A Church Based Intervention to Improve Diabetes Care

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00311324
First received: March 31, 2006
Last updated: December 3, 2015
Last verified: December 2015
  Purpose
The purpose of this study it to determine if a culturally appropriate, church based intervention for African Americans with type 2 diabetes, will lead to improved glycemic (blood sugar) control.

Condition Intervention
Type 2 Diabetes
Behavioral: Special Intervention
Behavioral: Delayed Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Church Based Intervention to Improve Diabetes Care

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Mean Hemoglobin A1c [ Designated as safety issue: No ]
    5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.


Secondary Outcome Measures:
  • Mean Dietary recall saturated fat consumption [ Designated as safety issue: No ]
  • Median number of minutes per day engaged in physical activity [ Designated as safety issue: No ]
    Light, Moderate, and Vigorous metabolic equivalents (MET)


Enrollment: 201
Study Start Date: February 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Special Intervention
One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls.
Behavioral: Special Intervention
Other Name: Diabetes self care (behavior)
Experimental: Delayed Intervention
Direct mailing of two American Dietary Association pamphlets ("Healthy Eating" and "Staying Alive") and three bimonthly newsletters providing general health information and study updates.
Behavioral: Delayed Intervention
Other Name: Diabetes self care (behavior)

Detailed Description:

African Americans suffer disproportionately from diabetes and its complications. To reduce this burden of suffering, innovative interventions are needed to improve self-care behaviors including: dietary intake, physical activity (PA), self-monitoring, and medication adherence. The goal of this study (A New DAWN) was to develop and test a culturally appropriate, church-based intervention to improve diabetes self-management and glycemic control.

Twenty-four African American churches in central NC were recruited and randomized to receive the special intervention (SI-13 churches, 117 participants) or the delayed intervention (DI-11 churches, 84 participants). The SI included an 8-month intensive phase consisting of: 1 individual dietary assessment and counseling visit; 12 group sessions; monthly phone contact with a peer counselor (church diabetes advisor (CDA)); and 3 printed encouragement messages from the primary care clinician. This was followed by a 4-month reinforcement phase including monthly phone contacts from the CDA. At 8- and 12-month follow-up, HbA1c was assessed by high-performance liquid chromatography.

At baseline, 64% of participants were female and means were: age 59, years with diabetes 9, HbA1c 7.8%, Systolic Blood Pressure 139, Diastolic Blood Pressure 76, and BMI 35.0. A total of 174 (87%) participants returned for 8-month measures. Adjusting for baseline values and randomization by church, the mean HbA1c level was 7.4% for the SI and 7.8% for the DI (difference 0.4%, 95% Confidence Interval (CI) 0.1-0.6, p = 0.009). There were no statistically significant differences between groups for BP or BMI. Of 82 (70%) SI participants completing an 8-month follow-up questionnaire, 65 (79%) were very satisfied with the nutritional component, 63 (77%) were very satisfied with the PA component, and 72 (88%) considered the program to be very helpful overall.

In A New DAWN, the SI was acceptable and produced a modest, but clinically significant, reduction in HbA1c. These findings support the acceptability and effectiveness of self-management interventions given in a church setting for African Americans with type 2 diabetes.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 20 or older
  • diagnosis of type 2 diabetes (diagnosis at age 20 or greater and no history of ketoacidosis)
  • clinical care provided by primary care clinician
  • plans to reside within 50 miles of church for 1 year
  • has home phone or easy access to one

Exclusion Criteria:

  • diabetes secondary to another condition
  • pregnancy/lactation
  • inability to speak English
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311324

Locations
United States, North Carolina
Center for Health Promotion and Disease Prevention/UNC-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Thomas C. Keyserling, MD, MPH University of North Carolina, Chapel Hill
  More Information

Additional Information:
No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00311324     History of Changes
Other Study ID Numbers: 99-0960  U48/CCU409660, 22PR-99 
Study First Received: March 31, 2006
Last Updated: December 3, 2015
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
behavioral intervention

ClinicalTrials.gov processed this record on February 11, 2016