NCT00223600

Brief Summary

1062 children at the age of 7 months and their families were randomized 1:1 in an intervention arm and a control arm. The intervention families has received child-oriented and individualized nutritional and life-style counseling that aims at decreasing child's exposure to the known environmental atherosclerosis risk factors. The controls children receive information as given at the well-baby clinics and in school health care of children and adolescents. The hypothesis is that the intervention children have healthier food habits and serum serum lipid and lipoprotein concentrations than the controls, fewer of them start smoking, and their physical activity level is higher than that of the controls.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,062

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 1990

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 1990

Completed
15.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 19, 2006

Status Verified

August 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 18, 2006

Conditions

Atherosclerosis

Keywords

lipidslipoproproteinsgrowthneurological developmentvascular wallblood pressurenutrient intake

Outcome Measures

Primary Outcomes (6)

  • Intake of nutrients

  • Serum lipid and lipoprotein concentrations

  • Growth and development

  • Smoking

  • Physical activity level and fitness

  • Intima-media thickness of arteries and rate of NO-induced vasodilatation

Secondary Outcomes (1)

  • Psychological burden caused by the intervention

Interventions

Nutritional and life style counselingBEHAVIORAL

Eligibility Criteria

Age7 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children at the age of 7 months and their families, recruited from the general population

You may not qualify if:

  • severe sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, University of Turku

Turku, FI-20520, Finland

Location

Related Publications (33)

  • Angle S, Keskinen S, Lapinleimu H, Helenius H, Raittinen P, Ronnemaa T, Simell O. Weight gain since infancy and prepubertal body dissatisfaction. Arch Pediatr Adolesc Med. 2005 Jun;159(6):567-71. doi: 10.1001/archpedi.159.6.567.

    PMID: 15939857BACKGROUND

  • Viikari JS, Niinikoski H, Juonala M, Raitakari OT, Lagstrom H, Kaitosaari T, Ronnemaa T, Simell O. Risk factors for coronary heart disease in children and young adults. Acta Paediatr Suppl. 2004 Dec;93(446):34-42. doi: 10.1111/j.1651-2227.2004.tb00237.x.

    PMID: 15702668BACKGROUND

  • Volanen I, Raitakari OT, Vainionpaa R, Arffman M, Aarnisalo J, Angle S, Kallio K, Simell O. Serum lipid profiles poorly correlate with Chlamydia pneumoniae, Helicobacter pylori, and cytomegalovirus seropositivity in prospectively followed-up healthy children. Arterioscler Thromb Vasc Biol. 2005 Apr;25(4):827-32. doi: 10.1161/01.ATV.0000158382.50942.6a. Epub 2005 Feb 3.

    PMID: 15692096BACKGROUND

  • Hakanen M, Ronnemaa T, Talvia S, Rask-Nissila L, Koulu M, Viikari J, Bergendahl M, Simell O. Serum leptin concentration poorly reflects growth and energy and nutrient intake in young children. Pediatrics. 2004 May;113(5):1273-8. doi: 10.1542/peds.113.5.1273.

    PMID: 15121941BACKGROUND

  • Ruottinen S, Karjalainen S, Pienihakkinen K, Lagstrom H, Niinikoski H, Salminen M, Ronnemaa T, Simell O. Sucrose intake since infancy and dental health in 10-year-old children. Caries Res. 2004 Mar-Apr;38(2):142-8. doi: 10.1159/000075938.

    PMID: 14767171BACKGROUND

  • Heiskanen MA, Aatsinki A, Hakonen P, Kartiosuo N, Munukka E, Lahti L, Keskitalo A, Huovinen P, Niinikoski H, Viikari J, Ronnemaa T, Lagstrom H, Jula A, Raitakari O, Rovio SP, Pahkala K. Association of Long-Term Habitual Dietary Fiber Intake since Infancy with Gut Microbiota Composition in Young Adulthood. J Nutr. 2024 Feb;154(2):744-754. doi: 10.1016/j.tjnut.2024.01.008. Epub 2024 Jan 12.

    PMID: 38219864DERIVED

  • Laitinen TT, Saha E, Pahkala K, Kartiosuo N, Nuotio J, Lagstrom H, Viikari J, Ronnemaa T, Jula A, Raitakari O, Niinikoski H. Associations of breastfeeding duration with serum lipid values from infancy until age 20 years - the STRIP study. Scand J Public Health. 2024 Aug;52(6):685-691. doi: 10.1177/14034948231183030. Epub 2023 Jun 30.

