PREMIER: Lifestyle Interventions for Blood Pressure Control
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|ClinicalTrials.gov Identifier: NCT00000616|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 18, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Hypertension||Behavioral: diet, sodium-restricted Behavioral: diet, fat-restricted Behavioral: exercise Behavioral: diet, reducing Behavioral: alcohol drinking||Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||September 1998|
|Actual Study Completion Date :||August 2004|
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|Ages Eligible for Study:||25 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000616
|OverallOfficial:||Lawrence Appel||Johns Hopkins University|
|OverallOfficial:||Pat Elmer||Kaiser Foundation Research Institute|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Other Study ID Numbers:||
U01HL060574 ( U.S. NIH Grant/Contract )
|First Posted:||October 28, 1999 Key Record Dates|
|Last Update Posted:||February 18, 2016|
|Last Verified:||November 2005|