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临床试验/NCT01087411
NCT01087411撤回不适用

A Controlled Study Aiming to Increase Physical Activity and Decrease Risk Bio-markers in Sedentary 8 Year Old Swedish Children Via Physical Activity and Fish Liver Oil Supplementation

Karolinska Institutet2 个研究点 分布在 1 个国家开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in level of physical activity

研究概览

简要总结

The purpose of this study is to study whether a targeted intervention can increase physical activity in inactive 8-yr old children and how it affects secondary measures such as metabolic- and cardiovascular risk factors and markers, self-reported quality of life, BMI, body composition and aerobic work-capacity.

详细描述

Background Between 3 to 5 % of Swedish 10 yr olds are obese and an additional 20 % are over-weight. Being physically inactive in childhood increases the risk for becoming obese both in child- and adulthood and a correlation between BMI and arterial-sclerotic markers can be seen already in childhood. Physical activity (PA) in children improve their insulin sensitivity and reduce metabolic risk regardless of the proportion of fat mass. Published questionnaire data suggests that the level of PA has decreased in children between the years 1968 to 2001.

Study aims To study whether a targeted intervention can increase PA in sedentary 8-yr old children (2nd grade Swedish elementary school) and how it affects secondary measures such as; metabolic- and cardiovascular risk markers; self-reported quality of life, PA and motor skills; BMI; body composition; bone mineral density (BMD); PF. To identify factors of success that could be implemented in schools and pre-schools and in the commune and health-care parent support.

Subjects and methods With informed written consent of parents/caretakers we will screen at selected schools with questionnaires and accelerometers to identify sedentary children. The 30% most inactive children will be offered participation in the study. Cut off values for inactivity is obtained from a large reference-material based on 1800 measurements on 6 - 10 yr old children from the STOPP study. The intervention will be delivered through sessions aiming at developing healthy habits regarding PA and via supplementation with fish liver oil. The sessions will be performed by trained health workers (coaches) and carried out in the families' homes and later on via telephone. All families will meet with their coach during at least 6 times. The coaches will use the technique of Motivational Interviewing (MI). However, extra efforts, such as group work-out sessions and out-door activities, will be made. The individual work with these families is delicate and the intervention staff group will therefore have continuous education and guidance from a qualified MI tutor. All included children will be randomized to equally sized intervention or control group. All outcome measures will be assessed at 0 and 15 weeks (completion) of the intervention. The study is limited by the school semesters. Screening is therefore scheduled to the fall- and intervention program to spring semester.

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 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Level of physical activity below the 30ieth percentile cut off point derived from a large reference population.

排除标准

  • Family not being able to participate in the program or take part in at least the physical activity assessment.
  • Morbidities that affects the outcome parameters.

结局指标

主要结局

Change in level of physical activity

时间窗: screening, 0 and 15 weeks and 12 months

Physical activity, is measured with tri-axis accelerometers of the brand Actigraph model GT3X. Data is collected every 10 seconds during 7 consecutive whole days. It is the most feasible and precise method for the purpose.

次要结局

  • Quality of life scale(0 and 15 weeks)
  • BMI (Body Mass Index)(0 and 15 weeks)
  • Body composition(0 and 15 weeks)
  • Cardiovascular risk markers(0 and 15 seeks)
  • Self reported motor skills(0 and 15 weeks)
  • Self reported physical activity(0 and 15 weeks)
  • Physical fitness(0 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernilla Danielsson

MD

Karolinska Institutet

研究点 (2)

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