跳至主要内容
临床试验/NCT06357065
NCT06357065尚未招募不适用

Effectiveness of the Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health of Secondary Students: Study Protocol for a Randomized Controlled Trial (Mov-Es Project)

Universidad Católica del Maule0 个研究点目标入组 180 人开始时间: 2024年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
主要终点
Body composition change (fat mass) by bioimpedance at 16 weeks

研究概览

简要总结

The epidemic of physical inactivity affects the entire world and is responsible for more than 5 million deaths per year. The call of the United Nations, through the 2030 Agenda and the Sustainable Development Goals, encourages the creation of favorable environments for physical activity based on the ecological model of physical activity. Given this context, active transportation can be an accessible, economical, and sustainable method to increase daily physical activity. The rate of school children who use active transport has decreased, being replaced by motorized transport, causing congestion and high levels of pollution in cities. In the Chilean context, there are studies of active transportation in the Chilean population; however, they are scarce in the school population and none of them is an intervention study, demonstrating the incipient development of this area in the country. The benefits of promoting active transportation not only favor the lifestyles of school children but also include additional co-benefits such as the improvement of mental health and better academic performance, in addition to the reduction of exhaust and greenhouse gas emissions.

Objectives. This proposal consists of three phases with the following objectives: Phase I: i) to synthesize the evidence about interventions aimed at estimating the effect on health of active transport in the secondary students; and ii), using qualitative techniques, to explore, from the basis of grounded theory, barriers and facilitators perceived by professors, students and parents about the development and implementation of the MOV-ES intervention. Phase II. Pilot and feasibility trial: a) to test the effect of MOV-ES intervention on improving body composition (body fat percentage and muscle mass), physical fitness (aerobic capacity and muscular strength), executive function and mental fitness (mood disorders, cognitive functioning) in the secondary students; and b), to examine the acceptability by professors, parents and students of the intervention by using ad hoc questionnaires. Phase III: to test the effectiveness of the MOV-ES intervention on physical activity, physical fitness, cognition and mental health through a cluster randomized controlled trial.

Expected results: This project will give rise to the following master's and doctoral theses, with their corresponding articles of high scientific impact: 1) Barriers and facilitators of teachers, parents and students for active transport from a qualitative approach; 2) Association between the built environment, urban features, and active transportation in high school students, 3) Effectiveness of an active transportation educational intervention on physical fitness and body composition, 4) Effectiveness of an active transportation educational intervention on the cognition of schoolchildren. It is expected that the results of the MOV-ES Project will transcend the physical health of schoolchildren and will have an impact on the school community, especially by decongesting the school environment. Through these results, the Ministry of Education, regional DAEM, municipalities, and educational establishments will be able to propose public policies that favor the practice of physical activity and the acquisition of healthy habits at school age. All of the above is based on quality indicators proposed by the Education Quality Agency.

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
Single (Investigator)

盲法说明

Randomization and blinding procedures: We invited 6 first-year high school classes to participate and, using a computer-generated procedure, will be randomized to the IG and to CG. The participants will be informed of the result of randomization after they agreed to participate in the study. The nature of the intervention makes its blinding infeasible.

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Students in their third year of high school enrolled in schools in the province of Talca

排除标准

  • •Students who have some motor problem to carry out autonomous transportation.

研究组 & 干预措施

MOV-ES group

Experimental

The design of the intervention requires incorporating content that involves intrapersonal (benefits of active transportation and safety on the way to school), interpersonal (family safety), organizational, community, physical-environmental, and political (safety, infrastructure, quality) factors. It will consist of weekly sessions of 60 to 90 minutes each for 16 weeks. The complete program has a duration of 4 months, during school hours in the subject of Physical Education, and on the premises of each establishment. The contents to be worked on will be organized in a Didactic Unit and will include the presentation of graphic and audiovisual material and practical contents. Each session will be designed based on the results of PHASE 1 of the study, following the recommendations of active transport interventions in schoolchildren , and the material available from the PACO Project.

干预措施: Active transport educational program based on the ecological model (Other)

Control group

No Intervention

The CG students will participate in the initial and final measurement, but will not receive any intervention, attending their traditional Physical Education classes.

结局指标

主要结局

Body composition change (fat mass) by bioimpedance at 16 weeks

时间窗: 4 months

The body composition (bioimpedance), the percentage of fat mass will be obtained using eight electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea).

Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks

时间窗: 4 months

The body composition (bioimpedance), the percentage of fat-free mass will be obtained using eight electrode tetrapolar bioimpedance (InBody 570®, Body Composition Analyzers, South Korea). Score Test d'Dimensional Chang Card Sort Test Score Test d'List Sorting Working Memory Test

Changes in Executive Function (inhibition) at 16 weeks

时间窗: 4 months

Inhibitory control and attention will be measured using the Flaker Attention and Inhibitory Control Test (NIH Toolbox). The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. By applying the test, a score of inhibitory control and attention is obtained.

Changes in Executive Function (cognitive flexibility) at 16 weeks

时间窗: 4 months

Cognitive flexibility and attention will be measured using the Dimensional Change Card Sort Test (NIH Toolbox). The participant is asked to match a series of picture pairs to a target picture. A score of cognitive flexibility and attention is obtained by applying the test.

Changes in executive function (working memory) at 16 weeks

时间窗: 4 months

Working memory will be measured using list sorting working memory test. Test available at NIH Toolbox. The participant is asked to recall and sequence different stimuli that are presented visually and via audio. A working memory score is obtained by applying the test

次要结局

  • Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks(4 months)
  • Change from Anthropometric measurements at 16 weeks(4 months)
  • Changes in objective physical activity at 16 week(4 months)
  • Change from mental health (depression) at 16 weeks(4 months)
  • Change from mental health (Anxiety) at 16 weeks(4 months)
  • Change from mental health (Stress) at 16 weeks(4 months)
  • Changes in overall academic performance once the intervention is completed(5 months)
  • Changes in the Perception of urban environmental characteristics at 16 weeks(4 months)
  • Changes in physical activity barriers at 16 weeks(4 months)
  • Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks(4 months)
  • Change from Physical Fitness (lower body strength) at 16 weeks(4 months)
  • Changes in adherence to physical activity at 16 weeks(4 months)
  • Changes in health-related quality of life at 16 weeks(4 months)
  • Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks.(4 months)

研究者

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

Eugenio Merellano Navarro

Research Associate

Universidad Católica del Maule

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