PREMIER: Lifestyle Interventions for Blood Pressure Control

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000616
• Other study ID #: 119
• Secondary ID: U01HL060574
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: February 17, 2016
• Start date: September 1998
• Est. completion date: August 2004

Study information

• Verified date: November 2005
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 100 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Diseases
• Hypertension

Intervention

Behavioral:
• diet, sodium-restricted

• diet, fat-restricted

• exercise

• diet, reducing

• alcohol drinking

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

Elmer PJ, Obarzanek E, Vollmer WM, Simons-Morton D, Stevens VJ, Young DR, Lin PH, Champagne C, Harsha DW, Svetkey LP, Ard J, Brantley PJ, Proschan MA, Erlinger TP, Appel LJ; PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modifica — View Citation

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. Erratum in: J Clin Hypertens (Greenwich). 2004 Oct;6(10):568. Elmer, Patrick J [corrected to Elmer, Patricia J]. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation