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Physical Inactivity in ChildrenMOV-ESNCT06357065

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

A study testing Active transport educational program based on the ecological model in people with Physical Inactivity in Children, run by Universidad Católica del Maule.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Physical Inactivity in Children
What is being tested?
Active transport educational program based on the ecological model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 20 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Eugenio Merellano Navarro, Phd. contact

56982307921

emerellano@ucm.cl

Eugenio N Merellano Navarro contact

982307921

emerellano@gmail.com

About this study

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)

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.

Being tested
Active transport educational program based on the ecological model
Keywords
physical activity, active transport, schoolchildren
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active transport educational program based on the ecological modelOther

    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.

Study groups in NCT06357065
Study groupRoleWhat they receive
MOV-ES groupExperimentalThe 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.
Receives: Other: Active transport educational program based on the ecological model
Control groupNo interventionThe CG students will participate in the initial and final measurement, but will not receive any intervention, attending their traditional Physical Education classes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 4 months

  2. 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

    Measured: 4 months

  3. 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.

    Measured: 4 months

  4. 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.

    Measured: 4 months

  5. 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

    Measured: 4 months

Secondary outcomes (14)

  1. Change from Anthropometric measurements at 16 weeks

    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.

    Measured: 4 months

  2. Changes in objective physical activity at 16 week

    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).

    Measured: 4 months

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

    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.

    Measured: 4 months

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

    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.

    Measured: 4 months

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

    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.

    Measured: 4 months

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

    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).

    Measured: 4 months

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

    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).

    Measured: 4 months

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

    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).

    Measured: 4 months

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

    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.

    Measured: 5 months

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

    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).

    Measured: 4 months

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

    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.

    Measured: 4 months

  12. Changes in physical activity barriers at 16 weeks

    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.

    Measured: 4 months

  13. Changes in adherence to physical activity at 16 weeks

    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

    Measured: 4 months

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

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Investigator
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357065
Sponsor's protocol ID
UCatolicaMaule
Other IDs
11240343
Acronym
MOV-ES
Status last verified
Apr 2024
First submitted
27 Mar 2024
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.

    PubMed 22818941

  • Lee IM, Shiroma EJ, Lobelo F, Puska P, Blair SN, Katzmarzyk PT; Lancet Physical Activity Series Working Group. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet. 2012 Jul 21;380(9838):219-29. doi: 10.1016/S0140-6736(12)61031-9.

    PubMed 22818936

  • Aubert S, Barnes JD, Abdeta C, Abi Nader P, Adeniyi AF, Aguilar-Farias N, Andrade Tenesaca DS, Bhawra J, Brazo-Sayavera J, Cardon G, Chang CK, Delisle Nystrom C, Demetriou Y, Draper CE, Edwards L, Emeljanovas A, Gaba A, Galaviz KI, Gonzalez SA, Herrera-Cuenca M, Huang WY, Ibrahim IAE, Jurimae J, Kamppi K, Katapally TR, Katewongsa P, Katzmarzyk PT, Khan A, Korcz A, Kim YS, Lambert E, Lee EY, Lof M, Loney T, Lopez-Taylor J, Liu Y, Makaza D, Manyanga T, Mileva B, Morrison SA, Mota J, Nyawornota VK, Ocansey R, Reilly JJ, Roman-Vinas B, Silva DAS, Saonuam P, Scriven J, Seghers J, Schranz N, Skovgaard T, Smith M, Standage M, Starc G, Stratton G, Subedi N, Takken T, Tammelin T, Tanaka C, Thivel D, Tladi D, Tyler R, Uddin R, Williams A, Wong SHS, Wu CL, Zembura P, Tremblay MS. Global Matrix 3.0 Physical Activity Report Card Grades for Children and Youth: Results and Analysis From 49 Countries. J Phys Act Health. 2018 Nov 1;15(S2):S251-S273. doi: 10.1123/jpah.2018-0472.

    PubMed 30475137

  • Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1.9 million participants. Lancet Glob Health. 2018 Oct;6(10):e1077-e1086. doi: 10.1016/S2214-109X(18)30357-7. Epub 2018 Sep 4.

