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Evaluation of Cholesterol Education for At-Risk Children

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005718
    Brief Title
    Evaluation of Cholesterol Education for At-Risk Children
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    July 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1990 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 1993 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Coronary Heart Disease Risk Reduction

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    1488965
    Citation
    Derr JA, Mitchell DC, Brannon D, Smiciklas-Wright H, Dixon LB, Shannon BM. Time and cost analysis of a computer-assisted telephone interview system to collect dietary recalls. Am J Epidemiol. 1992 Dec 1;136(11):1386-92. doi: 10.1093/oxfordjournals.aje.a116451.
    Results Reference
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    PubMed Identifier
    7971012
    Citation
    Shannon BM, Tershakovec AM, Martel JK, Achterberg CL, Cortner JA, Smiciklas-Wright HS, Stallings VA, Stolley PD. Reduction of elevated LDL-cholesterol levels of 4- to 10-year-old children through home-based dietary education. Pediatrics. 1994 Dec;94(6 Pt 1):923-7.
    Results Reference
    background
    PubMed Identifier
    8438823
    Citation
    Bennett MJ, Tershakovec AM, Cortner JA, Shannon BM. A quality assurance program for the measurement of capillary blood cholesterol levels in private pediatric practices. The Children's Health Project. Am J Dis Child. 1993 Mar;147(3):340-5. doi: 10.1001/archpedi.1993.02160270102031.
    Results Reference
    background
    PubMed Identifier
    9544893
    Citation
    Tershakovec AM, Jawad AF, Stallings VA, Cortner JA, Zemel BS, Shannon BM. Age-related changes in cardiovascular disease risk factors of hypercholesterolemic children. J Pediatr. 1998 Mar;132(3 Pt 1):414-20. doi: 10.1016/s0022-3476(98)70012-5.
    Results Reference
    background
    PubMed Identifier
    9356540
    Citation
    Dixon LB, Shannon BM, Tershakovec AM, Bennett MJ, Coates PM, Cortner JA. Effects of family history of heart disease, apolipoprotein E phenotype, and lipoprotein(a) on the response of children's plasma lipids to change in dietary lipids. Am J Clin Nutr. 1997 Nov;66(5):1207-17. doi: 10.1093/ajcn/66.5.1207.
    Results Reference
    background
    PubMed Identifier
    9346988
    Citation
    Dixon LB, McKenzie J, Shannon BM, Mitchell DC, Smiciklas-Wright H, Tershakovec AM. The effect of changes in dietary fat on the food group and nutrient intake of 4- to 10-year-old children. Pediatrics. 1997 Nov;100(5):863-72. doi: 10.1542/peds.100.5.863.
    Results Reference
    background
    PubMed Identifier
    8784330
    Citation
    McKenzie J, Dixon LB, Smiciklas-Wright H, Mitchell D, Shannon B, Tershakovec A. Change in nutrient intakes, number of servings, and contributions of total fat from food groups in 4- to 10-year-old children enrolled in a nutrition education study. J Am Diet Assoc. 1996 Sep;96(9):865-73. doi: 10.1016/s0002-8223(96)00238-6.
    Results Reference
    background
    PubMed Identifier
    9431285
    Citation
    Brannon SD, Tershakovec AM, Shannon BM. The cost-effectiveness of alternative methods of nutrition education for hypercholesterolemic children. Am J Public Health. 1997 Dec;87(12):1967-70. doi: 10.2105/ajph.87.12.1967.
    Results Reference
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    Evaluation of Cholesterol Education for At-Risk Children

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