Clinical trial NCT00004983: Education and Group Support for Diabetic Hispanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: diabetes mellitus, type 2
diabetes self-management education
diabetes self-care
blood glucose self-monitoring
health education
patient education
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2000-03-14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Sharon A. Brown
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown SA, Hanis CL. A community-based, culturally sensitive education and group-support intervention for Mexican Americans with NIDDM: a pilot study of efficacy. Diabetes Educ. 1995 May-Jun;21(3):203-10. doi: 10.1177/014572179502100307.
citation: Brown SA. Meta-analysis of diabetes patient education research: variations in intervention effects across studies. Res Nurs Health. 1992 Dec;15(6):409-19. doi: 10.1002/nur.4770150603.
citation: Brown SA, Hanis CL. Culturally competent diabetes education for Mexican Americans: the Starr County Study. Diabetes Educ. 1999 Mar-Apr;25(2):226-36. doi: 10.1177/014572179902500208.
citation: Brown SA, Upchurch SL, Garcia AA, Barton SA, Hanis CL. Symptom-related self-care of Mexican Americans with type 2 diabetes: preliminary findings of the Starr County Diabetes Education Study. Diabetes Educ. 1998 May-Jun;24(3):331-9. doi: 10.1177/014572179802400308.