Numbers: 212196
Study First Received: December 5, 2012
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014