Clinical trial NCT01025323: Study of Hispanics to Assess Risk Prevention in Prehypertension
Official title: Lifestyle Intervention in Multinational Hispanics With Prehypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Hypertension
Keywords: Pre hypertension
Lifestyle modification
DASH diet
Lead sponsor: Florida Heart Research Institute
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida Heart Research Institute
state: Florida
Study officials:
affiliation: Florida Heart Research Institute
name: Maria Canossa-Terris, MD
role: PRINCIPAL_INVESTIGATOR
References: