A Church Based Intervention to Improve Diabetes Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Church Based Intervention to Improve Diabetes Care

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Special Intervention
* Behavioral: Delayed Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Special Intervention<br>One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls. | Behavioral: Special Intervention<br> <br> * Other names: Diabetes self care (behavior);|
| Experimental: Delayed Intervention<br>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<br> <br> * Other names: Diabetes self care (behavior);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Dietary recall saturated fat consumption |  |  | 
| Median number of minutes per day engaged in physical activity | Light, Moderate, and Vigorous metabolic equivalents (MET) |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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behavioral intervention