Evaluation of Cholesterol Education for At-Risk Children

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005718
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: July 2000
  Purpose

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
Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia
Coronary Heart Disease Risk Reduction

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1990
Estimated Study Completion Date: March 1993
Detailed Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005718     History of Changes
Other Study ID Numbers: 4927
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 23, 2014