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NCT Number: NCT06357065

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

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.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active transport educational program based on the ecological model

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.

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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

  3. Changes in Executive Function (inhibition) at 16 weeks

    Time frame: 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.

  4. Changes in Executive Function (cognitive flexibility) at 16 weeks

    Time frame: 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.

  5. Changes in executive function (working memory) at 16 weeks

    Time frame: 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

Secondary outcomes

  1. Change from Anthropometric measurements at 16 weeks

    Time frame: 4 months

    The following anthropometric measurements will be obtained: i) body weight in kg with a digital scale (Seca 769, Germany; Accuracy of 0.1 kg); ii) bipedal height in cm with a stadiometer (Seca 220, Germany; Accuracy of 0.1 cm). Weight and height will be combined to report BMI in kg/m^2.

  2. Changes in objective physical activity at 16 week

    Time frame: 4 months

    Measurement of objective physical activity will be by Actigraph Accelerometer - Model wGT3X-BT. They include a microelectromechanical system (MEMS) based accelerometer, ambient light and a touch sensor as data collection endpoints. The study subjects will wear the device for 6 full days. The analysis of the data extracted from the accelerometers will allow to identify and classify the amount (minutes) of physical activity performed according to its intensity (low, moderate and high).

  3. Change from Physical Fitness (Aptitud cardiorrespiratoria (VO2 máx) at 16 weeks

    Time frame: 4 months

    VO2 max will be measured using the 20m shuttle run test, , which allows for a highly reliable and easy-to-use evaluation. . This is a maximal test involving a continuous run between two lines separated by 20 m at the same time as the beeps are recorded. The athlete's score is the level and number of laps (20 m) achieved before he/she could not keep up with the recording. The level score can be converted to an equivalent VO 2max score.

  4. Change from Physical Fitness (lower body strength) at 16 weeks

    Time frame: 4 months

    Lower body strength will be measured using the feet together long jump test, which allows for a highly reliable and easy-to-use evaluation. Test to measure or assess the explosive force (power) of the tensor muscles of the legs. The number of centimeters advanced, from the jump line to the edge closest to the jump line, of the foot that was farthest behind after the fall is recorded. The distance in centimeters becomes a power category.

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

    Time frame: 4 months

    This will be evaluated with the hydraulic dynamometer (Camry, model EH101, China), which allows evaluation of great reliability and easy application. The arm curl test to assess the strength on the upper body, using a 3lb (women) and 5lb (men) dumbbell, counting the number of repetitions made in 30s.

  6. Change from mental health (depression) at 16 weeks

    Time frame: 4 months

    This will be evaluated with the Depression, Anxiety, and Stress Scale (DASS-21). Is an instrument designed to assess the negative emotional states of depres-sion, anxiety, and stress. The depression subscale formed by questions 3, 5, 10, 13, 16, 17, and 21. The total scores cate-gorize each subscale into three levels: mild, mo-derate, and severe. Finally, participants will be classified as no risk (<6) or risk (>6).

  7. Change from mental health (Anxiety) at 16 weeks

    Time frame: 4 months

    This will be evaluated with the Depression, Anxiety, and Stress Scale (DASS-21). Is an instrument designed to assess the negative emotional states of depres-sion, anxiety, and stress. Questions 2, 4, 7, 9, 15, 19, and 20 formed the anxiety subscale. The total scores cate-gorize each subscale into three levels: mild, mo-derate, and severe. Finally, participants will be classified as no risk (<6) or risk (>6).

  8. Change from mental health (Stress) at 16 weeks

    Time frame: 4 months

    This will be evaluated with the Depression, Anxiety, and Stress Scale (DASS-21). Is an instrument designed to assess the negative emotional states of depres-sion, anxiety, and stress. The stress subscale was formed by questions 1, 6, 8, 11, 12, 14, and 18. The total scores cate-gorize each subscale into three levels: mild, mo-derate, and severe. Finally, participants will be classified as no risk (<6) or risk (>6).

