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Education and Group Support for Diabetic Hispanics

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00004983
First received: March 13, 2000
Last updated: February 12, 2010
Last verified: February 2010

March 13, 2000
February 12, 2010
September 1999
November 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004983 on ClinicalTrials.gov Archive Site
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Education and Group Support for Diabetic Hispanics
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The purpose of this ongoing work in Starr County, located on the Texas-Mexico border, is to conduct clinical studies to determine the effectiveness of diabetes self-management programs designed specifically for Mexican Americans. The programs meet national standards for diabetes self-management education. They are provided in community settings with the primary purpose of improving the health of Mexican Americans with diabetes and their family members, who either have diabetes or are at risk for developing diabetes.

The diabetes self-management programs are provided in Spanish and are directed by bilingual Hispanic clinical nurse specialists, dietitians, and community health workers. Key elements of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise, and other diabetes self-management topics, as well as group support to promote behavioral changes.

In the original study (1994-1998), 256 Mexican American adults diagnosed with type 2 diabetes and 256 family members or other support persons were enrolled. For one year, the people with diabetes, along with their family members, attended small group sessions held in churches, community health clinics, adult day care centers, and schools. Information on the effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter.

Findings of the original study suggested that the program had a positive impact on diabetes metabolic control. Levels of diabetes knowledge and rates of glucose self-monitoring and attendance suggested that a shorter program - one that incorporated critical elements of the previous successful strategy - might result in similar improvements. Thus, the goal of the new study, funded in June 1999, was to shorten the original program and to compare it to the previous successful program in terms of short- and long-term health outcomes.

To identify key components of the previous program, we are exploring differences between subjects who successfully integrated self-care components of the program and who experienced significant improvements in metabolic control and those who were not as successful. The program is being revised and shortened, based on this information. Beginning in April 2000, we will start recruiting participants for the clinical trial of the revised program.

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Interventional
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Allocation: Non-Randomized
Primary Purpose: Prevention
Diabetes Mellitus, Non-Insulin-Dependent
Behavioral: diabetes self-management education
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with type 2 diabetes ([a] two verifiable FBS test results of 140 mg/dl or above or [b] taking or have taken insulin or hypoglycemic agents for at least one year in the past)
  • Willing to participate
  • A family member, preferably a spouse or first-degree relative, who agrees to participate

Exclusion Criteria:

  • Migrant farm workers (not available for the year-long program)
  • Pregnant
  • Medical conditions for which changes in diet and exercise levels would be contraindicated
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004983
BROWNS (completed), R01DK48160
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Sharon A. Brown The University of Texas at Austin
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP