PREMIER: Lifestyle Interventions for Blood Pressure Control

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000616
First received: October 27, 1999
Last updated: May 8, 2006
Last verified: November 2005
  Purpose

To compare the effectiveness of advice versus two multicomponent lifestyle interventions to control blood pressure in participants with Stage 1 hypertension or higher than optimal blood pressure.


Condition Intervention Phase
Heart Diseases
Hypertension
Behavioral: diet, sodium-restricted
Behavioral: diet, fat-restricted
Behavioral: exercise
Behavioral: diet, reducing
Behavioral: alcohol drinking
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


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

Study Start Date: September 1998
Estimated Study Completion Date: August 2004
Detailed Description:

BACKGROUND:

A large body of data has been collected over the years documenting that on the one hand, reduced sodium intake, increased physical activity, weight loss, and moderate alcohol ingestion (Comprehensive Intervention) have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and Stage 1 hypertension. On the other hand, the Dietary Approaches to Stop Hypertension (DASH) study has shown that a diet rich in fruits, vegetables, low-fat dairy products, and decreased saturated fat, total fat, and cholesterol (DASH intervention) reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups.

DESIGN NARRATIVE:

A multicenter study to determine the BP-lowering effects of two multi-component lifestyle intervention programs compared with advice only. Eight hundred and ten men and women were randomly assigned to one of three treatment arms: (A) advice only; (B) comprehensive lifestyle intervention, in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for BP control (reduced salt intake, increased physical activity, reduced alcohol intake, and weight control or weight loss if needed); and (C) comprehensive lifestyle intervention plus the DASH diet, in which participants received a behavioral intervention program to promote the DASH dietary pattern in addition to the same lifestyle recommendations for BP control. Participants were followed for 18 months. The primary outcome variable was systolic blood pressure measured at six and 18 months after randomization. Other variables included diastolic blood pressure, dietary adherence, physical activity, and onset of hypertension over the 18 months of follow-up.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000616

Sponsors and Collaborators
Investigators
Investigator: Lawrence Appel Johns Hopkins University
Investigator: Pat Elmer Kaiser Foundation Research Institute
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000616     History of Changes
Other Study ID Numbers: 119
Study First Received: October 27, 1999
Last Updated: May 8, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Diseases
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 21, 2013