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Prevention of Hypertension: A Randomized Trial
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000495
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Behavioral: diet, reducing
Behavioral: diet, sodium-restricted
Behavioral: alcohol restriction
Behavioral: exercise
Phase III

MedlinePlus related topics: Dietary Sodium Exercise and Physical Fitness Heart Diseases High Blood Pressure Vascular Diseases Weight Control
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Parallel Assignment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: December 1978
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.

  Eligibility

Ages Eligible for Study:   30 Years to 44 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study ID Numbers: 14
Study First Received: October 27, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000495  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Vascular Diseases
Ethanol
Hypertension

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009