A Church Based Intervention to Improve Diabetes Care
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|ClinicalTrials.gov Identifier: NCT00311324|
Recruitment Status : Completed
First Posted : April 5, 2006
Last Update Posted : December 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Behavioral: Special Intervention Behavioral: Delayed Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Church Based Intervention to Improve Diabetes Care|
|Study Start Date :||February 2001|
|Actual Primary Completion Date :||August 2003|
|Actual Study Completion Date :||August 2003|
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)
- Mean Hemoglobin A1c5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.
- Mean Dietary recall saturated fat consumption
- Median number of minutes per day engaged in physical activityLight, Moderate, and Vigorous metabolic equivalents (MET)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|