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PREMIER: Lifestyle Interventions for Blood Pressure Control
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: NCT00000616
  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 III

MedlinePlus related topics: Alcohol Consumption Heart Diseases High Blood Pressure Weight Control
Drug Information available for: Ethanol
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized

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

Related Info  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, Stedman SW, Young DR; Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA. 2003 Apr 23-30;289(16):2083-93.
Pickering TG. Lifestyle modification and blood pressure control: is the glass half full or half empty? JAMA. 2003 Apr 23-30;289(16):2131-2. No abstract available.
Svetkey LP, Harsha DW, Vollmer WM, Stevens VJ, Obarzanek E, Elmer PJ, Lin PH, Champagne C, Simons-Morton DG, Aickin M, Proschan MA, Appel LJ. Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics. Ann Epidemiol. 2003 Jul;13(6):462-71.
McGuire HL, Svetkey LP, Harsha DW, Elmer PJ, Appel LJ, Ard JD. Comprehensive lifestyle modification and blood pressure control: a review of the PREMIER trial. J Clin Hypertens (Greenwich). 2004 Jul;6(7):383-90.
Svetkey LP, Erlinger TP, Vollmer WM, Feldstein A, Cooper LS, Appel LJ, Ard JD, Elmer PJ, Harsha D, Stevens VJ. Effect of lifestyle modifications on blood pressure by race, sex, hypertension status, and age. J Hum Hypertens. 2005 Jan;19(1):21-31.
Young DR, Aickin M, Brantley P, Elmer PJ, Harsha DW, King AC, Stevens VJ. Physical activity, cardiorespiratory fitness, and their relationship to cardiovascular risk factors in African Americans and non-African Americans with above-optimal blood pressure. J Community Health. 2005 Apr;30(2):107-24.
Ard JD, Skinner CS, Chen C, Aickin M, Svetkey LP. Informing cancer prevention strategies for African Americans: the relationship of African American acculturation to fruit, vegetable, and fat intake. J Behav Med. 2005 Jun;28(3):239-47.
Ard JD, Durant RW, Edwards LC, Svetkey LP. Perceptions of African-American culture and implications for clinical trial design. Ethn Dis. 2005 Spring;15(2):292-9.

Study ID Numbers: 119
Study First Received: October 27, 1999
Last Updated: May 8, 2006
ClinicalTrials.gov Identifier: NCT00000616  
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 13, 2009