Active Transport Educational Program Based on the Ecological Model on Improving the Physical and Mental Health: MOV-ES Project

NCT ID: NCT06357065

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Inactivity in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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MOV-ES group

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.

Group Type EXPERIMENTAL

Active transport educational program based on the ecological model

Intervention Type OTHER

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Active transport educational program based on the ecological model

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica del Maule

OTHER

Sponsor Role lead

Responsible Party

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Eugenio Merellano Navarro

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Eugenio Merellano Navarro, Phd.

Role: CONTACT

56982307921

Eugenio N Merellano Navarro

Role: CONTACT

982307921

References

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Martinez-Gomez D, Gomez-Martinez S, Warnberg J, Welk GJ, Marcos A, Veiga OL. Convergent validity of a questionnaire for assessing physical activity in Spanish adolescents with overweight. Med Clin (Barc). 2011 Jan 15;136(1):13-5. doi: 10.1016/j.medcli.2010.05.013. Epub 2010 Aug 10.

Reference Type BACKGROUND
PMID: 20701933 (View on PubMed)

Ortega FB, Ruiz JR, Espana-Romero V, Vicente-Rodriguez G, Martinez-Gomez D, Manios Y, Beghin L, Molnar D, Widhalm K, Moreno LA, Sjostrom M, Castillo MJ; HELENA study group. The International Fitness Scale (IFIS): usefulness of self-reported fitness in youth. Int J Epidemiol. 2011 Jun;40(3):701-11. doi: 10.1093/ije/dyr039. Epub 2011 Mar 24.

Reference Type BACKGROUND
PMID: 21441238 (View on PubMed)

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Other Identifiers

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11240343

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UCatolicaMaule

Identifier Type: -

Identifier Source: org_study_id

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