  9. Changes in overall academic performance once the intervention is completed

    Time frame: 5 months

    To evaluate this variable, the grades of all subjects from the first academic semester will be considered and compared with that of the second semester (intervention). The rating scale in Chile is from 1 to 7, with 7 being the maximum rating.

  10. Changes in health-related quality of life at 16 weeks

    Time frame: 4 months

    This will be obtained using the Kidscreen-52, which measures the attributes of ten dimensions of health: Physical well-being, Psychological well-being, Moods and emotions, Self-perception, Autonomy, Relationships with parents and home life, Financial resources, Peers and social support, School Environment, Bullying. Each dimension is made up of a series of questions that together give a scale ranging from 0 (the worst health state for that dimension) to 100 (the best health state).

  11. Changes in the Perception of urban environmental characteristics at 16 weeks

    Time frame: 4 months

    To measure the Perception of environmental urban features, the Neighborhood environment walkability scale questionnaire was used. (NEWS). It measures the following eight walkability constructs using 66 questions: residential density, land use mix, access to land use mix, street connectivity, walking and biking infrastructure, aesthetics, safety/traffic hazards and security against crime. Additionally, the questionnaire has questions about individual satisfaction with the neighborhood. Higher scores mean greater perception of the urban environment to promote active transportation.

  12. Changes in physical activity barriers at 16 weeks

    Time frame: 4 months

    The Short scale of perception of barriers for physical activity in adolescents will be used. Twelve-item self-report instrument that asks adolescents to declare to what extent they perceive the different items included in the scale as barriers to not practicing organized sports activities. Each item was assessed with a five-point Likert-type response scale in which 1 means totally disagree and 5 means totally agree.

  13. Changes in adherence to physical activity at 16 weeks

    Time frame: 4 months

    The Physical Activity Questionnaire for Adolescents (PAQ-A) will be completed. Self-report scale, described by its creators as designed for use with scalar students, contains eight items intended to capture adolescents' recall of their physical activity during the previous 7 days. The first and last of the eight items of the PAQ-A each contain a number of sub-items from which a mean is initially calculated, and these two means are added to the responses of the other six items to obtain a total a from which the mean is calculated to produce a composite score ranging from 1 to 5, with higher scores indicating greater PA.Puntuación del examen

  14. Changes in the form of Transportation to and from School (Active Transportation) at 16 weeks.

    Time frame: 4 months

    The questions of the questionnaire will be used based on the PACO Project. The question will be directly asked about the way in which you travel to and from school in the last week. The response options are: Motorized transportation, by bicycle and walking.

Other outcomes

  1. Sociodemographic evaluations of parents

    Time frame: 2 weeks

    Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others).

  2. Parents' perception of urban environmental characteristics

    Time frame: 2 weeks

    To measure the Perception of urban environmental characteristics, the neighborhood environmental walkability scale questionnaire was used. (NEWS parent version). Measures the following eight walkability constructs using 66 questions: residential density, land use mix, access to land use mix, street connectivity, walking and biking infrastructure, aesthetics, safety/traffic hazards, and security against crime. Additionally, the questionnaire has questions about individual satisfaction with the neighborhood. Higher scores mean greater awareness of the urban environment to promote active transportation.

  3. Parents' perception of physical fitness

    Time frame: 2 weeks

    Parents' Self-Perceived Physical Condition Level The International Fitness Scale (IFIS) will be used. Instrument composed of five questions on a Likert scale that ask about the general fitness perceived by adults (general physical condition, respiratory physical condition, strength, speed/agility and flexibility in comparison with physical fitness with people of the same age (very poor, bad, average, good and very good).

Study contacts

Contact information is provided by the study sponsor or research team.

Eugenio Merellano Navarro, Phd.

CONTACT

[email protected]

56982307921

Eugenio N Merellano Navarro

CONTACT

[email protected]

982307921

Sponsors and collaborators

Lead sponsor

Universidad Católica del Maule

Other

Registry information

Official study 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)

Acronym: MOV-ES

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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