ClinicalTrials.gg
RecruitingNCT06254638MOVESCHOOLUpdated Sep 19, 2024

Effectiveness of a Multicomponent Intervention to Promote Physical Activity Levels During the School Day (MOVESCHOOL)

An interventional study of Multicomponent school-based intervention. in Physical Activity, Adolescents and Physical Fitness, sponsored by University of Extremadura. Recruiting at 1 site in Spain. Open to participants aged 11 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Primary conditionMotor Activity(the registry's first term)UnverifiedIs this wrong?Motor Activity is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by University of Extremadura · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2023, registered Jan 2024).
  • Started Sep 2023; still recruiting 3 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
11 Years to 16 Years
Sex
All
01

Study summary

Study based a multicomponent school-based intervention during the school-day (i.e., Physically active learning, active breaks, and active recess) on Physical Activity, health, educational, and cognition outcomes in adolescents.

Read the detailed description

MOVESCHOOLS is a quasi-experimental study coordinated by fully qualified researchers in physical activity and sport sciences from two universities [University of Cadiz (UCA) and University of Extremadura (UEX), Spain]. This study is aimed at year 1 to year 3 from Secondary Education students (11-16 years old), belonging to 10 schools in Spain (5 schools in Cadiz and 5 schools in Caceres). The schools will be assigned to a control group (n = 5 schools and 400 students) and an intervention group (n = 5 schools and 400 students). The intervention will last 6 months, and will consist of three components:

  1. Inclusion of a physically active classes per week.
  2. Development of two daily active breaks of 5 minutes duration.
  3. Implementation of daily active recesses.

Before and after the intervention, Physical Activity and sedentary time will be assessed by accelerometry, health-related fitness levels by field tests, body composition parameters by anthropometry, academic performance by school grades, positive health (quality of life and self-perception of health) by questionnaire, and cognitive parameters (executive functions and mathematical fluency) by specific cognition tests. In weeks 8 and 16, Physical Activity and sedentary time will also be evaluated as intermediate measures.

At the end of the intervention the researchers will determine the changes of the main outcome variables. Likewise, the main hypotheses raised will be:

  1. Students belonging to the experimental group will improve physical activity and will decrease sedentary time during the school-day when comparing to the students belonging to the control group.
  2. Students belonging to the experimental group will result in improved in physical and psychological health markers when comparing to the students belonging to the control group.
  3. Students belonging to the experimental group will result in improved academic indicators and cognitive markers when comparing to the students belonging to the control group.
  4. Students belonging to the experimental group will improve school climate and motivational variables in academic classes compared to students belonging to the control group.
02

Conditions studied

  • Physical Activity
  • Adolescents
  • Physical Fitness
  • Cognition

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Keywords

  • Active Break
  • Physically active learning
  • Active Recess
  • Motivational variables
  • Sedentary time
  • Academic indicators
03

In context

Motor Activity Unverified

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's planned enrollment of 900 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University of Extremadura is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
11 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adolescents in 1st, 2nd and 3rd year of ESO.
  • Adolescents with signed by the family/guardian.
  • Schools with at least 80 students enrolled in 1st, 2nd and 3rd ESO.
  • Schools belonging to the regions of Cáceres and Cádiz.

Exclusion criteria

Exclusion Criteria:

  • Adolescents with any physical disability or health condition that may limit physical activity levels.
  • Schools participating in any other physical activity or health promotion program.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
900 participants (estimated)

Study arms

  • Experimental
    Multicomponent school-based intervention

    The multicomponent intervention will be composed of: Physically Active Learning: consists of incorporating physical activity (usually of moderate-vigorous intensity) into the educational content taught in non-physical education academic classes. Active breaks: consists of short breaks during non-physical education academic classes that include moderate to vigorous intensity physical activity. Active Recess: consists of promoting PA during school breaks. To this end, three strategies will be developed: i) modification of the environment; ii) loose equipment; iii) structured recess. The modification of the environment will consist of providing students with a greater number of spaces for them to be active during recess. Access to sports equipment consists of providing sports equipment to encourage PA practice during recess. Structured recess includes the organization of sports competitions and teacher-led activities.

    Behavioral: Multicomponent school-based intervention.

  • No intervention
    Control Group

    The control group will receive the usual academic classes without any methodological modification during the intervention period.

Interventions

  • BehavioralMulticomponent school-based intervention.

    Physically active learning: this type of intervention is carried out once a week for 1 hour outside the classroom. The teachers of the corresponding subject (with the support of the research team) are in charge of the physically active classes. Active break: the intervention consists of 2 active pauses per day. The development of each pause is carried out through a specific digital platform in which students follow the instructions of an avatar, who is in charge of guiding the realization of the active break. Each active break takes a total of 4 minutes, in which two sets of 20 seconds of work and 10 seconds of rest of four different exercises are performed. Active break: The intervention consists of a daily active break, every school day of the week. The design and supervision of each active break will be carried out by the support technician and the teaching staff based on the students' tastes.

