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NCT00005439 Clinical Trial

Evaluation of Childhood Blood Pressure and Lipid Screening

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005439
Other study ID # 4367
Secondary ID R29HL048236
Status Completed
Phase N/A
First received May 25, 2000
Last updated February 17, 2016
Start date April 1992
Est. completion date March 1997

Study information
Verified date May 2000
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 help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.

Description:

BACKGROUND:

To be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. Screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. Long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. However, information was sparse regarding reliability of measurements, accounting for which could improve validity. The efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. In addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. The results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults.

DESIGN NARRATIVE:

The study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of BP and lipid measurements (i.e., the reliability of the test) and its impact on tracking of BP and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood BP and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for BP control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date March 1997
Est. primary completion date
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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Cook NR, Gillman MW, Rosner BA, Taylor JO, Hennekens CH. Prediction of young adult blood pressure from childhood blood pressure, height, and weight. J Clin Epidemiol. 1997 May;50(5):571-9. — View Citation

Gillman MW, Cook NR, Evans DA, Rosner B, Hennekens CH. Relationship of alcohol intake with blood pressure in young adults. Hypertension. 1995 May;25(5):1106-10. — View Citation

Gillman MW, Cook NR. Blood pressure measurement in childhood epidemiological studies. Circulation. 1995 Aug 15;92(4):1049-57. Review. — View Citation

Gillman MW, Cupples LA, Gagnon D, Millen BE, Ellison RC, Castelli WP. Margarine intake and subsequent coronary heart disease in men. Epidemiology. 1997 Mar;8(2):144-9. — View Citation

Gillman MW, Cupples LA, Gagnon D, Posner BM, Ellison RC, Castelli WP, Wolf PA. Protective effect of fruits and vegetables on development of stroke in men. JAMA. 1995 Apr 12;273(14):1113-7. — View Citation

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