    PMID: 37387272DERIVED

  • Laitinen TT, Nuotio J, Niinikoski H, Juonala M, Rovio SP, Viikari JSA, Ronnemaa T, Magnussen CG, Sabin M, Burgner D, Jokinen E, Lagstrom H, Jula A, Simell O, Raitakari OT, Pahkala K. Attainment of Targets of the 20-Year Infancy-Onset Dietary Intervention and Blood Pressure Across Childhood and Young Adulthood: The Special Turku Coronary Risk Factor Intervention Project (STRIP). Hypertension. 2020 Nov;76(5):1572-1579. doi: 10.1161/HYPERTENSIONAHA.120.15075. Epub 2020 Sep 14.

    PMID: 32921196DERIVED

  • Laitinen TT, Nuotio J, Rovio SP, Niinikoski H, Juonala M, Magnussen CG, Jokinen E, Lagstrom H, Jula A, Viikari JSA, Ronnemaa T, Simell O, Raitakari OT, Pahkala K. Dietary Fats and Atherosclerosis From Childhood to Adulthood. Pediatrics. 2020 Apr;145(4):e20192786. doi: 10.1542/peds.2019-2786. Epub 2020 Mar 24.

    PMID: 32209700DERIVED

  • Laitinen TT, Nuotio J, Juonala M, Niinikoski H, Rovio S, Viikari JSA, Ronnemaa T, Magnussen CG, Jokinen E, Lagstrom H, Jula A, Simell O, Raitakari OT, Pahkala K. Success in Achieving the Targets of the 20-Year Infancy-Onset Dietary Intervention: Association With Insulin Sensitivity and Serum Lipids. Diabetes Care. 2018 Oct;41(10):2236-2244. doi: 10.2337/dc18-0869. Epub 2018 Aug 2.

    PMID: 30072407DERIVED

  • Lehtovirta M, Pahkala K, Niinikoski H, Kangas AJ, Soininen P, Lagstrom H, Viikari JSA, Ronnemaa T, Jula A, Ala-Korpela M, Wurtz P, Raitakari OT. Effect of Dietary Counseling on a Comprehensive Metabolic Profile from Childhood to Adulthood. J Pediatr. 2018 Apr;195:190-198.e3. doi: 10.1016/j.jpeds.2017.11.057. Epub 2018 Feb 1.

    PMID: 29397160DERIVED

  • Jaakkola JM, Pahkala K, Ronnemaa T, Viikari J, Niinikoski H, Jokinen E, Lagstrom H, Jula A, Raitakari O. Longitudinal child-oriented dietary intervention: Association with parental diet and cardio-metabolic risk factors. The Special Turku Coronary Risk Factor Intervention Project. Eur J Prev Cardiol. 2017 Nov;24(16):1779-1787. doi: 10.1177/2047487317720286. Epub 2017 Jul 20.

    PMID: 28727955DERIVED

  • Mikola H, Pahkala K, Niinikoski H, Ronnemaa T, Viikari JSA, Jula A, Juonala M, Raitakari OT. Cardiometabolic Determinants of Carotid and Aortic Distensibility From Childhood to Early Adulthood. Hypertension. 2017 Aug;70(2):452-460. doi: 10.1161/HYPERTENSIONAHA.117.09027. Epub 2017 Jun 26.

    PMID: 28652463DERIVED

  • Jaasaari P, Tolvanen M, Niinikoski H, Karjalainen S. Advanced dental maturity of Finnish 6- to 12-yr-old children is associated with high energy intake. Eur J Oral Sci. 2016 Oct;124(5):465-471. doi: 10.1111/eos.12292. Epub 2016 Sep 20.

    PMID: 27644174DERIVED

  • Jaakkola JM, Pahkala K, Viitala M, Ronnemaa T, Viikari J, Niinikoski H, Lagstrom H, Jula A, Simell O, Raitakari O. Association of Adiponectin with Adolescent Cardiovascular Health in a Dietary Intervention Study. J Pediatr. 2015 Aug;167(2):353-60.e1. doi: 10.1016/j.jpeds.2015.04.044. Epub 2015 May 15.

