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Trial NCT00000616

Resource URI: http://static.linkedct.org/resource/trials/NCT00000616
linkedct:brief_title PREMIER: Lifestyle Interventions for Blood Pressure Control
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:criteria Men and women, age 25 and older who were generally healthy except for higher than optimal or mildly elevated blood pressure.
linkedct:description BACKGROUND: 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. DESIGN NARRATIVE: 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 25 Years
linkedct:end_date August 2004
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000616
rdfs:label Trial NCT00000616
linkedct:lastchanged_date May 8, 2006
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000616
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 119
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/34487>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/45223>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000616>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/17095>
linkedct:reference <http://static.linkedct.org/resource/reference/17097>
linkedct:reference <http://static.linkedct.org/resource/reference/18140>
linkedct:reference <http://static.linkedct.org/resource/reference/23009>
linkedct:reference <http://static.linkedct.org/resource/reference/23847>
linkedct:reference <http://static.linkedct.org/resource/reference/26319>
linkedct:reference <http://static.linkedct.org/resource/reference/26417>
linkedct:reference <http://static.linkedct.org/resource/reference/27717>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/5853>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1998
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date November 2005