跳至主要内容
临床试验/NCT03236363
NCT03236363已完成不适用

Effectiveness of MOVI Interventions on Improving Adiposity, Cognition and Motor Competence by Increasing Aerobic Cardiorespiratory Fitness: MOVI-da10!

University of Castilla-La Mancha2 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2017年9月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
370
试验地点
2
主要终点
Executive function

研究概览

简要总结

Project which objective is to test the effectiveness of a classroom-based physical activity intervention (MOVI-da10!) on improving, body composition, cardio-respiratory fitness and executive function.

详细描述

In the last decade, this research group has tested the effectiveness of three interventions following after-school intervention model. The first one (MOVI) was carried out in peripuberal age children (4th and 5th year of primary education, 8-11 years) and showed a moderate effect in reducing the adiposity of schoolchildren with higher BMI, an improvement of the lipid profile, without significantly improving the global cardiometabolic risk because it did not produce a reduction in insulinemia.

The second edition (MOVI-2), carried out at schoolchildren of the same age range, increased the duration and intensity of the sessions, and was focused on the development of muscular strength in order to improve insulinemia levels. The intervention showed proved effectiveness; in addition, the data from this intervention showed a modest improvement in girls' aerobic capacity, but not in boys.

The last edition (MOVI-KIDS) was aimed at children aged 4 to 7 years to test the hypotheses that vigorous physical activity at early ages could produce lifelong cardio-metabolic benefits. Data submitted for publication in this study show that, as in the case of the IDEFICS study in children of similar age, the intervention was not effective in improving fitness.

This new edition (MOVI-da10!) has been designed following integrated physical activity intervention and active breaks designs, and as a controlled cluster-randomized trial including 9 schools from Cuenca province, Spain. Six schools will be randomized to the two intervention groups (IG), where the intervention of MOVI-da10! will be conducted for third grade preschool children (about 5 years old), using two different design. Three of them will receive an active breaks intervention, in which twice a day a 10 minutes breaks standard physical activity will be developed, and the other three will receive twice a day a 10 minutes of enriched physical activity integrated in the curriculum. The other three schools will be allocated to the control group (CG).

During an academic year the MOVIda10! interventions will consist of: i) an integrated across the curriculum cognitive demanding physical activity program including two active breaks lasting 10 min, five days/week; and ii) an active breaks physical activity program including two active breaks lasting 10 min, five days/week. In the CG regular physical activity will continue.

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
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Schools must have at least one full classrooms for the 3rd year of preschool.
  • The approval of boards of governors will be necessary to participate in the intervention and in the measurements at the beginning and end of academic year.
  • Children's parents or legal representatives will sign an informed consent to participate.
  • Children's parents will be invited to collaborate by filling in questionnaires with regard to family leisure habits, sleeping, eating and getting around town.

排除标准

  • Children with severe Spanish language learning difficulties.
  • Children with serious physical or mental disorders identified by parents or teachers that would impede participation in the programme's activities
  • Children diagnoses of chronic disorders, such as heart disease, diabetes or asthma, which in the opinion of their paediatricians would prevent their participation in the programme's activities (MOVI-da10!).

研究组 & 干预措施

MOVI-da 10! active breaks

Experimental

It is a physical activity intervention that consists on two daily physical activity active breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

干预措施: MOVI-da10! active breaks (Behavioral)

Control

No Intervention

No intervention

MOVI-da10! integrated physical activity

Experimental

It is an integrated physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children

干预措施: MOVI-da10! integrated physical activity (Behavioral)

结局指标

主要结局

Executive function

时间窗: One year

Executive function will be measured by standardized test using the NIH toolbox

次要结局

  • VO2 max(One year)
  • Body fat%(One year)
  • Motor skills(One year)
  • Health-related quality of life(One year)

研究者

发起方
University of Castilla-La Mancha
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验