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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00223600
Enrollment
1062
Registered
2005-09-22
Start date
1990-05-31
Completion date
2005-08-31
Last updated
2006-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

lipids, lipoproproteins, growth, neurological development, vascular wall, blood pressure, nutrient intake

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.

Interventions

BEHAVIORALNutritional and life style counseling

Sponsors

University of Turku
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Months to 7 Months
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* severe sickness

Design outcomes

Primary

MeasureTime frame
Growth and development
Intake of nutrients
Serum lipid and lipoprotein concentrations
Intima-media thickness of arteries and rate of NO-induced vasodilatation
Smoking
Physical activity level and fitness

Secondary

MeasureTime frame
Psychological burden caused by the intervention

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026