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

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ClinicalTrials.gov Identifier: NCT00223600
Recruitment Status : Unknown
Verified August 2005 by University of Turku.
Recruitment status was:  Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : September 19, 2006
Sponsor:
Information provided by:
University of Turku

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Behavioral: Nutritional and life style counseling Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 1062 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Special Turku Atherosclerosis Risk Factor Intervention Project for Children (STRIP)
Study Start Date : May 1990
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Intake of nutrients
  2. Serum lipid and lipoprotein concentrations
  3. Growth and development
  4. Smoking
  5. Physical activity level and fitness
  6. Intima-media thickness of arteries and rate of NO-induced vasodilatation

Secondary Outcome Measures :
  1. Psychological burden caused by the intervention

Eligibility Criteria
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Ages Eligible for Study:   7 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe sickness
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223600


Locations
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Finland
Department of Pediatrics, University of Turku
Turku, Finland, FI-20520
Sponsors and Collaborators
University of Turku
Investigators
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Principal Investigator: Olli G Simell, MD, PhD University of Turku, Turku, Finland
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00223600    
Other Study ID Numbers: STRIP19902010
Academy of Finland (grant)
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: August 2005
Keywords provided by University of Turku:
lipids
lipoproproteins
growth
neurological development
 vascular wall
blood pressure
nutrient intake
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases