This clinical center application is part of a set of applications from five participating institutions. PREMIER, a randomized clinical trial, will determine how two multi-component lifestyle interventions affect blood pressure (BP). Although numerous organizations recommend lifestyle change to control BP and potentially prevent hypertension, practical implementation strategies have yet to be developed and tested. The two lifestyle interventions to be tested in PREMIER include a """"""""comprehensive"""""""" intervention implementing current recommendations for BP control (reduced salt intake; increased physical activity; moderation of alcohol intake; and weight loss, if appropriate), and a """"""""comprehensive plus DASH"""""""" intervention implementing current recommendations plus the Dietary Approaches to Stop Hypertension (DASH) dietary pattern (rich in fruits, vegetables, and low fat dairy products, and reduced in saturated fat, total fat, and cholesterol). These lifestyle intervention programs will consist of a series of group and individual counseling sessions similar in intensity to health education programs currently provided by health care delivery systems for other conditions. Study participants (n=800) will be 25 years of age or older, with systolic BP of 120 159 mmHg and diastolic BP of 80 95 mmHg. Approximately half of the participants will be female, 40 percent will be African American, and 30 percent will have stage 1 hypertension. After three screening visits, participants will be randomly assigned to one of the two lifestyle interventions or a usual care control group. Follow up will last 18 months after randomization. The primary outcome will be systolic BP with diastolic BP as a secondary outcome. Additional outcome variables will include fasting lipids, fasting glucose, insulin, and homocysteine. The trial hypotheses will be examined in all participants as well as separately in non hypertensive and hypertensive subgroups. Results from PREMIER will provide the scientific rationale for routinely implementing comprehensive lifestyle intervention programs to control BP and ultimately prevent BP related cardiovascular disease.
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