Evaluation of Cholesterol Education for At-Risk Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005718
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 18, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To evaluate two educational programs that promoted the role of pediatric practices in lowering LDL cholesterol levels in 4-10 year old hypercholesterolemic children through dietary modification.

Condition or disease
Cardiovascular Diseases Heart Diseases Hypercholesterolemia Coronary Heart Disease Risk Reduction

Detailed Description:


Outcomes of the study provided valuable guidance for pediatricians who wanted to become more actively involved in identifying and treating children with elevated blood lipids.


Pediatricians in five practices in Abington, Pennsylvania conducted a cholesterol screening program (capillary bloodsample) for 4-10 year old children in their care. Children who tested positive (total cholesterol >176 mg/dl) were offered follow-up evaluations (two fasting venous blood samples) to confirm the positive initial test. Those with mean LDL cholesterol levels between the 80th and 98th percentiles for age/sex (107-164 mg/dl for boys and 112-164 mg/dl for girls) and who met other entry criteria were invited to join the study. Children with parental permission to participate were randomized to one of three groups: two that received dietary education, and a comparison group that received no dietary education. One educational program used face-to-face counseling with a registered dietitian and the other used a home-based, parent-child autotutorial approach. In addition, a random sample of non-hypercholesterolemic children with total plasma cholesterol levels between the 40th and 60th percentiles for age/sex were invited to join the study as a second comparison group. Prior to the education period (baseline) and three times thereafter (3, 6 and 12 months post-baseline), all four groups were assessed for consumption of total fat, saturated fat, and cholesterol, and their growth and pertinent cognitive psychosocial factors. Also, the plasma LDL cholesterol levels of the three hypercholesterolemic groups were assessed at all four time points along with blood indicators of iron status at baseline and twelve months.

To assess the educational programs' effectiveness, changes were compared in assessed variables of the hypercholesterolemic groups who did and did not receive dietary education. Also, changes in diet, growth, and cognitive/psychosocial factors in these groups were compared with those of the non-hypercholesterolemic group that had neither a positive diagnosis of elevated blood lipids nor dietary education. Additionally, the cost-effectiveness of the two dietary education programs was evaluated.

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 Type : Observational
Study Start Date : April 1990
Actual Study Completion Date : March 1993

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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

Publications: Identifier: NCT00005718     History of Changes
Other Study ID Numbers: 4927
R01HL043880 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: February 18, 2016
Last Verified: July 2000

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases