Pediatric Epidemiology of Cardiovascular Disease Risk Factors (Project Heartbeat)

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005264
• Other study ID #: 1148
• Secondary ID: U01HL041166
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: September 1990
• Est. completion date: September 1996

Study information

• Verified date: October 2002
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 1996
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Heart Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum in: J Pediatr. 2012 Dec;161(6):1180. — View 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. — View Citation