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Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

This study has been terminated.
(PI left institution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583310
First Posted: December 31, 2007
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
American Heart Association
UNITE HERE Health Center
Information provided by (Responsible Party):
Tanya Spruill, Columbia University
  Purpose
Individuals with prehypertension are at risk for developing cardiovascular disease and sustained hypertension. Modifying lifestyle behaviors (diet, weight loss, sodium intake, physical activity, alcohol intake) has been shown to reduce blood pressure in hypertensives. Participants in this study will be enrolled in one of two groups. Participants in the first group will receive usual care, and participants in the second group will receive a 4 session telephone-based lifestyle intervention. The goal of the study is to determine whether this intervention is effective in promoting behavior change and reducing blood pressure among prehypertensives.

Condition Intervention Phase
High Blood Pressure Behavioral: Telephone-based lifestyle counseling Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients

Further study details as provided by Tanya Spruill, Columbia University:

Primary Outcome Measures:
  • Ambulatory blood pressure change [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Weight change [ Time Frame: 3 months ]
  • Change in dietary habits [ Time Frame: 6 weeks and 3 months ]
  • Change in physical activity level [ Time Frame: 6 weeks and 3 months ]

Enrollment: 125
Study Start Date: January 2007
Study Completion Date: July 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: 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.
Behavioral: 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.

Detailed Description:

Individuals with prehypertension are at increased cardiovascular risk compared with normotension, as well as increased risk of progression to sustained hypertension. The recommended treatment for prehypertension is lifestyle modification, including weight loss, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, reduction of dietary sodium, physical activity, and moderation of alcohol intake. The proposed pilot study will test the effect of a 4 session telephone-based lifestyle intervention on blood pressure change in 125 prehypertensive participants. The intervention includes education and behavioral counseling strategies that have been shown to be effective in promoting behavior change and reducing blood pressure among hypertensives.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Screening BP in prehypertensive range (SBP of 120-139 mmHg or DBP of 80-89 mmHg). If SBP or DBP is below these ranges, the patient is eligible. However, if either SBP or DBP is above the upper cutoffs (i.e., patient meets criteria for HTN), the patient will not be eligible.
  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:

  1. Patients who are currently taking anti-hypertensive medication will be excluded.
  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00583310


Locations
United States, New York
UNITE HERE Health Center
New York, New York, United States, 10001
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
New York University School of Medicine
American Heart Association
UNITE HERE Health Center
Investigators
Principal Investigator: Tanya M Goyal, PhD Columbia University
Principal Investigator: Matthew M Burg Columbia University
  More Information

Responsible Party: Tanya Spruill, Associate Clinical Professor, Department of Medicine Behavioral Cardiology, Columbia University
ClinicalTrials.gov Identifier: NCT00583310     History of Changes
Other Study ID Numbers: AAAC0714
First Submitted: December 20, 2007
First Posted: December 31, 2007
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by Tanya Spruill, Columbia University:
Prehypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases