NCT00000459

Brief Summary

To assess the feasibility, acceptability, efficacy, and safety of dietary intervention in free-living children ages 8-10 with elevated low density lipoprotein cholesterol levels.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1986

Longer than P75 for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1986

Completed
12.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

May 5, 2016

Status Verified

March 1, 2005

First QC Date

October 27, 1999

Last Update Submit

May 4, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesHypercholesterolemia

Interventions

diet, fat-restrictedBEHAVIORAL

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Children, ages 8 to 10, with elevated LDL-C levels.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (21)

  • Van Horn LV, Gernhofer N, Moag-Stahlberg A, Farris R, Hartmuller G, Lasser VI, Stumbo P, Craddick S, Ballew C. Dietary assessment in children using electronic methods: telephones and tape recorders. J Am Diet Assoc. 1990 Mar;90(3):412-6.

    PMID: 2307817BACKGROUND

  • Dietary intervention study in children (DISC) with elevated low-density-lipoprotein cholesterol. Design and baseline characteristics. DISC Collaborative Research Group. Ann Epidemiol. 1993 Jul;3(4):393-402. doi: 10.1016/1047-2797(93)90067-e.

    PMID: 8275216BACKGROUND

  • van Horn LV, Stumbo P, Moag-Stahlberg A, Obarzanek E, Hartmuller VW, Farris RP, Kimm SY, Frederick M, Snetselaar L, Liu K. The Dietary Intervention Study in Children (DISC): dietary assessment methods for 8- to 10-year-olds. J Am Diet Assoc. 1993 Dec;93(12):1396-403. doi: 10.1016/0002-8223(93)92241-o.

    PMID: 8245373BACKGROUND

  • Hartmuller VW, Snetselaar L, Van Horn L, et al: Creative Approaches to Cholesterol-Lowering Used in the Dietary Intervention Study in Children (DISC). Top Clin Nutr, 10:71-78, 1994.

    BACKGROUND

  • Efficacy and safety of lowering dietary intake of fat and cholesterol in children with elevated low-density lipoprotein cholesterol. The Dietary Intervention Study in Children (DISC). The Writing Group for the DISC Collaborative Research Group. JAMA. 1995 May 10;273(18):1429-35. doi: 10.1001/jama.1995.03520420045036.

    PMID: 7723156BACKGROUND

  • Stevens VJ, Obarzanek E, Franklin FA, et al for the DISC Collaborative Research Group. Dietary Intervention Study in Children (DISC): intervention design and participation. J Nutr Educ 1995;27:133-140.

    BACKGROUND

  • Luepker RV. Reducing blood cholesterol levels in children. What have we learned from the DISC study? JAMA. 1995 May 10;273(18):1461-2. No abstract available.

    PMID: 7723162BACKGROUND

  • Simons-Morton DG, Hunsberger SA, Van Horn L, Barton BA, Robson AM, McMahon RP, Muhonen LE, Kwiterovich PO, Lasser NL, Kimm SY, Greenlick MR. Nutrient intake and blood pressure in the Dietary Intervention Study in Children. Hypertension. 1997 Apr;29(4):930-6. doi: 10.1161/01.hyp.29.4.930.

    PMID: 9095079BACKGROUND

  • Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VV, Barton BA, Stevens VJ, Kwiterovich PO, Franklin FA, Kimm SY, Lasser NL, Simons-Morton DG, Lauer RM. Safety of a fat-reduced diet: the Dietary Intervention Study in Children (DISC). Pediatrics. 1997 Jul;100(1):51-9. doi: 10.1542/peds.100.1.51.

    PMID: 9200359BACKGROUND

  • Kwiterovich PO Jr, Barton BA, McMahon RP, Obarzanek E, Hunsberger S, Simons-Morton D, Kimm SY, Friedman LA, Lasser N, Robson A, Lauer R, Stevens V, Van Horn L, Gidding S, Snetselaar L, Hartmuller VW, Greenlick M, Franklin F Jr. Effects of diet and sexual maturation on low-density lipoprotein cholesterol during puberty: the Dietary Intervention Study in Children (DISC). Circulation. 1997 Oct 21;96(8):2526-33. doi: 10.1161/01.cir.96.8.2526.

    PMID: 9355889BACKGROUND

  • Reimers TM, Brown KM, Van Horn L, Stevens V, Obarzanek E, Hartmuller VW, Snetselaar L, von Almen TK, Chiostri J. Maternal acceptability of a dietary intervention designed to lower children's intake of saturated fat and cholesterol: the Dietary Intervention Study in Children (DISC). J Am Diet Assoc. 1998 Jan;98(1):31-4. doi: 10.1016/s0002-8223(98)00010-8.

    PMID: 9434647BACKGROUND

  • Berg-Smith SM, Stevens VJ, Brown KM, Van Horn L, Gernhofer N, Peters E, Greenberg R, Snetselaar L, Ahrens L, Smith K. A brief motivational intervention to improve dietary adherence in adolescents. The Dietary Intervention Study in Children (DISC) Research Group. Health Educ Res. 1999 Jun;14(3):399-410. doi: 10.1093/her/14.3.399.

    PMID: 10539230BACKGROUND

  • Obarzanek E, Kimm SY, Barton BA, Van Horn L L, Kwiterovich PO Jr, Simons-Morton DG, Hunsberger SA, Lasser NL, Robson AM, Franklin FA Jr, Lauer RM, Stevens VJ, Friedman LA, Dorgan JF, Greenlick MR; DISC Collaborative Research Group. Long-term safety and efficacy of a cholesterol-lowering diet in children with elevated low-density lipoprotein cholesterol: seven-year results of the Dietary Intervention Study in Children (DISC). Pediatrics. 2001 Feb;107(2):256-64. doi: 10.1542/peds.107.2.256.

    PMID: 11158455BACKGROUND

  • Lauer RM, Obarzanek E, Hunsberger SA, Van Horn L, Hartmuller VW, Barton BA, Stevens VJ, Kwiterovich PO Jr, Franklin FA Jr, Kimm SY, Lasser NL, Simons-Morton DG. Efficacy and safety of lowering dietary intake of total fat, saturated fat, and cholesterol in children with elevated LDL cholesterol: the Dietary Intervention Study in Children. Am J Clin Nutr. 2000 Nov;72(5 Suppl):1332S-1342S. doi: 10.1093/ajcn/72.5.1332s.

    PMID: 11063475BACKGROUND

  • Lavigne JV, Brown KM, Gidding S, Evans M, Stevens VJ, von Almen TK, Ewart C, Weil C. A cholesterol-lowering diet does not produce adverse psychological effects in children: three-year results from the dietary intervention study in children. Health Psychol. 1999 Nov;18(6):604-13. doi: 10.1037//0278-6133.18.6.604.

    PMID: 10619534BACKGROUND

  • Jung S, Goloubeva O, Hylton N, Klifa C, LeBlanc E, Shepherd J, Snetselaar L, Van Horn L, Dorgan JF. Intake of dietary carbohydrates in early adulthood and adolescence and breast density among young women. Cancer Causes Control. 2018 Jul;29(7):631-642. doi: 10.1007/s10552-018-1040-1. Epub 2018 May 25.

    PMID: 29802491DERIVED

  • Bertrand KA, Baer HJ, Orav EJ, Klifa C, Kumar A, Hylton NM, LeBlanc ES, Snetselaar LG, Van Horn L, Dorgan JF. Early Life Body Fatness, Serum Anti-Mullerian Hormone, and Breast Density in Young Adult Women. Cancer Epidemiol Biomarkers Prev. 2016 Jul;25(7):1151-7. doi: 10.1158/1055-9965.EPI-16-0185. Epub 2016 May 9.

    PMID: 27197299DERIVED

  • Jung S, Egleston BL, Chandler DW, Van Horn L, Hylton NM, Klifa CC, Lasser NL, LeBlanc ES, Paris K, Shepherd JA, Snetselaar LG, Stanczyk FZ, Stevens VJ, Dorgan JF. Adolescent endogenous sex hormones and breast density in early adulthood. Breast Cancer Res. 2015 Jun 4;17(1):77. doi: 10.1186/s13058-015-0581-4.

    PMID: 26041651DERIVED

  • Uchino R, Isayama H, Tsujino T, Sasahira N, Ito Y, Matsubara S, Takahara N, Arizumi T, Toda N, Mohri D, Togawa O, Yagioka H, Yanagihara Y, Nakajima K, Akiyama D, Hamada T, Miyabayashi K, Mizuno S, Kawakubo K, Kogure H, Sasaki T, Yamamoto N, Nakai Y, Hirano K, Tada M, Koike K. Results of the Tokyo trial of prevention of post-ERCP pancreatitis with risperidone-2: a multicenter, randomized, placebo-controlled, double-blind clinical trial. Gastrointest Endosc. 2013 Dec;78(6):842-850. doi: 10.1016/j.gie.2013.06.028. Epub 2013 Jul 30.

    PMID: 23910063DERIVED

  • Dorgan JF, Liu L, Barton BA, Deshmukh S, Snetselaar LG, Van Horn L, Stevens VJ, Robson AM, Lasser NL, Himes JH, Shepherd JA, Pourfarzib R, Pettee Gabriel K, Kriska A, Kwiterovich PO Jr. Adolescent diet and metabolic syndrome in young women: results of the Dietary Intervention Study in Children (DISC) follow-up study. J Clin Endocrinol Metab. 2011 Dec;96(12):E1999-2008. doi: 10.1210/jc.2010-2726. Epub 2011 Oct 12.

    PMID: 21994964DERIVED

  • Kerver JM, Gardiner JC, Dorgan JF, Rosen CJ, Velie EM. Dietary predictors of the insulin-like growth factor system in adolescent females: results from the Dietary Intervention Study in Children (DISC). Am J Clin Nutr. 2010 Mar;91(3):643-50. doi: 10.3945/ajcn.2009.28205. Epub 2010 Jan 20.

    PMID: 20089725DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHypercholesterolemia

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Bruce Barton

    Maryland Medical Research Institute

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

December 1, 1986

Study Completion

January 1, 1999

Last Updated

May 5, 2016

Record last verified: 2005-03