NCT00583310

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

3.1 years

First QC Date

December 20, 2007

Last Update Submit

November 18, 2013

Conditions

High Blood Pressure

Keywords

Prehypertension

Outcome Measures

Primary Outcomes (1)

  • Ambulatory blood pressure change

    3 months

Secondary Outcomes (3)

  • Weight change

    3 months

  • Change in dietary habits

    6 weeks and 3 months

  • Change in physical activity level

    6 weeks and 3 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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

Interventions

Telephone-based lifestyle counselingBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UNITE HERE Health Center

New York, New York, 10001, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HypertensionPrehypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tanya M Goyal, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

  • Matthew M Burg

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor, Department of Medicine Behavioral Cardiology

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2010

Study Completion

July 1, 2012

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

US(2)