Overview

This trial is active, not recruiting.

Condition atherosclerosis
Treatment nutritional and life style counseling
Phase phase 3
Sponsor University of Turku
Start date May 1990
End date August 2005
Trial size 1062 participants
Trial identifier NCT00223600, Academy of Finland (grant), STRIP19902010

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

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

Secondary Outcomes

Measure
Psychological burden caused by the intervention
time frame:

Eligibility Criteria

Male or female participants from 7 months up to 7 months old.

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

Additional Information

Official title Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Principal investigator Olli G Simell, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2006.
Information provided to ClinicalTrials.gov by University of Turku.