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

Primary Purpose

High Blood Pressure

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telephone-based lifestyle counseling
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for High Blood Pressure focused on measuring Prehypertension

Eligibility Criteria

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

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.

Sites / Locations

  • UNITE HERE Health Center
  • Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Ambulatory blood pressure change

Secondary Outcome Measures

Weight change
Change in dietary habits
Change in physical activity level

Full Information

First Posted
December 20, 2007
Last Updated
November 18, 2013
Sponsor
NYU Langone Health
Collaborators
American Heart Association, UNITE HERE Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT00583310
Brief Title
Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients
Official Title
Telephone-Based Lifestyle Intervention to Reduce Blood Pressure in Prehypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NYU Langone Health
Collaborators
American Heart Association, UNITE HERE Health Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Blood Pressure
Keywords
Prehypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-based lifestyle counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ambulatory blood pressure change
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight change
Time Frame
3 months
Title
Change in dietary habits
Time Frame
6 weeks and 3 months
Title
Change in physical activity level
Time Frame
6 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Able to read and communicate in English or Spanish. Must have access to a telephone at home or at work. Age 18 years or older Exclusion Criteria: Patients who are currently taking anti-hypertensive medication will be excluded. 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. Patients who are currently participating in another HTN-related clinical trial will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya M Goyal, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew M Burg
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNITE HERE Health Center
City
New York
State/Province
New York
ZIP/Postal Code
10001
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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