title: Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics.
abstract: OBJECTIVE
  To describe PREMIER, a randomized trial to determine the effects of multi-component lifestyle interventions on blood pressure (BP).
  
  
  METHODS
  Participants with above optimal BP through stage 1 hypertension were randomized to: 1) a behavioral lifestyle (BLS) intervention that implements established recommendations, 2) a BLS intervention that implements established recommendations plus the DASH diet, or 3) an advice only standard of care group. The two BLS interventions consist of group and individual counseling sessions for 18 months. The primary outcome is systolic BP at 6 months. Additional outcomes include diastolic BP and homocysteine at 6 months; systolic and diastolic BP at 18 months; fasting lipids, glucose and insulin at 6 and 18 months; and effects in subgroup.
  
  
  CONCLUSIONS
  Results from the PREMIER trial will provide scientific rationale for implementing multi-component behavioral lifestyle intervention programs to control BP and prevent CVD.
authors.affiliation: Duke Hypertension Center and Sarah W. Stedman Center for Nutritional Studies, Duke University Medical Center, Durham, NC, USA. svetk001@mc.duke.edu
authors.forename: Laura P
authors.initials: LP
authors.lastname: Svetkey
authors.forename: David W
authors.initials: DW
authors.lastname: Harsha
authors.forename: William M
authors.initials: WM
authors.lastname: Vollmer
authors.forename: Victor J
authors.initials: VJ
authors.lastname: Stevens
authors.forename: Eva
authors.initials: E
authors.lastname: Obarzanek
authors.forename: Patricia J
authors.initials: PJ
authors.lastname: Elmer
authors.forename: Pao Hwa
authors.initials: PH
authors.lastname: Lin
authors.forename: Catherine
authors.initials: C
authors.lastname: Champagne
authors.forename: Denise G
authors.initials: DG
authors.lastname: Simons-Morton
authors.forename: Mikel
authors.initials: M
authors.lastname: Aickin
authors.forename: Michael A
authors.initials: MA
authors.lastname: Proschan
authors.forename: Lawrence J
authors.initials: LJ
authors.lastname: Appel
mesh_terms: D001794:Blood Pressure; D004038:Diet, Reducing; D004039:Diet, Sodium-Restricted; D015444:Exercise; D005260:Female; D015438:Health Behavior; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D006973:Hypertension / Q000178:diet therapy / Q000517:prevention & control* / Q000523:psychology; D008019:Life Style; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D010349:Patient Compliance; D040242:Risk Reduction Behavior; D014481:United States