A Church Based Intervention to Improve Diabetes Care
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Church Based Intervention to Improve Diabetes Care|
- Hemoglobin A1c
- Diet (change in saturated fat)
- Physical Activity
|Study Start Date:||February 2001|
|Estimated Study Completion Date:||August 2003|
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%, SBP 139, DBP 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% 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311324
|United States, North Carolina|
|Center for Health Promotion and Disease Prevention/UNC-Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Thomas C. Keyserling, MD, MPH||University of North Carolina, Chapel Hill|