Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Scripps Whittier Diabetes Institute
- Enrollment
- 207
- Locations
- 1
- Primary Endpoint
- mean percent change Hemoglobin A1c (HbA1c)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the effect of a culturally sensitive diabetes self-management program on glucose control and metabolic parameters in low income Mexican-Americans with type 2 diabetes using the Project Dulce model utilizing a low cost, peer-educator format.
Detailed Description
To recruit 207 Mexican-Americans patients from federally-funded community health centers in San Diego County with Hemoglobin A1c (HbA1c) \> 8% and randomize to Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome will be the percent change in HbA1c levels at 10 months following randomization.
Investigators
Athena Philis-Tsimikas
Corp VP
Scripps Whittier Diabetes Institute
Eligibility Criteria
Inclusion Criteria
- •Mexican American, men and women, 21-75 years old, who were under-insured patients at federally qualified community health centers in San Diego County with type 2 diabetes and HbA1c \> or = 8%.
Exclusion Criteria
- •Individuals with a physical or mental health condition that would preclude fulfilling the requirements of the study were ineligible to participate, HbA1c \< 8,pregnant with gestational diabetes
Outcomes
Primary Outcomes
mean percent change Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 4 months and 10 months
Evaluate change in HbA1c over a 10 month time period from baseline.
Secondary Outcomes
- Body mass index, blood pressure and lipid changes(Baseline, 4 months and 10 months)