A Church Based Intervention to Improve Diabetes Care

University of North Carolina (UNC)

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Behavioral: Special Intervention; Behavioral: Delayed Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00311324

99-0960

U48/CCU409660, 22PR-99 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Special Intervention

Experimental group

Description:

One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls.

Treatment:

Behavioral: Special Intervention

Delayed Intervention

Experimental group

Description:

Direct mailing of two American Dietary Association pamphlets ("Healthy Eating" and "Staying Alive") and three bimonthly newsletters providing general health information and study updates.

Treatment:

Behavioral: Delayed Intervention