NCT00000616

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 1998

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

February 18, 2016

Status Verified

November 1, 2005

First QC Date

October 27, 1999

Last Update Submit

February 17, 2016

Conditions

Heart DiseasesHypertension

Interventions

diet, sodium-restrictedBEHAVIORAL
diet, fat-restrictedBEHAVIORAL
exerciseBEHAVIORAL
diet, reducingBEHAVIORAL
alcohol drinkingBEHAVIORAL

Eligibility Criteria

Age25 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (14)

  • 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. doi: 10.1001/jama.289.16.2083.

    PMID: 12709466BACKGROUND

  • 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. doi: 10.1001/jama.289.16.2131. No abstract available.

    PMID: 12709472BACKGROUND

  • 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. doi: 10.1016/s1047-2797(03)00006-1.

    PMID: 12875806BACKGROUND

  • 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. doi: 10.1111/j.1524-6175.2004.03147.x.

    PMID: 15249794BACKGROUND

  • 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. doi: 10.1038/sj.jhh.1001770.

    PMID: 15385946BACKGROUND

  • 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. doi: 10.1007/s10900-004-1095-7.

    PMID: 15810564BACKGROUND

  • 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. doi: 10.1007/s10865-005-4660-3.

    PMID: 16015458BACKGROUND

  • 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.

    PMID: 15825976BACKGROUND

  • 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 modification on diet, weight, physical fitness, and blood pressure control: 18-month results of a randomized trial. Ann Intern Med. 2006 Apr 4;144(7):485-95. doi: 10.7326/0003-4819-144-7-200604040-00007.

    PMID: 16585662RESULT

  • Lim YJ, van Dam RM. Impact of comprehensive lifestyle interventions on plasma branched-chain amino acid concentrations: a randomized trial. Am J Clin Nutr. 2025 Dec;122(6):1829-1835. doi: 10.1016/j.ajcnut.2025.10.008. Epub 2025 Oct 17.

    PMID: 41106729DERIVED

  • Gradinariu V, Ard J, van Dam RM. Effects of dietary quality, physical activity and weight loss on glucose homeostasis in persons with and without prediabetes in the PREMIER trial. Diabetes Obes Metab. 2023 Sep;25(9):2714-2722. doi: 10.1111/dom.15160. Epub 2023 Jun 13.

    PMID: 37311720DERIVED

  • McClure ST, Rebholz CM, Mitchell DC, Selvin E, Appel LJ. The association of dietary phosphorus with blood pressure: results from a secondary analysis of the PREMIER trial. J Hum Hypertens. 2020 Feb;34(2):132-142. doi: 10.1038/s41371-019-0231-x. Epub 2019 Aug 21.

    PMID: 31435005DERIVED

  • Chen L, Caballero B, Mitchell DC, Loria C, Lin PH, Champagne CM, Elmer PJ, Ard JD, Batch BC, Anderson CA, Appel LJ. Reducing consumption of sugar-sweetened beverages is associated with reduced blood pressure: a prospective study among United States adults. Circulation. 2010 Jun 8;121(22):2398-406. doi: 10.1161/CIRCULATIONAHA.109.911164. Epub 2010 May 24.

    PMID: 20497980DERIVED

  • Chen L, Appel LJ, Loria C, Lin PH, Champagne CM, Elmer PJ, Ard JD, Mitchell D, Batch BC, Svetkey LP, Caballero B. Reduction in consumption of sugar-sweetened beverages is associated with weight loss: the PREMIER trial. Am J Clin Nutr. 2009 May;89(5):1299-306. doi: 10.3945/ajcn.2008.27240. Epub 2009 Apr 1.

    PMID: 19339405DERIVED

Related Links

MeSH Terms

Conditions

Heart DiseasesHypertension

Interventions

Diet, Sodium-RestrictedDiet, Fat-RestrictedExerciseDiet, ReducingEthanol

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAlcoholsOrganic Chemicals

Study Officials

  • Lawrence Appel

    Johns Hopkins University

  • Pat Elmer

    Kaiser Foundation Research Institute

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

September 1, 1998

Study Completion

August 1, 2004

Last Updated

February 18, 2016

Record last verified: 2005-11