    PMID: 25982143DERIVED

  • Lapinleimu J, Raitakari OT, Lapinleimu H, Pahkala K, Ronnemaa T, Simell OG, Viikari JS. High lipoprotein(a) concentrations are associated with impaired endothelial function in children. J Pediatr. 2015 Apr;166(4):947-52.e1-2. doi: 10.1016/j.jpeds.2014.12.051. Epub 2015 Feb 4.

    PMID: 25661407DERIVED

  • Nupponen M, Pahkala K, Juonala M, Magnussen CG, Niinikoski H, Ronnemaa T, Viikari JS, Saarinen M, Lagstrom H, Jula A, Simell O, Raitakari OT. Metabolic syndrome from adolescence to early adulthood: effect of infancy-onset dietary counseling of low saturated fat: the Special Turku Coronary Risk Factor Intervention Project (STRIP). Circulation. 2015 Feb 17;131(7):605-13. doi: 10.1161/CIRCULATIONAHA.114.010532. Epub 2015 Jan 20.

    PMID: 25605660DERIVED

  • Ahola-Olli AV, Pitkanen N, Kettunen J, Oikonen MK, Mikkila V, Lehtimaki T, Kahonen M, Pahkala K, Niinikoski H, Kangas AJ, Soininen P, Ala-Korpela M, Viikari JS, Ronnemaa T, Simell O, Raitakari OT. Interactions between genetic variants and dietary lipid composition: effects on circulating LDL cholesterol in children. Am J Clin Nutr. 2014 Dec;100(6):1569-77. doi: 10.3945/ajcn.114.085027. Epub 2014 Oct 8.

    PMID: 25411292DERIVED

  • Mikola H, Pahkala K, Ronnemaa T, Viikari JS, Niinikoski H, Jokinen E, Salo P, Simell O, Juonala M, Raitakari OT. Distensibility of the aorta and carotid artery and left ventricular mass from childhood to early adulthood. Hypertension. 2015 Jan;65(1):146-52. doi: 10.1161/HYPERTENSIONAHA.114.03316. Epub 2014 Oct 27.

    PMID: 25350980DERIVED

  • Laine MA, Tolvanen M, Pienihakkinen K, Soderling E, Niinikoski H, Simell O, Karjalainen S. The effect of dietary intervention on paraffin-stimulated saliva and dental health of children participating in a randomized controlled trial. Arch Oral Biol. 2014 Feb;59(2):217-25. doi: 10.1016/j.archoralbio.2013.11.013. Epub 2013 Dec 1.

    PMID: 24370194DERIVED

  • Oranta O, Pahkala K, Ruottinen S, Niinikoski H, Lagstrom H, Viikari JS, Jula A, Loo BM, Simell O, Ronnemaa T, Raitakari OT. Infancy-onset dietary counseling of low-saturated-fat diet improves insulin sensitivity in healthy adolescents 15-20 years of age: the Special Turku Coronary Risk Factor Intervention Project (STRIP) study. Diabetes Care. 2013 Oct;36(10):2952-9. doi: 10.2337/dc13-0361. Epub 2013 Jun 25.

    PMID: 23801725DERIVED

  • Pahkala K, Laitinen TT, Heinonen OJ, Viikari JS, Ronnemaa T, Niinikoski H, Helajarvi H, Juonala M, Simell O, Raitakari OT. Association of fitness with vascular intima-media thickness and elasticity in adolescence. Pediatrics. 2013 Jul;132(1):e77-84. doi: 10.1542/peds.2013-0041. Epub 2013 Jun 10.

    PMID: 23753102DERIVED

  • Pahkala K, Hietalampi H, Laitinen TT, Viikari JS, Ronnemaa T, Niinikoski H, Lagstrom H, Talvia S, Jula A, Heinonen OJ, Juonala M, Simell O, Raitakari OT. Ideal cardiovascular health in adolescence: effect of lifestyle intervention and association with vascular intima-media thickness and elasticity (the Special Turku Coronary Risk Factor Intervention Project for Children [STRIP] study). Circulation. 2013 May 28;127(21):2088-96. doi: 10.1161/CIRCULATIONAHA.112.000761. Epub 2013 Apr 23.

    PMID: 23613255DERIVED

  • Niinikoski H, Ruottinen S. Is carbohydrate intake in the first years of life related to future risk of NCDs? Nutr Metab Cardiovasc Dis. 2012 Oct;22(10):770-4. doi: 10.1016/j.numecd.2012.05.002. Epub 2012 Jul 11.

