Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000616
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
PREMIER Lifestyle Interventions for Blood Pressure Control
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:
2005-11
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 compare the effectiveness of advice versus two multicomponent lifestyle interventions to control blood pressure in participants with Stage 1 hypertension or higher than optimal blood pressure
Detailed Description:
BACKGROUND
A large body of data has been collected over the years documenting that on the one hand reduced sodium intake increased physical activity weight loss and moderate alcohol ingestion Comprehensive Intervention have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and Stage 1 hypertension On the other hand the Dietary Approaches to Stop Hypertension DASH study has shown that a diet rich in fruits vegetables low-fat dairy products and decreased saturated fat total fat and cholesterol DASH intervention reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups
DESIGN NARRATIVE
A multicenter study to determine the BP-lowering effects of two multi-component lifestyle intervention programs compared with advice only Eight hundred and ten men and women were randomly assigned to one of three treatment arms A advice only B comprehensive lifestyle intervention in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for BP control reduced salt intake increased physical activity reduced alcohol intake and weight control or weight loss if needed and C comprehensive lifestyle intervention plus the DASH diet in which participants received a behavioral intervention program to promote the DASH dietary pattern in addition to the same lifestyle recommendations for BP control Participants were followed for 18 months The primary outcome variable was systolic blood pressure measured at six and 18 months after randomization Other variables included diastolic blood pressure dietary adherence physical activity and onset of hypertension over the 18 months of follow-up
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
A large body of data has been collected over the years documenting that on the one hand reduced sodium intake increased physical activity weight loss and moderate alcohol ingestion Comprehensive Intervention have been associated with a modest reduction of both systolic and diastolic blood pressure in with high normal and Stage 1 hypertension On the other hand the Dietary Approaches to Stop Hypertension DASH study has shown that a diet rich in fruits vegetables low-fat dairy products and decreased saturated fat total fat and cholesterol DASH intervention reduced both diastolic and systolic blood pressure in similar baseline blood pressure groups
DESIGN NARRATIVE
A multicenter study to determine the BP-lowering effects of two multi-component lifestyle intervention programs compared with advice only Eight hundred and ten men and women were randomly assigned to one of three treatment arms A advice only B comprehensive lifestyle intervention in which participants received an intensive behavioral intervention program to facilitate achieving current lifestyle recommendations for BP control reduced salt intake increased physical activity reduced alcohol intake and weight control or weight loss if needed and C comprehensive lifestyle intervention plus the DASH diet in which participants received a behavioral intervention program to promote the DASH dietary pattern in addition to the same lifestyle recommendations for BP control Participants were followed for 18 months The primary outcome variable was systolic blood pressure measured at six and 18 months after randomization Other variables included diastolic blood pressure dietary adherence physical activity and onset of hypertension over the 18 months of follow-up
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| U01HL060574 | NIH | None | httpsreporternihgovquickSearchU01HL060574 |