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
  Purpose

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


Condition Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1989
Study Completion Date: March 1993
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.

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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000471

Sponsors and Collaborators
Investigators
Investigator: K. Gould University of Texas
Investigator: Dean Ornish University of California School of Medicine
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000471     History of Changes
Other Study ID Numbers: 60, R01HL042554
Study First Received: October 27, 1999
Last Updated: December 12, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Atherosclerosis
Vascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on September 18, 2014