    PubMed 30193830

  • Aguilar-Farias N, Miranda-Marquez S, Martino-Fuentealba P, Sadarangani KP, Chandia-Poblete D, Mella-Garcia C, Carcamo-Oyarzun J, Cristi-Montero C, Rodriguez-Rodriguez F, Delgado-Floody P, Von Oetinger A, Balboa-Castillo T, Pena S, Cuadrado C, Bedregal P, Celis-Morales C, Garcia-Hermoso A, Cortinez-O'Ryan A. 2018 Chilean Physical Activity Report Card for Children and Adolescents: Full Report and International Comparisons. J Phys Act Health. 2020 Jul 15;17(8):807-815. doi: 10.1123/jpah.2020-0120. Print 2020 Aug 1.

    PubMed 32668409

  • Celis-Morales C, Salas C, Martinez MA, Leiva AM, Garrido-Mendez A, Diaz-Martinez X. [The economic burden of physical inactivity in Chile]. Rev Med Chil. 2017 Aug;145(8):1091-1092. doi: 10.4067/s0034-98872017000801091. No abstract available. Spanish.

    PubMed 29189871

  • Aznar S, Naylor PJ, Silva P, Perez M, Angulo T, Laguna M, Lara MT, Lopez-Chicharro J. Patterns of physical activity in Spanish children: a descriptive pilot study. Child Care Health Dev. 2011 May;37(3):322-8. doi: 10.1111/j.1365-2214.2010.01175.x. Epub 2010 Nov 18.

    PubMed 21083695

  • Stanley RM, Maher C, Dollman J. Modelling the contribution of walking between home and school to daily physical activity in primary age children. BMC Public Health. 2015 May 1;15:445. doi: 10.1186/s12889-015-1765-7.

    PubMed 25928079

  • Costa J, Adamakis M, O'Brien W, Martins J. A Scoping Review of Children and Adolescents' Active Travel in Ireland. Int J Environ Res Public Health. 2020 Mar 18;17(6):2016. doi: 10.3390/ijerph17062016.

    PubMed 32197539

  • Aarts MJ, Mathijssen JJ, van Oers JA, Schuit AJ. Associations between environmental characteristics and active commuting to school among children: a cross-sectional study. Int J Behav Med. 2013 Dec;20(4):538-55. doi: 10.1007/s12529-012-9271-0.

    PubMed 23076641

  • Kek CC, Garcia Bengoechea E, Spence JC, Mandic S. The relationship between transport-to-school habits and physical activity in a sample of New Zealand adolescents. J Sport Health Sci. 2019 Sep;8(5):463-470. doi: 10.1016/j.jshs.2019.02.006. Epub 2019 Feb 28.

    PubMed 31534821

  • Martin A, Boyle J, Corlett F, Kelly P, Reilly JJ. Contribution of Walking to School to Individual and Population Moderate-Vigorous Intensity Physical Activity: Systematic Review and Meta-Analysis. Pediatr Exerc Sci. 2016 Aug;28(3):353-63. doi: 10.1123/pes.2015-0207. Epub 2016 Feb 17.

    PubMed 26882871

  • Salvo D, Garcia L, Reis RS, Stankov I, Goel R, Schipperijn J, Hallal PC, Ding D, Pratt M. Physical Activity Promotion and the United Nations Sustainable Development Goals: Building Synergies to Maximize Impact. J Phys Act Health. 2021 Jul 13;18(10):1163-1180. doi: 10.1123/jpah.2021-0413.

    PubMed 34257157

  • Sarmiento OL, Lemoine P, Gonzalez SA, Broyles ST, Denstel KD, Larouche R, Onywera V, Barreira TV, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS, Katzmarzyk PT. Relationships between active school transport and adiposity indicators in school-age children from low-, middle- and high-income countries. Int J Obes Suppl. 2015 Dec;5(Suppl 2):S107-14. doi: 10.1038/ijosup.2015.27. Epub 2015 Dec 8.

    PubMed 27152178

  • Martin-Moraleda E, Mandic S, Queralt A, Romero-Blanco C, Aznar S. Associations among Active Commuting to School and Prevalence of Obesity in Adolescents: A Systematic Review. Int J Environ Res Public Health. 2022 Aug 31;19(17):10852. doi: 10.3390/ijerph191710852.

    PubMed 36078573

Questions about this trial

What is this clinical trial studying?

A study testing Active transport educational program based on the ecological model in people with Physical Inactivity in Children, run by Universidad Católica del Maule.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eugenio Merellano Navarro, Phd. (56982307921, emerellano@ucm.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body composition change (fat mass) by bioimpedance at 16 weeks (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357065, which also lists 53 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.

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