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Completed

NCT Number: NCT00311324

A Church Based Intervention to Improve Diabetes Care

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.

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Key information

Age range

20 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Promotion and Disease Prevention/UNC-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Special Intervention

Behavioral

Other names: Diabetes self care (behavior)

Delayed Intervention

Behavioral

Other names: Diabetes self care (behavior)

Primary outcomes

  1. Mean Hemoglobin A1c

    5 µL capillary blood collected using standard finger-stick technique and assessed by automated affinity high-performance liquid chromatography.

Secondary outcomes

  1. Mean Dietary recall saturated fat consumption

  2. Median number of minutes per day engaged in physical activity

    Light, Moderate, and Vigorous metabolic equivalents (MET)

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Apr 5, 2006
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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