NCT06357065

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\'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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

March 27, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Expected
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

March 27, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

physical activityactive transportschoolchildren

Outcome Measures

Primary Outcomes (5)

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

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

    4 months

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

    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

    4 months

  • Changes in Executive Function (inhibition) at 16 weeks

    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.

    4 months

  • Changes in Executive Function (cognitive flexibility) at 16 weeks

    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.

    4 months

  • Changes in executive function (working memory) at 16 weeks

    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

    4 months

Secondary Outcomes (14)

  • Change from Anthropometric measurements at 16 weeks

    4 months

  • Changes in objective physical activity at 16 week

    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

  • Change from Physical-Functional Fitness (strenght on the upper body) at 16 weeks

    4 months

  • +9 more secondary outcomes

Other Outcomes (3)

  • Sociodemographic evaluations of parents

    2 weeks

  • Parents' perception of urban environmental characteristics

    2 weeks

  • Parents' perception of physical fitness

    2 weeks

Study Arms (2)

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.

Other: Active transport educational program based on the ecological model

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.

Interventions

The intervention is structured according to the following units: Unit I: benefits of physical activity on health and healthy habits in schoolchildren; Unit II: Active Transportation: Experiences from other countries; Unit III: Analysis of the environmental characteristics of the school environment of each establishment; and Unit VI: Road safety for pedestrians and cyclists. This last topic will be broken down considering analysis and prevention of accidents with automobiles, pedestrian regulations, signaling, and cyclist safety. The sessions of the last month of intervention (November) will include practical walking activities in the school environment (outside the school). Depending on the possibilities of each school, cycling sessions will be included.

MOV-ES group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (53)

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    PMID: 21441238BACKGROUND

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Eugenio Merellano Navarro, Phd.

CONTACT

Eugenio N Merellano Navarro

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 10, 2024

Study Start

April 1, 2024

Primary Completion

December 20, 2025

Study Completion (Estimated)

December 20, 2026

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share