Viewing Study NCT00005478



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00005478
Status: COMPLETED
Last Update Posted: 2016-05-13
First Post: 2000-05-25

Brief Title: Precursors of CVD 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: 2004-03
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 elucidate the changes in body size composition and configuration occurring in adolescence because these are important precursors of change in blood pressure and blood lipids
Detailed Description: BACKGROUND

Project HeartBeat was uniquely designed to investigate the course of change in cardiovascular disease risk factors and several categories of covariates including the anthropometric indicators addressed in this study The data pertained to the 678 participants who entered the Project in 1991-93 at ages 8 11 or 14 years of age of whom 491 percent were female and 201 percent were black Of the 395 participants who became eligible for 10 or more 4-monthly examinations 349 884 percent completed at least 10 occasions 538 participants of 556 who were eligible for seven or more examinations 968 percent completed at least seven Multi-level MLn analytic methods previously tested with other data were utilized for this analysis

DESIGN NARRATIVE

Data from Project Heartbeat were analyzed Hypotheses tested included 1 the time patterns of change in several indicators of body size composition and configuration over the period of observation 2 the relations between the time patterns of change in these indicators and the corresponding patterns for change in selected endocrine factors and 3 the explanatory contributions of energy intake and expenditure to variation between individuals in their observed time patterns of change in these indicators The anthropometric indicators addressed were weight total mass height body mass index BMI wtht2 fat-free mass fat mass per cent body fat and fat distribution waisthip ratio Each of these indicators were examined first separately and then in relation to selected endocrinologic measures testosterone estradiol and DHEAS and to energy intake and expenditure from interview histories of diet and physical activity Existing data from up to twelve 4-monthly examinations over the age range from 8-17 years conducted in Project HeartBeat were analyzed

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
R03HL057101 NIH None httpsreporternihgovquickSearchR03HL057101