NCT00004983

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1999

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2000

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

7.2 years

First QC Date

March 13, 2000

Last Update Submit

February 12, 2010

Conditions

Keywords

diabetes mellitus, type 2diabetes self-management educationdiabetes self-careblood glucose self-monitoringhealth educationpatient education

Interventions

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Migrant farm workers (not available for the year-long program)
  • Pregnant
  • Medical conditions for which changes in diet and exercise levels would be contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78701, United States

Location

Related Publications (4)

  • 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.

    PMID: 7758387BACKGROUND
  • 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.

    PMID: 1448572BACKGROUND
  • 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.

    PMID: 10531848BACKGROUND
  • 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.

    PMID: 9677951BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Health Education

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Sharon A. Brown

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

March 13, 2000

First Posted

March 14, 2000

Study Start

September 1, 1999

Primary Completion

November 1, 2006

Study Completion

December 1, 2006

Last Updated

February 15, 2010

Record last verified: 2010-02

Locations