search
Back to results

Prevention of Hypertension: A Randomized Trial

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
diet, reducing
diet, sodium-restricted
alcohol restriction
exercise
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

30 Years - 44 Years (Adult)All SexesDoes not accept healthy volunteers

Men and women, ages 30 to 44. Normal high blood pressure of 80-89 mm Hg.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    November 21, 2014
    Sponsor
    Northwestern University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00000495
    Brief Title
    Prevention of Hypertension: A Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1978 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Northwestern University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine whether improved nutrition to correct overweight and high sodium intake, and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals.
    Detailed Description
    BACKGROUND: Diet modification is one of the strategies in the primary prevention of hypertension. Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures. The factors include overweight, alcohol consumption and high sodium intake. Heart rate is also an independent predictor of risk of hypertension. Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension. DESIGN NARRATIVE: In the first phase of the trial participants were randomized to a Monitored (Control) Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity. The goals of the Intervention Group were: a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight; a reduction in daily sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per day; and an increase in regular, moderate physical activity. The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group. In the second phase of the trial, all randomized participants were followed for a minimum of five years. The primary endpoints in the second phase were the incidence of high blood pressure and/or hypertension.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, reducing
    Intervention Type
    Behavioral
    Intervention Name(s)
    diet, sodium-restricted
    Intervention Type
    Behavioral
    Intervention Name(s)
    alcohol restriction
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women, ages 30 to 44. Normal high blood pressure of 80-89 mm Hg.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    6398983
    Citation
    Stamler R, Stamler J, Gosch FC, McDonald AM. Primary prevention of hypertension--a randomized controlled trial. Ann Clin Res. 1984;16 Suppl 43:136-42.
    Results Reference
    background
    PubMed Identifier
    2778913
    Citation
    Stamler R, Stamler J, Gosch FC, Civinelli J, Fishman J, McKeever P, McDonald A, Dyer AR. Primary prevention of hypertension by nutritional-hygienic means. Final report of a randomized, controlled trial. JAMA. 1989 Oct 6;262(13):1801-7. Erratum In: JAMA 1989 Dec 8;262(22):3132.
    Results Reference
    background

    Learn more about this trial

    Prevention of Hypertension: A Randomized Trial

    We'll reach out to this number within 24 hrs