Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients
NCT ID: NCT00583310
Last Updated: 2013-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
125 participants
INTERVENTIONAL
2007-01-31
2012-07-31
Brief Summary
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Detailed Description
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Following baseline assessment, participants will be randomized to the intervention or usual care, and will complete follow-up assessments at 6 weeks and 3 months post-randomization. The primary aim of the study is to examine the effect of the intervention on blood pressure at 3 months. Secondary aims include examining intervention effects on lifestyle behavior changes at 6 weeks and 3 months. This study will provide pilot and feasibility data for a future application to study effects of the intervention on risk factor modification, blood pressure reduction, and cardiovascular morbidity and mortality. If successful, this brief, cost-effective intervention could easily be incorporated into routine care, and could have a significant impact on the management of prehypertension.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Subjects receive standard written educational information at baseline, but do not receive the telephone-based intervention. Subjects may participate in the intervention following completion of the study.
No interventions assigned to this group
Intervention
Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.
Telephone-based lifestyle counseling
Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.
Interventions
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Telephone-based lifestyle counseling
Four 30-minute telephone sessions including education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure.
Eligibility Criteria
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Inclusion Criteria
2. Able to read and communicate in English or Spanish.
3. Must have access to a telephone at home or at work.
4. Age 18 years or older
Exclusion Criteria
2. Patients with diabetes or kidney disease will be excluded, because pharmacologic treatment may be initiated to achieve the JNC 7 recommended BP goal of 130/80 mmHg in patients with these compelling indications.
3. Patients who are currently participating in another HTN-related clinical trial will be excluded.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
UNITE HERE Health Center
UNKNOWN
NYU Langone Health
OTHER
Responsible Party
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Tanya Spruill
Associate Clinical Professor, Department of Medicine Behavioral Cardiology
Principal Investigators
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Tanya M Goyal, PhD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Matthew M Burg
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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UNITE HERE Health Center
New York, New York, United States
Columbia University
New York, New York, United States
Countries
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Other Identifiers
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AAAC0714
Identifier Type: -
Identifier Source: org_study_id