Randomized Trial of Peer Led Education-Project Dulce

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peer-Led Diabetes Education Programs in High Risk Mexican Americans Evaluates Glycemic Control Compared to Standard Approaches: A Project Dulce™ Promotora Randomized Trial

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Peer Education
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>This arm continues with standard care at community clinic | Behavioral: Control<br>* This group continues with standard care at the community health center<br>|
| Experimental: Peer Education<br>This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months | Behavioral: Peer Education<br>* Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes<br>* Other names: Project Dulce;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean percent change Hemoglobin A1c (HbA1c) | Evaluate change in HbA1c over a 10 month time period from baseline. | Baseline, 4 months and 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index, blood pressure and lipid changes | Evaluate change in Body mass index, blood pressure and lipids over a 10 month time period from baseline | Baseline, 4 months and 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peer education, diabetes, randomized, trial