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| ID | Type | Description | Link |
|---|---|---|---|
| R18DK070666-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
| San Diego State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | This arm continues with standard care at community clinic |
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| Peer Education | Experimental | This group receives 8 weeks of peer led self management education classes and subsequent monthly support groups for a total of 10 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Education | Behavioral | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Athena Philis-Tsimikas, MD | Scripps Whittier Diabetes Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | La Jolla | California | 92037 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Control | Behavioral | This group continues with standard care at the community health center |
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