Study of Hispanics to Assess Risk Prevention in Prehypertension

NCT01025323 | Terminated

• 1 other identifier: FHRI 2007-02
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Hypertension

Keywords

Pre hypertension; Lifestyle modification; DASH diet

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Minimal Intervention Group

ACTIVE COMPARATOR

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

Behavioral: Lifestyle modification

Enhanced Intervention Group

ACTIVE COMPARATOR

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

Interventions

Lifestyle modification BEHAVIORAL

DASH diet and exercise advice

Also known as: MIG

Minimal Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Heart Research Institute: lead

Study Sites (1)

Florida Heart Research Institute

Miami, Florida, 33137, United States

Location

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Maria Canossa-Terris, MD

  Florida Heart Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 3, 2009
• Study Start: December 1, 2007
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

US (1)