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| ID | Type | Description | Link |
|---|---|---|---|
| U54RR026140-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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The purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.
In recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. Among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-Hispanic White females. Non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. Often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities.
This study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). Participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Education and patient liaison combination |
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| Control group | Experimental | Education only |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and patient liaison combination | Behavioral | Group education sessions with Patient liaison using ecological momentary assessment principles |
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | glycosylated hemoglobin | baseline, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors for co-morbidity and daily self-management behaviors |
| baseline, 3, 6, 9 and 12 months |
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Inclusion Criteria:
Low-income women ages 21 and older; With type 2 diabetes ( fasting plasma glucose > 126 mg/dl);
At risk of developing diabetes related complications (treatments goals from The American Diabetes Association Standards of medical care) as defined by:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie A Akohoue, PhD | Meharry Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meharry medical College | Nashville | Tennessee | 37208 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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| Control group | Behavioral | Group education sessions at baseline, 3 and 6 months |
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| D004700 | Endocrine System Diseases |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |