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Prevention of Hypertension: A Randomized Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000495
Enrollment
Unknown
Registered
1999-10-28
Start date
1978-12-31
Completion date
Unknown
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

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.

Interventions

BEHAVIORALdiet, reducing
BEHAVIORALexercise

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Eligibility

Sex/Gender
ALL
Age
30 Years to 44 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026