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临床试验/NCT00223600
NCT00223600Unknown3 期

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

University of Turku2 个研究点 分布在 1 个国家目标入组 1,062 人开始时间: 1990年5月最近更新:
适应症

试验速览

阶段
3 期
入组人数
1,062
试验地点
2
主要终点
Intake of nutrients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
7 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • severe sickness

结局指标

主要结局

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

次要结局

  • Psychological burden caused by the intervention

研究者

申办方类型
Other

研究点 (2)

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