| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||||||
| Brief Title † | Lifestyle Heart Trial | ||||||||
| Official Title † | |||||||||
| Brief Summary | To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis. |
||||||||
| Detailed 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. |
||||||||
| Study Phase | Phase II | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Cardiovascular Diseases Coronary Arteriosclerosis Coronary Disease Heart Diseases Hypercholesterolemia Hypertension Myocardial Ischemia |
||||||||
| Intervention † | Behavioral: diet, vegetarianism Behavioral: diet, fat-restricted Behavioral: exercise Behavioral: smoking cessation |
||||||||
| MEDLINE PMIDs | 1973470, 1550011, 7674504 | ||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Completed | ||||||||
| Enrollment † | |||||||||
| Start Date † | April 1989 | ||||||||
| Completion Date | |||||||||
| Eligibility 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. |
||||||||
| Gender | Both | ||||||||
| Ages | 35 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | |||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000471 | ||||||||
| Organization ID | 60 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
|
||||||||
| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Verification Date | January 2000 | ||||||||
| First Received Date † | October 27, 1999 | ||||||||
| Last Updated Date | June 23, 2005 | ||||||||
|
