Study of Hispanics to Assess Risk Prevention in Prehypertension

NCT ID: NCT01025323

Last Updated: 2013-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Pre-Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Minimal Intervention Group

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

Group Type: ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type: BEHAVIORAL

DASH diet and exercise advice

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.

Group Type: ACTIVE_COMPARATOR

Lifestyle modification

Intervention Type: BEHAVIORAL

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

Interventions

Lifestyle modification

DASH diet and exercise advice

Intervention Type: BEHAVIORAL

Lifestyle modification

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MIG; EIG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida Heart Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Maria Canossa Terris MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Canossa-Terris, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Heart Research Institute

Locations

Florida Heart Research Institute

Miami, Florida, United States

Countries

United States

Other Identifiers

FHRI 2007-02

Identifier Type: -

Identifier Source: org_study_id