Evaluation of Childhood Blood Pressure and Lipid Screening

February 17, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1992

Primary Completion

December 7, 2022

Study Completion (Actual)

March 1, 1997

Study Registration Dates

First Submitted

May 25, 2000

First Submitted That Met QC Criteria

May 25, 2000

First Posted (Estimate)

May 26, 2000

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

May 1, 2000

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4367
  • R29HL048236 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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