Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006402
Status:
COMPLETED
Last Update Posted:
2008-01-21
First Post:
2000-10-12
Brief Title:
Lifestyle Adiposity and Cardiovascular Health in Youths
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:
2008-01
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 the influences of diet and physical activity PA on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence
Detailed Description:
BACKGROUND
Adult studies have shown that adiposity especially visceral adipose tissue and cardiovascular CV fitness are key links between lifestyle factors like diet and exercise on one hand and CV disease on the other However very little is known about these links during the juvenile years when the processes leading to CV disease are at an early stage of development
The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents The Program Announcement jointly issued by the National Institute of Nursing Research and the NHLBI sought to encourage research relevant to the development andor testing of dietary interventions to improve the cardiovascular disease CVD risk profiles in children and adolescents especially those at increased risk for CVD or for development of CVD risk factors because of genetics family history socioeconomic status SES raceethnicity levels of blood cholesterol or blood pressure or other factors
DESIGN NARRATIVE
The study determines the relations of free-living diet and exercise to total body percent fat percent BF visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status SES The study also determines the relations of fatness and fitness to different CVD risk factors A total of 800 15 to 18 year olds 200 in each ethnic and gender subgroup will be recruited Diet will be assessed with seven 24-hour recalls and exercise with two seven-day recalls and heart rate monitoring Percent body fat will be measured with dual-energy x-ray absorptiometry visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test Measurements will be made of major fatness- and fitness-related CV disease risk factors eg total cholesterolHDL cholesterol ratio insulin systolic blood pressure left ventricular mass indexed to height fibrinogen Multivariate and univariate analyses will be conducted to determine relationships
Adult studies have shown that adiposity especially visceral adipose tissue and cardiovascular CV fitness are key links between lifestyle factors like diet and exercise on one hand and CV disease on the other However very little is known about these links during the juvenile years when the processes leading to CV disease are at an early stage of development
The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents The Program Announcement jointly issued by the National Institute of Nursing Research and the NHLBI sought to encourage research relevant to the development andor testing of dietary interventions to improve the cardiovascular disease CVD risk profiles in children and adolescents especially those at increased risk for CVD or for development of CVD risk factors because of genetics family history socioeconomic status SES raceethnicity levels of blood cholesterol or blood pressure or other factors
DESIGN NARRATIVE
The study determines the relations of free-living diet and exercise to total body percent fat percent BF visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status SES The study also determines the relations of fatness and fitness to different CVD risk factors A total of 800 15 to 18 year olds 200 in each ethnic and gender subgroup will be recruited Diet will be assessed with seven 24-hour recalls and exercise with two seven-day recalls and heart rate monitoring Percent body fat will be measured with dual-energy x-ray absorptiometry visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test Measurements will be made of major fatness- and fitness-related CV disease risk factors eg total cholesterolHDL cholesterol ratio insulin systolic blood pressure left ventricular mass indexed to height fibrinogen Multivariate and univariate analyses will be conducted to determine relationships
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?: