Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Atherosclerosis
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005264
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005264
Brief Title
Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)
Study Type
Observational
2. Study Status
Record Verification Date
October 2002
Overall Recruitment Status
Completed
Study Start Date
September 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Atherosclerosis
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Darwin LaBarthe
Organizational Affiliation
University of Texas
12. IPD Sharing Statement
Citations:
PubMed Identifier
7698726
Citation
Tanner JM, Oshman D, Lindgren G, Grunbaum JA, Elsouki R, Labarthe D. Reliability and validity of computer-assisted estimates of Tanner-Whitehouse skeletal maturity (CASAS): comparison with the manual method. Horm Res. 1994;42(6):288-94. doi: 10.1159/000184211.
Results Reference
background
PubMed Identifier
9193432
Citation
Labarthe DR, Nichaman MZ, Harrist RB, Grunbaum JA, Dai S. Development of cardiovascular risk factors from ages 8 to 18 in Project HeartBeat! Study design and patterns of change in plasma total cholesterol concentration. Circulation. 1997 Jun 17;95(12):2636-42. doi: 10.1161/01.cir.95.12.2636.
Results Reference
background
PubMed Identifier
9086310
Citation
Grunbaum JA, Labarthe DR, Ayars C, Harrist R, Nichaman MZ. Recruitment and enrollment for Project HeartBeat! Achieving the goals of minority inclusion. Ethn Dis. 1996 Autumn;6(3-4):203-12.
Results Reference
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PubMed Identifier
10454447
Citation
Dai S, Ayres NA, Harrist RB, Bricker JT, Labarthe DR. Validity of echocardiographic measurement in an epidemiological study. Project HeartBeat! Hypertension. 1999 Aug;34(2):236-41. doi: 10.1161/01.hyp.34.2.236.
Results Reference
background
PubMed Identifier
10094101
Citation
Fulton JE, Dai S, Grunbaum JA, Boerwinkle E, Labarthe DR. Apolipoprotein E affects serial changes in total and low-density lipoprotein cholesterol in adolescent girls: Project HeartBeat! Metabolism. 1999 Mar;48(3):285-90. doi: 10.1016/s0026-0495(99)90073-2.
Results Reference
background
PubMed Identifier
9255189
Citation
Tanner J, Oshman D, Bahhage F, Healy M. Tanner-Whitehouse bone age reference values for North American children. J Pediatr. 1997 Jul;131(1 Pt 1):34-40. doi: 10.1016/s0022-3476(97)90000-7. Erratum In: J Pediatr. 2012 Dec;161(6):1180.
Results Reference
background
PubMed Identifier
12370160
Citation
Dai S, Labarthe DR, Grunbaum JA, Harrist RB, Mueller WH. Longitudinal analysis of changes in indices of obesity from age 8 years to age 18 years. Project HeartBeat! Am J Epidemiol. 2002 Oct 15;156(8):720-9. doi: 10.1093/aje/kwf109.
Results Reference
background
PubMed Identifier
11533935
Citation
Mueller WH, Harrist RB, Doyle SR, Ayars CL, Labarthe DR. Body measurement variability, fatness, and fat-free mass in children 8, 11, and 14 years of age: Project HeartBeat! Am J Hum Biol. 1999;11(1):69-78. doi: 10.1002/(SICI)1520-6300(1999)11:13.0.CO;2-T.
Results Reference
background
PubMed Identifier
11400224
Citation
Mueller WH, Grunbaum JA, Labarthe DR. Anger expression, body fat, and blood pressure in adolescents: Project HeartBeat! Am J Hum Biol. 2001 Jul-Aug;13(4):531-8. doi: 10.1002/ajhb.1085.
Results Reference
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Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)
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