Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000495
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
1999-10-27
Brief Title:
Prevention of Hypertension A Randomized Trial
Sponsor:
Northwestern University
Organization:
Northwestern University
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 determine whether improved nutrition to correct overweight and high sodium intake and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals
Detailed Description:
BACKGROUND
Diet modification is one of the strategies in the primary prevention of hypertension Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures The factors include overweight alcohol consumption and high sodium intake Heart rate is also an independent predictor of risk of hypertension Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension
DESIGN NARRATIVE
In the first phase of the trial participants were randomized to a Monitored Control Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity The goals of the Intervention Group were a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight a reduction in daily sodium intake to 1800 mg a modification of alcohol intake to no more than two drinks per day and an increase in regular moderate physical activity The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group In the second phase of the trial all randomized participants were followed for a minimum of five years The primary endpoints in the second phase were the incidence of high blood pressure andor hypertension
Diet modification is one of the strategies in the primary prevention of hypertension Studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures The factors include overweight alcohol consumption and high sodium intake Heart rate is also an independent predictor of risk of hypertension Diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension
DESIGN NARRATIVE
In the first phase of the trial participants were randomized to a Monitored Control Group or to an Intervention Group receiving individualized intervention to achieve changes in diet and physical activity The goals of the Intervention Group were a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight a reduction in daily sodium intake to 1800 mg a modification of alcohol intake to no more than two drinks per day and an increase in regular moderate physical activity The primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the Intervention Group versus the Monitored Group In the second phase of the trial all randomized participants were followed for a minimum of five years The primary endpoints in the second phase were the incidence of high blood pressure andor hypertension
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 |
|---|---|---|---|
| R01HL021823 | NIH | None | httpsreporternihgovquickSearchR01HL021823 |