Lifestyle Intervention in Multinational Hispanics With Prehypertension
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| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33137 |
| Conditions: |
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Pre-Hypertension |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- Hispanic men and women age 18 or older
- Mean baseline SBP 130-139 mmHg and DBP 85-89 mmHg on screening visits 1&2
- Subjects who have access to a telephone
- Subjects who have read, signed and received a copy of the informed consent form prior
to the initiation of any study procedures and who agree to participate in all aspects
of the study
- Subjects who are willing and capable of complying with the requirements of the study
Exclusion Criteria:
- BMI > 35
- Pregnant or breast feeding
- Currently taking any anti-hypertensive medications
- History of cardiovascular disease (Stroke, MI, PCI, CABG)
- Current symptoms of angina or peripheral vascular disease by Rose questionnaire
- Fasting glucose ≥ 126mg/dl) or a history of diabetes and use of antidiabetic
medication
- Use of oral corticosteroids > 5days/month on average
- Consumption of more than 21 alcoholic drinks per week or consumption of 6 or more
drinks on one occasion twice or more per week in the past 3 months prior to screening
visit
- Use of weight loss medications (prescription or over the counter) in the past 3
months prior to screening visit 1 or body weight change > 15 pounds in the 3 months
prior to screening visit
- Currently undergoing or planning to undergo treatment for a neoplastic disease
- Clinical significant laboratory test results that are indicative of a serious medical
condition
- Renal Insufficiency (GFR<60ml/min as estimated using Cockcroft -Gault formula)
- Any orthopedic or rheumatologic problems that might limit a subject's ability to
participate in the physical activity component of the intervention
- Any medical condition which in the judgment of the Investigator places the subject at
risk due to his/her participation in the study, is likely to prevent the subject from
complying with the requirements of the study or completing the study or which may
jeopardize the evaluation of efficacy or safety
- Planning to leave area prior to the anticipated end of participation
- Current participation in another research study
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| NCT ID: |
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NCT01025323 |
| Primary Contact: |
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Principal Investigator
Maria Canossa-Terris, MD
Florida Heart Research Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Miami, Florida 33137
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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