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 and November The trial was supported prior to April from various sources other than the National Heart, Lung, and Blood Institute.
Follow-up continued for four years. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies 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. Patients who participated in the 12 week Ornish program showed statistically significant improvements in their total cholesterol, LDL cholesterol, and triglycerides. Patients who followed the Ornish program lowered their systolic and diastolic blood pressure after only 12 weeks, and many were able to decrease their blood pressure medication.
Our research showed that patients with depression and metabolic syndrome were able to make significant intensive diet and lifestyle changes. We examined baseline and 3 month medical and psychosocial characteristics of women and men enrolled in the Multi-center Lifestyle Demonstration Project.
Results showed significant improvements in diet, exercise and stress management, as well as improvements in medical and psychosocial characteristics. These improvements occured in spite of gender differences in medical, psychosocial and sociodemographic status.
These results suggest that programs focusing on intensive lifestyle changes can be successfully implemented in diverse regions of the United States, and may be particularly helpful for women with heart disease, who generally have higher mortality and morbidity rates than men after a cardiac event. We examined the potential of intensive lifestyle changes as a direct alternative to revascularization procedures on patients enrolled in the Multi-center Lifestyle Demonstration Project.
Results showed that patients in the experimental group were able to avoid revascularization for at least 3 years without increasing cardiac morbidity and mortality. These changes also came at a significantly lower cost than a revascularization procedure. These patients also reported experiencing reductions in angina similar to what was reported after a revascularization.
In conclusion, we have evaluated the Ornish program from a variety of different approaches with very similar conclusion. That is, the evidence to date supports the presumption that comprehensive lifestyle changes for the treatment of CAD save money, as well as improve the clinical status of the patient.
February, The New England Journal of Medicine Initial coronary stent implantation with medical therapy vs medical therapy alone for stable coronary artery disease: meta-analysis of randomized controlled trials. April 1, The New England Journal of Medicine Effect of nateglinide on the incidence of diabetes and cardiovascular events. Setting: Two tertiary care university medical centers. Main outcome measures: Adherence to intensive lifestyle changes, changes in coronary artery percent diameter stenosis, and cardiac events.
In the experimental group, the average percent diameter stenosis at baseline decreased 1. In contrast, the average percent diameter stenosis in the control group increased by 2. Twenty-five cardiac events occurred in 28 experimental group patients vs 45 events in 20 control group patients during the 5-year follow-up risk ratio for any event for the control group, 2.
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