Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000471
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Lifestyle Heart Trial
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The study completion date listed in this record was obtained from the QueryViewReport QVR System
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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL042554 | NIH | None | httpsreporternihgovquickSearchR01HL042554 |