A Church Based Intervention to Improve Diabetes Care

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Special Intervention; Behavioral: Delayed Intervention

• Registration Number: NCT00311324
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

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.

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2006-03-31
• Study First Submitted QC: 2006-03-31
• Study First Posted: 2006-04-05
• Status Verified: 2015-12
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

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Exclusion Criteria

• diabetes secondary to another condition
• pregnancy/lactation
• inability to speak English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Special Intervention	Special Intervention	One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls.
Delayed Intervention	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.

Primary Outcome Measures

Name	Time	Method
Mean Hemoglobin A1c		5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.

Secondary Outcome Measures

Name	Time	Method
Mean Dietary recall saturated fat consumption
Median number of minutes per day engaged in physical activity		Light, Moderate, and Vigorous metabolic equivalents (MET)

Trial Locations

Locations (1)

Center for Health Promotion and Disease Prevention/UNC-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States