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Trial NCT00000471

Resource URI: http://static.linkedct.org/resource/trials/NCT00000471
linkedct:brief_title Lifestyle Heart Trial
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3361>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6173>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.
linkedct:description BACKGROUND: The trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone. DESIGN NARRATIVE: Patients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years.
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 75 Years
linkedct:eligibility_minimum_age 35 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000471
rdfs:label Trial NCT00000471
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000471
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 60
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/13212>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/31409>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000471>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/24265>
linkedct:reference <http://static.linkedct.org/resource/reference/37717>
linkedct:reference <http://static.linkedct.org/resource/reference/45682>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date April 1989
linkedct:study_design Prevention, Randomized
linkedct:study_type Interventional
linkedct:summary To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.
rdf:type linkedct:trials
linkedct:verification_date January 2000