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

Study Overview
=================
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.

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

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Behavioral: Nutritional and life style counseling


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

Ages Eligible for Study
-----------------
Minimum Age: 7 Months
Maximum Age: 7 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Nutritional and life style counseling|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological burden caused by the intervention |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lipids, lipoproproteins, growth, neurological development, vascular wall, blood pressure, nutrient intake