A Church Based Intervention to Improve Diabetes Care
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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: diabetes self care (behavior) |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 280 |
| 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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 chuch 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| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00311324 History of Changes |
| Other Study ID Numbers: | Project 99-MED-412, U48/CCU409660 |
| Study First Received: | March 31, 2006 |
| Last Updated: | March 31, 2006 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of North Carolina, Chapel Hill:
|
behvioral intervention |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013