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

Primary Purpose

Pre-Hypertension

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Lifestyle modification

About this trial

This is an interventional prevention trial for Pre-Hypertension focused on measuring Pre hypertension, Lifestyle modification, DASH diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Florida Heart Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Minimal Intervention Group

Enhanced Intervention Group

Arm Description

Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction.

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.

Outcomes

Primary Outcome Measures

To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group

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

Full Information

NCT ID

NCT01025323

First Posted

December 2, 2009

Last Updated

March 12, 2013

Sponsor

Florida Heart Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01025323

Brief Title

Study of Hispanics to Assess Risk Prevention in Prehypertension

Acronym

SHARPP

Official Title

Lifestyle Intervention in Multinational Hispanics With Prehypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Terminated

Why Stopped

The study was terminated due to difficult recruitment and retention of subjects, these were attributed by subjects to conflict with their job schedule.

Study Start Date

December 2007 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Florida Heart Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-Hypertension

Keywords

Pre hypertension, Lifestyle modification, DASH diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Minimal Intervention Group

Arm Type

Active Comparator

Arm Description

Participants in this arm receive advice and printed guidelines but no counseling or systematic instruction.

Arm Title

Enhanced Intervention Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle modification

Other Intervention Name(s)

MIG

Intervention Description

DASH diet and exercise advice

Intervention Type

Behavioral

Intervention Name(s)

Lifestyle modification

Other Intervention Name(s)

EIG

Intervention Description

DASH diet, exercise with systematic instruction by a dietician and/or coordinator

Primary Outcome Measure Information:

Title

To test the effect on systolic blood pressure on the Enhanced Intervention Group compared to the Minimal Intervention Group

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Time Frame

6, 12 and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Canossa-Terris, MD

Organizational Affiliation

Florida Heart Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Florida Heart Research Institute

City

Miami

State/Province

Florida

ZIP/Postal Code

33137

Country

United States

12. IPD Sharing Statement

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