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Lifestyle Heart Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000471
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : December 13, 2013
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Hypercholesterolemia Hypertension Myocardial Ischemia Behavioral: diet, vegetarianism Behavioral: diet, fat-restricted Behavioral: exercise Behavioral: smoking cessation Phase 2

Detailed Description:


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.


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.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : April 1989
Actual Study Completion Date : March 1993

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00000471

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: K. Gould University of Texas
OverallOfficial: Dean Ornish University of California School of Medicine
Layout table for additonal information Identifier: NCT00000471    
Other Study ID Numbers: 60
R01HL042554 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: January 2000
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases