A Church Based Intervention to Improve Diabetes Care

Type 2 Diabetes Clinical Trial

Official title:

A Church Based Intervention to Improve Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311324
• Other study ID #: 99-0960
• Secondary ID: U48/CCU409660, 2
• Status: Completed
• Phase: N/A
• Start date: February 2001
• Est. completion date: August 2003

Study information

• Verified date: December 2015
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

Behavioral:
• Special Intervention

• Delayed Intervention

Locations

Country	Name	City	State
United States	Center for Health Promotion and Disease Prevention/UNC-Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Hemoglobin A1c	5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.
Secondary	Mean Dietary recall saturated fat consumption
Secondary	Median number of minutes per day engaged in physical activity	Light, Moderate, and Vigorous metabolic equivalents (MET)

External Links

•   Prev Chronic Disease [serial online] 2006 Jul [date cited].