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Lifestyle Heart Trial

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000471
First received: October 27, 1999
Last updated: December 12, 2013
Last verified: January 2000

October 27, 1999
December 12, 2013
April 1989
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Complete list of historical versions of study NCT00000471 on ClinicalTrials.gov Archive Site
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Lifestyle Heart Trial
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To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

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.

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

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Prevention
  • Cardiovascular Diseases
  • Coronary Arteriosclerosis
  • Coronary Disease
  • Heart Diseases
  • Hypercholesterolemia
  • Hypertension
  • Myocardial Ischemia
  • Behavioral: diet, vegetarianism
  • Behavioral: diet, fat-restricted
  • Behavioral: exercise
  • Behavioral: smoking cessation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 1993
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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.

Both
35 Years to 75 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT00000471
60, R01HL042554
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: K. Gould University of Texas
Investigator: Dean Ornish University of California School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
January 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP