Study of Hispanics to Assess Risk Prevention in Prehypertension (SHARPP)

March 12, 2013 updated by: Maria Canossa Terris MD, Florida Heart Research Institute

Lifestyle Intervention in Multinational Hispanics With Prehypertension

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33137
        • Florida Heart Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Minimal Intervention Group
Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction.
Behavioral: Lifestyle modification
DASH diet and exercise advice
Other Names:
  • MIG
Behavioral: Lifestyle modification
DASH diet, exercise with systematic instruction by a dietician and/or coordinator
Other Names:
  • EIG
ACTIVE_COMPARATOR: Enhanced Intervention Group
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.
Behavioral: Lifestyle modification
DASH diet and exercise advice
Other Names:
  • MIG
Behavioral: Lifestyle modification
DASH diet, exercise with systematic instruction by a dietician and/or coordinator
Other Names:
  • EIG

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 6, 12 and 18 months
6, 12 and 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida Heart Research Institute

Investigators

  • Principal Investigator: Maria Canossa-Terris, MD, Florida Heart Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (ESTIMATE)

December 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2013

Last Update Submitted That Met QC Criteria

March 12, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHRI 2007-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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