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The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.
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The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.
In this study participants (who have prehypertension as defined as systolic blood pressure - the upper number- 130-139 mmHg and diastolic blood pressure 85-89mmHg- the lower number-) are randomly assigned to one of two groups:
the Minimal Intervention Group- participants receive advice and printed guidelines only but no counseling or personalized instruction, or the Enhanced Intervention Group- participants receive advice and the same printed guidelines as the minimal intervention group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and personalized instructions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal Intervention Group | Active Comparator | Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction. |
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| Enhanced Intervention Group | Active Comparator | Participants in this group receive advice and the same printed guidelines as the Minimal Intervention Group, together with dietary and physical activity counseling provided by a dietician and/or coordinator, periodic professional reviews of their progress and systematic instruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle modification | Behavioral | DASH diet and exercise advice |
|
| Measure | Description | Time Frame |
|---|---|---|
| To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The test the effect on systolic and diastolic blood pressure,lipid profile, glucose level, c-reactive protein and body mass index of the Enhanced Intervention Group in comparison to the Minimal Intervention Group | 6, 12 and 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Canossa-Terris, MD | Florida Heart Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Heart Research Institute | Miami | Florida | 33137 | United States |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Lifestyle modification | Behavioral | DASH diet, exercise with systematic instruction by a dietician and/or coordinator |
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