Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
201 participants
INTERVENTIONAL
2001-02-28
2003-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Special Intervention
One individual counseling visit, twelve group sessions, three postcards, and twelve telephone calls.
Special Intervention
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.
Delayed Intervention
Interventions
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Special Intervention
Delayed Intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy/lactation
* inability to speak English
20 Years
99 Years
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Thomas C. Keyserling, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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Center for Health Promotion and Disease Prevention/UNC-Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Related Links
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Prev Chronic Disease \[serial online\] 2006 Jul \[date cited\].
Other Identifiers
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U48/CCU409660, 22PR-99
Identifier Type: OTHER
Identifier Source: secondary_id
99-0960
Identifier Type: -
Identifier Source: org_study_id
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