Dietary Intervention Study in Children (DISC) - Catalog

Name

Dietary Intervention Study in Children (DISC)

Accession Number

HLB00400524a

Acronym

DISC

Related studies

(DISC06) Dietary Intervention Study in Children Follow-Up Study (DISC06)

BSI Study IDs

DIS

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Pediatric

Interventions

Behavioral: diet, fat-restricted

Study Open Date (Data)

2009-10-01

Study Open Date (Specimens)

2012-08-31

Date materials available

2008-10-13

Last updated

2005-06-23

Study period

1986-1999

Study Contacts
NHLBI Division

DCVS

Classification

Heart

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

1620

# of Returned Specimens

0

Conditions

Cardiovascular Diseases
Heart Diseases
Hypercholesterolemia

Objectives

The Dietary Intervention Study in Children (DISC) trial was initiated in 1987 and sought to evaluate the efficacy and safety of a lipid lowering diet in 8 to 10 year old children after at least 3 years of followup. The primary efficacy outcome was low-density lipoprotein (LDL) cholesterol. Secondary efficacy outcomes were total cholesterol, high-density lipoprotein (HDL), cholesterol, and triglycerides. Primary safety outcomes were height and serum ferritin. Secondary safety outcomes included serum zinc, folate, retinol, and albumin. The trial was extended, with continuation of the intervention, albeit at a diminished intensity, to follow the children for an additional 4 years, resulting in a mean of 7.4 years of total follow-up, when the participants were on average 17 years old.

Background

A growing body of evidence suggests that atherosclerosis is a long term process that may begin early in childhood. Autopsy studies have revealed coronary fatty streaks in obese children, and other studies have shown that blood cholesterol levels show a fairly high correlation as children age into young adults. Familial clustering of lipid levels provide further rationale for intervention studies aimed at reducing cholesterol levels in children. Previous studies have demonstrated the efficacy of dietary interventions in adults in reducing blood cholesterol levels; however, the safety and efficacy of dietary interventions in growing children were less clear, and previous studies were only short-term interventions.

Subjects

The DISC study was a multicenter, randomized controlled trial that enrolled 663 prepubertal children aged 8 to 10 years who had elevated LDL-cholesterol levels (80th-98th percentile based on age-gender distributions from the Lipid Research Clinics). The children were assigned at random to an intervention or usual care group. Fifty-five percent of the participants were male. The intervention group attended a series of group and individual sessions where the children and their families were counseled to follow a diet containing 28 percent of calories as total fat, less than 8 percent of calories from saturated fat, dietary cholesterol intake less than 75 mg/1000 kcal, and up to 9% of calories from polyunsaturated fat. The diets were designed to meet nutritional requirements of growing children. The usual care group was provided a packet of educational publications on heart-healthy eating that were generally available to the public. The primary endpoint was change in LDL-cholesterol after three years of followup, and subsequently after 7 years of follow-up.

Design

Conclusions

After three years of followup, LDL cholesterol decreased by an average of 15.4 mg/dL in the intervention group and 11.9 mg/dL in the usual care group. This difference of 3.3 mg/dL (adjusted for baseline levels and gender) was significant (p=0.02). There were no significant differences between the two groups in adjusted mean height or serum ferritin. There were no significant differences in secondary safety measures as well. (JAMA, 1995; 273(18):1429-35). After 7 years of followup, the difference in LDL-cholesterol between the two treatment groups decreased to 2.0 mg/dL, which was no longer significant. There continued to be no significant differences in an adverse direction in primary or secondary safety measures. (Pediatrics, 2001;107(2):256-264).

Disease classification

Publications

Mat types

Serum

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    Intervention: 334

    Usual care: 329


    Last Modified: July 28, 2014, 4:10 p.m.
  • Age

     

    Intervention

    Usual Care

    All

    N

    %

    N

    %

    N

    %

    8

    81

    24.25

    79

    24.01

    160

    24.13

    9

    169

    50.60

    163

    49.54

    332

    50.08

    10

    84

    25.15

    87

    26.44

    171

    25.79

     

    Last Modified: Aug. 24, 2015, 2:26 p.m.
  • Sex
     

     

    Intervention

    Usual Care

    All

    N

    %

    N

    %

    N

    %

    Male

    179

    53.59

    183

    55.62

    362

    54.60

    Female

    155

    46.41

    146

    44.38

    301

    45.40

     

    Last Modified: Aug. 24, 2015, 2:26 p.m.
  • Race

     

    Intervention

    Usual Care

    All

    N

    %

    N

    %

    N

    %

    White

    289

    86.53

    285

    86.63

    574

    86.58

    Black

    25

    7.49

    31

    9.42

    56

    8.45

    Other

    20

    5.99

    13

    3.95

    33

    4.98


    Last Modified: Aug. 24, 2015, 2:26 p.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3 of the BioLINCC handbook describes the components of the review process

  • Material Types
  • General Freeze/Thaw Status
  • Visits (Vials)

    10/22/2019

      Serum Total
    Screening Visit 1 976 976
    Screening Visit 2 1,756 1,756
    Baseline 9 9
    Intervention Visit 254 254
    Month 6 276 276
    Month 12 1,417 1,417
    Month 27 1 1
    Month 36 3,602 3,602
    Month 37 1,779 1,779
    Month 48 542 542
    Year 5 1,858 1,858
    Year 6 4 4
    Year 7 1,128 1,128
    Final Visit 1 3,263 3,263
    Final Visit 2 (Repeat) 91 91
    Unknown 3 3

    Last Modified: Oct. 22, 2019, 3 p.m.
  • Visits (Subjects)

    10/22/2019

      Serum
    Total number of subjects Average volume (ml) per subject
    Screening Visit 1 408 1.42
    Screening Visit 2 638 1.53
    Baseline 7 8.14
    Intervention Visit 83 6.08
    Month 6 105 1.19
    Month 12 507 1.33
    Month 27 1 2.00
    Month 36 599 6.77
    Month 37 472 2.22
    Month 48 87 3.74
    Year 5 446 2.53
    Year 6 1 6.10
    Year 7 229 3.40
    Final Visit 1 554 3.91
    Final Visit 2 (Repeat) 45 1.08
    Unknown 1 3.00

    Last Modified: Oct. 22, 2019, 3 p.m.