Study of Hispanics to Assess Risk Prevention in Prehypertension

Pre-Hypertension Clinical Trial

— SHARPP  

Official title:

Lifestyle Intervention in Multinational Hispanics With Prehypertension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01025323
• Other study ID #: FHRI 2007-02
• Status: Terminated
• Phase: N/A
• First received: December 2, 2009
• Last updated: March 12, 2013
• Start date: December 2007
• Est. completion date: March 2013

Study information

• Verified date: March 2013
• Source: Florida Heart Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Hypertension
• Prehypertension

Intervention

Behavioral:
• Lifestyle modification
DASH diet and exercise advice
• Lifestyle modification
DASH diet, exercise with systematic instruction by a dietician and/or coordinator

Locations

Country	Name	City	State
United States	Florida Heart Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Heart Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group		6 months	No
Secondary	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		6, 12 and 18 months	No