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

December 2, 2009
March 12, 2013
December 2007
March 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01025323 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Study of Hispanics to Assess Risk Prevention in Prehypertension
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Pre-Hypertension
  • Behavioral: Lifestyle modification
    DASH diet and exercise advice
    Other Name: MIG
  • Behavioral: Lifestyle modification
    DASH diet, exercise with systematic instruction by a dietician and/or coordinator
    Other Name: EIG
  • Active Comparator: Minimal Intervention Group
    Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction.
    Intervention: Behavioral: Lifestyle modification
  • 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.
    Intervention: Behavioral: Lifestyle modification
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
58
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01025323
FHRI 2007-02
No
Maria Canossa Terris MD, Florida Heart Research Institute
Florida Heart Research Institute
Not Provided
Principal Investigator: Maria Canossa-Terris, MD Florida Heart Research Institute
Florida Heart Research Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP