Clinical Trial: Study of Hispanics to Assess Risk Prevention in Prehypertension

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Lifestyle Intervention in Multinational Hispanics With Prehypertension

Brief Summary: The purpose of this study is to assess the efficacy of lifestyle modification in reducing blood pressure values in Hispanics at risk for hypertension.

Detailed Summary:

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.

Sponsor: Florida Heart Research Institute

Current Primary Outcome: To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 [ Time Frame: 6, 12 and 18 months ]

Original Secondary Outcome: Same as current

Information By: Florida Heart Research Institute

Dates:
Date Received: December 2, 2009
Date Started: December 2007
Date Completion:
Last Updated: March 12, 2013
Last Verified: March 2013