Clinical trial NCT06357065: Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Physical Inactivity in Children
Keywords: physical activity
active transport
schoolchildren
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 180
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study design, setting: This is a cluster randomized field trial aimed to evaluate the previously tested MOV-ES intervention.

Population: First year of high school students in a city in south-central Chile. Three secondary schools in the urban area of Talca (1 public, 1 private subsidized, and 1 private non-subsidized) with at least three classes per school year will be randomly selected. This methodological option was adopted because, in Chile, school administration is associated with the socioeconomic level of families.
Primary purpose: PREVENTION

Brief summary: 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\&#39;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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Body composition change (fat mass) by bioimpedance at 16 weeks
timeFrame: 4 months
measure: Change from Body Composition (fat-free mass) by bioimpedance at 16 weeks
timeFrame: 4 months
measure: Changes in Executive Function (inhibition) at 16 weeks
timeFrame: 4 months
measure: Changes in Executive Function (cognitive flexibility) at 16 weeks
timeFrame: 4 months
measure: Changes in executive function (working memory) at 16 weeks
timeFrame: 4 months
Secondary outcomes:
measure: Change from Anthropometric measurements at 16 weeks
timeFrame: 4 months
measure: Changes in objective physical activity at 16 week
timeFrame: 4 months
measure: Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks
timeFrame: 4 months
measure: Change from Physical Fitness (lower body strength) at 16 weeks
timeFrame: 4 months
measure: Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks
timeFrame: 4 months
measure: Change from mental health (depression) at 16 weeks
timeFrame: 4 months
measure: Change from mental health (Anxiety) at 16 weeks
timeFrame: 4 months
measure: Change from mental health (Stress) at 16 weeks
timeFrame: 4 months
measure: Changes in overall academic performance once the intervention is completed
timeFrame: 5 months
measure: Changes in health-related quality of life at 16 weeks
timeFrame: 4 months
measure: Changes in the Perception of urban environmental characteristics at 16 weeks
timeFrame: 4 months
measure: Changes in physical activity barriers at 16 weeks
timeFrame: 4 months
measure: Changes in adherence to physical activity at 16 weeks
timeFrame: 4 months
measure: Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks.
timeFrame: 4 months
Other outcomes:
measure: Sociodemographic evaluations of parents
timeFrame: 2 weeks
measure: Parents' perception of urban environmental characteristics
timeFrame: 2 weeks
measure: Parents' perception of physical fitness
timeFrame: 2 weeks
Locations:
Study officials:
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