Premier: a clinical trial of comprehensive lifestyle modification for blood pressure control: rationale, design and baseline characteristics.
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.
Svetkey
Laura P
LP
Duke Hypertension Center and Sarah W. Stedman Center for Nutritional Studies, Duke University Medical Center, Durham, NC, USA. svetk001@mc.duke.edu
Harsha
David W
DW
Vollmer
William M
WM
Stevens
Victor J
VJ
Obarzanek
Eva
E
Elmer
Patricia J
PJ
Lin
Pao Hwa
PH
Champagne
Catherine
C
Simons-Morton
Denise G
DG
Aickin
Mikel
M
Proschan
Michael A
MA
Appel
Lawrence J
LJ
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