Completed

Diabetes Self-Management Program for Mexican Americans

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Study Aim

This study aims to help you, as a Mexican American, prevent diabetes through a self-management program tailored to your cultural needs.

What is being tested

diabetes self-management education

Behavioral
Who is being recruted

Treatment Adherence and Compliance+11

+ Adherence Interventions

+ Behavior

From 35 to 70 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: September 1999
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: February 15, 2010
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00004983
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: February 15, 2010
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Treatment Adherence and ComplianceAdherence InterventionsBehaviorDiabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPatient Acceptance of Health CarePatient ComplianceHealth BehaviorGlucose Metabolism DisordersMedication AdherenceDiabetes Mellitus, Type 2Health Education

Criteria

3 inclusion criteria required to participate
A family member, preferably a spouse or first-degree relative, who agrees to participate

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

3 exclusion criteria prevent from participating
Medical conditions for which changes in diet and exercise levels would be contraindicated

Migrant farm workers (not available for the year-long program)

Pregnant

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The University of Texas at Austin

Austin, United StatesOpen The University of Texas at Austin in Google Maps
CompletedOne Study Center