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

This study has been terminated.
(The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.)
Sponsor:
Information provided by (Responsible Party):
Maria Canossa Terris MD, Florida Heart Research Institute
ClinicalTrials.gov Identifier:
NCT01025323
First received: December 2, 2009
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Pre-Hypertension
Behavioral: Lifestyle modification

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Lifestyle Intervention in Multinational Hispanics With Prehypertension

Resource links provided by NLM:


Further study details as provided by Florida Heart Research Institute:

Primary Outcome Measures:
  • To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: December 2007
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: MIG
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, exercise with systematic instruction by a dietician and/or coordinator
Other Name: EIG

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025323

Locations
United States, Florida
Florida Heart Research Institute
Miami, Florida, United States, 33137
Sponsors and Collaborators
Florida Heart Research Institute
Investigators
Principal Investigator: Maria Canossa-Terris, MD Florida Heart Research Institute
  More Information

No publications provided

Responsible Party: Maria Canossa Terris MD, Medical Director, Florida Heart Research Institute
ClinicalTrials.gov Identifier: NCT01025323     History of Changes
Other Study ID Numbers: FHRI 2007-02
Study First Received: December 2, 2009
Last Updated: March 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Heart Research Institute:
Pre hypertension
Lifestyle modification
DASH diet

Additional relevant MeSH terms:
Hypertension
Prehypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014