Lifestyle Heart Trial
|ClinicalTrials.gov Identifier: NCT00000471|
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : December 13, 2013
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Study Start Date :||April 1989|
|Study Completion Date :||March 1993|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000471
|OverallOfficial:||K. Gould||University of Texas|
|OverallOfficial:||Dean Ornish||University of California School of Medicine|