Physical Inactivity in Children Clinical Trial
— MOV-ESOfficial 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.
| Status | Not yet recruiting |
| Enrollment | 180 |
| Est. completion date | December 20, 2026 |
| Est. primary completion date | December 20, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 14 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Universidad Católica del Maule |
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* Note: There are 53 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Sociodemographic evaluations of parents | Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others). | 2 weeks | |
| Other | Parents' perception of urban environmental characteristics | 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. | 2 weeks | |
| Other | Parents' perception of physical fitness | 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). | 2 weeks | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | 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. | 4 months | |
| Secondary | 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). | 4 months | |
| Secondary | 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. | 4 months | |
| Secondary | 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. | 4 months | |
| Secondary | 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. | 4 months | |
| Secondary | 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). | 4 months | |
| Secondary | 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). | 4 months | |
| Secondary | 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). | 4 months | |
| Secondary | 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. | 5 months | |
| Secondary | 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). | 4 months | |
| Secondary | 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. | 4 months | |
| Secondary | 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. | 4 months | |
| Secondary | 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 | 4 months | |
| Secondary | 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. | 4 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01024153 -
Active Video Games and Sustainable Physical Activity
|
N/A | |
| Completed |
NCT04116515 -
Active Video Games on Physical Activity (Main Trial)
|
N/A |