    PMID: 22789807DERIVED

  • Niinikoski H, Pahkala K, Ala-Korpela M, Viikari J, Ronnemaa T, Lagstrom H, Jokinen E, Jula A, Savolainen MJ, Simell O, Raitakari OT. Effect of repeated dietary counseling on serum lipoproteins from infancy to adulthood. Pediatrics. 2012 Mar;129(3):e704-13. doi: 10.1542/peds.2011-1503. Epub 2012 Feb 13.

    PMID: 22331346DERIVED

  • Pahkala K, Heinonen OJ, Simell O, Viikari JS, Ronnemaa T, Niinikoski H, Raitakari OT. Association of physical activity with vascular endothelial function and intima-media thickness. Circulation. 2011 Nov 1;124(18):1956-63. doi: 10.1161/CIRCULATIONAHA.111.043851. Epub 2011 Oct 3.

    PMID: 21969011DERIVED

  • Karjalainen S, Soderling E, Saarinen M, Larsson B, Johansson I, Simell O, Niinikoski H. Effect of infancy-onset dietary intervention on salivary cholesterol of children: a randomized controlled trial. J Dent Res. 2011 Jul;90(7):868-73. doi: 10.1177/0022034511405328. Epub 2011 Apr 7.

    PMID: 21474838DERIVED

  • Kallio K, Jokinen E, Saarinen M, Hamalainen M, Volanen I, Kaitosaari T, Ronnemaa T, Viikari J, Raitakari OT, Simell O. Arterial intima-media thickness, endothelial function, and apolipoproteins in adolescents frequently exposed to tobacco smoke. Circ Cardiovasc Qual Outcomes. 2010 Mar;3(2):196-203. doi: 10.1161/CIRCOUTCOMES.109.857771. Epub 2010 Mar 2.

    PMID: 20197510DERIVED

  • Niinikoski H, Jula A, Viikari J, Ronnemaa T, Heino P, Lagstrom H, Jokinen E, Simell O. Blood pressure is lower in children and adolescents with a low-saturated-fat diet since infancy: the special turku coronary risk factor intervention project. Hypertension. 2009 Jun;53(6):918-24. doi: 10.1161/HYPERTENSIONAHA.109.130146. Epub 2009 Apr 13.

    PMID: 19364991DERIVED

  • Hakanen M, Raitakari OT, Lehtimaki T, Peltonen N, Pahkala K, Sillanmaki L, Lagstrom H, Viikari J, Simell O, Ronnemaa T. FTO genotype is associated with body mass index after the age of seven years but not with energy intake or leisure-time physical activity. J Clin Endocrinol Metab. 2009 Apr;94(4):1281-7. doi: 10.1210/jc.2008-1199. Epub 2009 Jan 21.

    PMID: 19158205DERIVED

  • Volanen I, Kallio K, Saarinen M, Jarvisalo MJ, Vainionpaa R, Ronnemaa T, Viikari J, Marniemi J, Simell O, Raitakari OT. Arterial intima-media thickness in 13-year-old adolescents and previous antichlamydial antimicrobial use: a retrospective follow-up study. Pediatrics. 2008 Sep;122(3):e675-81. doi: 10.1542/peds.2008-0220.

    PMID: 18762502DERIVED

  • Ruottinen S, Niinikoski H, Lagstrom H, Ronnemaa T, Hakanen M, Viikari J, Jokinen E, Simell O. High sucrose intake is associated with poor quality of diet and growth between 13 months and 9 years of age: the special Turku Coronary Risk Factor Intervention Project. Pediatrics. 2008 Jun;121(6):e1676-85. doi: 10.1542/peds.2007-1642.

    PMID: 18519471DERIVED

  • Kallio K, Jokinen E, Raitakari OT, Hamalainen M, Siltala M, Volanen I, Kaitosaari T, Viikari J, Ronnemaa T, Simell O. Tobacco smoke exposure is associated with attenuated endothelial function in 11-year-old healthy children. Circulation. 2007 Jun 26;115(25):3205-12. doi: 10.1161/CIRCULATIONAHA.106.674804. Epub 2007 Jun 4.

    PMID: 17548727DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Olli G Simell, MD, PhD

    University of Turku, Turku, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

May 1, 1990

Study Completion

August 1, 2005

Last Updated

September 19, 2006

Record last verified: 2005-08

Locations

FI(1)