Viewing Study NCT00004983



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Study NCT ID: NCT00004983
Status: COMPLETED
Last Update Posted: 2010-02-15
First Post: 2000-03-13

Brief Title: Education and Group Support for Diabetic Hispanics
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2010-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
R01DK048160 NIH None httpsreporternihgovquickSearchR01DK048160