Clinical trial NCT00223600: Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Official title: Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atherosclerosis
Keywords: lipids
lipoproproteins
growth
neurological development
vascular wall
blood pressure
nutrient intake
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 1062
Sex: ALL
Minimum age (years): 7
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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. We further hypothesised that the life-style intervention had no adverse mental or somatic effects on the children. Intima-media thickness of the carotid and brachial arterias and aorta and vasodilatation of the brachial artery induced by endogenous NO production have been also been measures at 2-year intervals since the age of 11 years. Recruitment to the study began in 1990 and continued for 2 years. The children are now between 14 and 16 years of age. 550 children remain in the study, which will continue until the last children have reached the age of 20 years.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* severe sickness

Primary outcomes:
measure: Intake of nutrients
measure: Serum lipid and lipoprotein concentrations
measure: Growth and development
measure: Smoking
measure: Physical activity level and fitness
measure: Intima-media thickness of arteries and rate of NO-induced vasodilatation
Secondary outcomes:
measure: Psychological burden caused by the intervention
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Pediatrics, University of Turku
Study officials:
affiliation: University of Turku, Turku, Finland
name: Olli G Simell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.