Clinical Trials Directory

Trials / Completed

CompletedNCT00848315

Diabetes Management in Low-Income Hispanic Patients

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
252 (actual)
Sponsor
University of Massachusetts, Worcester · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The overall goal of this randomized clinical trial (RCT) is to test the efficacy of a culturally- and literacy-tailored cognitive-behavioral intervention designed to enhance adherence to diabetes self-management behaviors and improve glycemic control among low-income Hispanic individuals with type 2 diabetes mellitus.

Detailed description

Patients are randomly assigned to a Usual Care condition or to the Cognitive Behavioral Intervention condition. The unit of randomization and analysis is the patient. The intervention is implemented by a nutritionist, a nurse diabetes educator and an assistant, and patients are encouraged to bring a family member or friend living in the same household to facilitate home-based support for the intervention. The intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate pts.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCognitive Behavioral InterventionThe intervention emphasizes patients' ethnic preferences and traditions (e.g., adapting ethnic recipes to meet dietary goals) and the use of available community resources (e.g., available areas for exercise), and is delivered utilizing strategies and materials appropriate for low-literate/illiterate patients.

Timeline

Start date
2004-07-01
Primary completion
2008-06-01
Completion
2008-07-01
First posted
2009-02-20
Last updated
2023-09-13

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00848315. Inclusion in this directory is not an endorsement.