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Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)

Primary Purpose

Atherosclerosis

Status
Unknown status
Phase
Phase 3
Locations
Finland
Study Type
Interventional
Intervention
Nutritional and life style counseling
Sponsored by
University of Turku
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring lipids, lipoproproteins, growth, neurological development, vascular wall, blood pressure, nutrient intake

Eligibility Criteria

7 Months - 7 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: children at the age of 7 months and their families, recruited from the general population Exclusion Criteria: severe sickness

Sites / Locations

  • Department of Pediatrics, University of Turku

Outcomes

Primary Outcome Measures

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 Outcome Measures

Psychological burden caused by the intervention

Full Information

First Posted
September 13, 2005
Last Updated
September 18, 2006
Sponsor
University of Turku
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1. Study Identification

Unique Protocol Identification Number
NCT00223600
Brief Title
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

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 1990 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turku

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
lipids, lipoproproteins, growth, neurological development, vascular wall, blood pressure, nutrient intake

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1062 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Nutritional and life style counseling
Primary Outcome Measure Information:
Title
Intake of nutrients
Title
Serum lipid and lipoprotein concentrations
Title
Growth and development
Title
Smoking
Title
Physical activity level and fitness
Title
Intima-media thickness of arteries and rate of NO-induced vasodilatation
Secondary Outcome Measure Information:
Title
Psychological burden caused by the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: children at the age of 7 months and their families, recruited from the general population Exclusion Criteria: severe sickness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olli G Simell, MD, PhD
Organizational Affiliation
University of Turku, Turku, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, University of Turku
City
Turku
ZIP/Postal Code
FI-20520
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
15939857
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.
Results Reference
background
PubMed Identifier
15702668
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.
Results Reference
background
PubMed Identifier
15692096
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.
Results Reference
background
PubMed Identifier
15121941
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.
Results Reference
background
PubMed Identifier
14767171
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.
Results Reference
background
PubMed Identifier
32921196
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.
Results Reference
derived
PubMed Identifier
32209700
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.
Results Reference
derived
PubMed Identifier
30072407
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.
Results Reference
derived
PubMed Identifier
29397160
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.
Results Reference
derived
PubMed Identifier
28727955
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.
Results Reference
derived
PubMed Identifier
28652463
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.
Results Reference
derived
PubMed Identifier
27644174
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.
Results Reference
derived
PubMed Identifier
25982143
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.
Results Reference
derived
PubMed Identifier
25661407
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.
Results Reference
derived
PubMed Identifier
25605660
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.
Results Reference
derived
PubMed Identifier
25411292
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.
Results Reference
derived
PubMed Identifier
25350980
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.
Results Reference
derived
PubMed Identifier
24370194
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.
Results Reference
derived
PubMed Identifier
23801725
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.
Results Reference
derived
PubMed Identifier
23753102
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.
Results Reference
derived
PubMed Identifier
23613255
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.
Results Reference
derived
PubMed Identifier
22789807
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.
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derived
PubMed Identifier
22331346
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.
Results Reference
derived
PubMed Identifier
21969011
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.
Results Reference
derived
PubMed Identifier
21474838
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.
Results Reference
derived
PubMed Identifier
20197510
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.
Results Reference
derived
PubMed Identifier
19364991
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.
Results Reference
derived
PubMed Identifier
19158205
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.
Results Reference
derived
PubMed Identifier
18762502
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.
Results Reference
derived
PubMed Identifier
18519471
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.
Results Reference
derived
PubMed Identifier
17548727
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.
Results Reference
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Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)

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