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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

October 27, 1999
May 8, 2006
September 1998
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Complete list of historical versions of study NCT00000616 on ClinicalTrials.gov Archive Site
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PREMIER: Lifestyle Interventions for Blood Pressure Control
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Prevention
  • Heart Diseases
  • Hypertension
  • Behavioral: diet, sodium-restricted
  • Behavioral: diet, fat-restricted
  • Behavioral: exercise
  • Behavioral: diet, reducing
  • Behavioral: alcohol drinking
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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August 2004
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Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.

Both
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00000616
119
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Lawrence Appel Johns Hopkins University
Investigator: Pat Elmer Kaiser Foundation Research Institute
National Heart, Lung, and Blood Institute (NHLBI)
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP