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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00223600
• Other study ID #: STRIP19902010
• Secondary ID: Academy of Finla
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 18, 2006
• Start date: May 1990
• Est. completion date: August 2005

Study information

• Verified date: August 2005
• Source: University of Turku
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1062
• Est. completion date: August 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Months to 7 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• severe sickness

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Behavioral:
• Nutritional and life style counseling

Locations

Country	Name	City	State
Finland	Department of Pediatrics, University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Anglé S, Keskinen S, Lapinleimu H, Helenius H, Raittinen P, Rönnemaa T, Simell O. Weight gain since infancy and prepubertal body dissatisfaction. Arch Pediatr Adolesc Med. 2005 Jun;159(6):567-71. — View Citation

Hakanen M, Rönnemaa T, Talvia S, Rask-Nissilä 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. — View Citation

Ruottinen S, Karjalainen S, Pienihäkkinen K, Lagström H, Niinikoski H, Salminen M, Rönnemaa T, Simell O. Sucrose intake since infancy and dental health in 10-year-old children. Caries Res. 2004 Mar-Apr;38(2):142-8. — View Citation

Viikari JS, Niinikoski H, Juonala M, Raitakari OT, Lagström H, Kaitosaari T, Rönnemaa T, Simell O. Risk factors for coronary heart disease in children and young adults. Acta Paediatr Suppl. 2004 Dec;93(446):34-42. Review. — View Citation

Volanen I, Raitakari OT, Vainionpää R, Arffman M, Aarnisalo J, Anglé 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. Epub 2005 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of nutrients
Primary	Serum lipid and lipoprotein concentrations
Primary	Growth and development
Primary	Smoking
Primary	Physical activity level and fitness
Primary	Intima-media thickness of arteries and rate of NO-induced vasodilatation
Secondary	Psychological burden caused by the intervention