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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University of Turku.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Turku
ClinicalTrials.gov Identifier:
NCT00223600
First received: September 13, 2005
Last updated: September 18, 2006
Last verified: August 2005

September 13, 2005
September 18, 2006
May 1990
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00223600 on ClinicalTrials.gov Archive Site
Psychological burden caused by the intervention
Same as current
Not Provided
Not Provided
 
Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Atherosclerosis
Behavioral: Nutritional and life style counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1062
August 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • severe sickness
Both
7 Months to 7 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00223600
STRIP19902010, Academy of Finland (grant)
Not Provided
Not Provided
University of Turku
Not Provided
Principal Investigator: Olli G Simell, MD, PhD University of Turku, Turku, Finland
University of Turku
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP