Viewing Study NCT00005264



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Study NCT ID: NCT00005264
Status: COMPLETED
Last Update Posted: 2016-05-13
First Post: 2000-05-25

Brief Title: Pediatric Epidemiology of Cardiovascular Disease Risk Factors Project Heartbeat
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: 2002-10
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 conduct a longitudinal natural history study of cardiovascular disease risk factors in children Growth curves were compared for levels of blood pressure lipids cardiac structures and function and related to physical growth and maturation nutrient intake physical activity body composition puberty and smoking
Detailed Description: BACKGROUND

Both the pathologic precursors of atherosclerosis and the development of its major risk factors -- blood pressure blood lipids and cigarette smoking -- are often far advanced before age 20 or within the period from birth or conception through adolescence In 1990 there was growing interest in understanding these aspects of human biology and in devising appropriate preventive measures

In 1990 knowledge about the risk factors during childhood and adolescence was based mainly on cross-sectional surveys from which very striking and consistent patterns of change with age were inferred and from which reference values for screening and management were derived Both growth and sexual maturation influence these patterns strongly yet these risk factors had only recently been taken into account in 1990 only partially in screening recommendations for blood pressure and not at all for cholesterol

DESIGN NARRATIVE

Subjects were selected by simple random sampling Data were collected on dependent variables including blood pressure heart rate echocardiography Doppler flow blood lipids and smoking Independent variables included growth diet and nutrition electrolytes physical activity and fitness personal family and social history and bone age Most observations were recorded at four month intervals There was a six month pretest recruitment period four years of cycled measurements and data collection and six months of analysis and reporting Curves for both velocity and acceleration of growth for attained levels of blood pressure blood lipids and smoking were determined as were longitudinal relationships between individual growth curves of blood pressure echocardiographic measures physical growth sexual maturation body composition diet physical activity and social factors

Dr Labarthe has several R03 grants to analyze data from Project Heartbeat See also Study 4962

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
U01HL041166 NIH None httpsreporternihgovquickSearchU01HL041166