06

What researchers measure

Primary outcomes

  1. Physical activity and sedentary time

    Physical activity and sedentary time will be measured through accelerometry (Actigraph GT3X+, Inc., Pensacola, FL, USA).

    Time frame: 6 months

Secondary outcomes

  1. Cardiorespiratory capacity

    The 20-metres shuttle run test will be used to assess cardiorespiratory fitness. Participants will run the 20-metre distance to the rhythm of a recording. The initial speed is 8.5 km/h and will be increased by 0.5 km/h per section. The race will end when the participant stops due to fatigue or when he/she fails to cross the marked lines to the rhythm of the acoustic signals on two consecutive occasions. The last stage or half stage completed by the competitor will be scored.

    Time frame: 6 months

  2. Musculoskeletal capacity of upper body

    The hand grip test will be used to assess musculoskeletal capacity of upper body. The test shall be performed twice with each hand alternately. The maximum score of each hand in kilograms shall be recorded and the mean value between them shall be calculated.

    Time frame: 6 months

  3. Musculoskeletal capacity of lower body

    Standing broad jump shall be used to assess the musculoskeletal capacity of the lower limbs. The participant shall stand behind a line with feet shoulder width apart. The participant is then asked to jump forward as far as possible with both feet. If he/she rests his/her hands or lifts his/her feet off the ground when landing, the test is invalid. The test shall be performed twice, and the best score recorded in centimetres.

    Time frame: 6 months

  4. Body mass index

    Weight and height will be combined to report BMI in kg/m\^2.

    Time frame: 6 months

  5. Body composition

    Waist circumference shall be measured as a body composition variable with a non-elastic tape placed in the frontal plane at the midpoint between the upper iliac spine and the costal border at the mid-axillary line. The measurement shall be taken twice and the mean of the two measurements shall be recorded.

    Time frame: 6 months

  6. Self-reported screen time

    Self-reported screen time will be assessed using the Youth Leisure-time Sedentary Behaviour Questionnaire (YLSBQ). Five questions will be selected from the original questionnaire and participants will be asked to answer them by selecting the amount of time they spend per day on each question, ranging from 0 minutes to 5 or more hours.

    Time frame: 6 months

  7. Subjective physical fitness

    The International Fitness Scale will be used for the assessment of subjective physical fitness. Participants will be asked to rate each of the fitness components on a 5-point Likert-type scale ranging from: "very poor" (1); "poor" (2); "fair" (3); "good" (4) and "very good".

    Time frame: 6 months

  8. Health status

    The EuroQol five dimensions three levels will be used to assessment of health status (EQ-5D-3L).This questionnaire is composed of the dimensions of: (i) mobility; (ii) self-care; (iii) usual activities; (iv) pain/discomfort and (v) anxiety/depression. The three levels that participants should mark a Likert-type scale correspond to (i) no problem; (ii) some problems; (iii) many problem.

    Time frame: 6 months

  9. Self-perceived health

    Self-perceived health will be measured through the classic self-reported health item, where participants will have to classify their health among the following options: "excellent" (5); "very good" (4); "good" (3); "fair" (2) and "poor" (1).

    Time frame: 6 months

  10. School engagement

    The engagement scale (UWES-S-9) will be used to evaluate school engagement. The UWES-S-9 is composed of nine items that reflect the three dimensions of engagement: (i) vigor; (ii) absorption; and (iii) dedication, each dimension is represented by three items that will be evaluated through a Likert-type scale, ranging from "never" (0 points) to "always" (6 points).

    Time frame: 6 months

  11. Learning perception

    Learning perception in mathematics and in general studies will be assessed by means of a questionnaire consisting of eight items. Items 1- 4 will assess the "perceived learning" dimension and items 5-8 will measure the "satisfaction with learning" dimension. All items will be scored according to a five-point Likert scale, where "1" is (strongly disagree) and "5" is (strongly agree).

    Time frame: 6 months

  12. Academic performance

    Academic performance will be evaluated through the marks reported by the schools before and after the intervention.

    Time frame: 6 months

  13. Inhibition

    Inhibition will be evaluated through the Flanker task protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Time frame: 6 months

  14. Cognitive flexibility

    Cognitive flexibility will be evaluated through the Shifting task protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Time frame: 6 months

  15. Working memory

    Working memory will be evaluated through the N-Back protocol, part of the NIH Examiner programme. This is a computerised programme where the subject answers the tests individually. The algorithm provided by the program, ranging from 0 to 10, which includes accuracy and reaction time, will be recorded.

    Time frame: 6 months

  16. Novelty

    Novelty will be assessed through the Novelty Need Satisfaction Scale. Five of the 19 questions that make up the original scale will be selected and participants will be asked to answer them on a Likert-type scale where 1 = "strongly disagree" and 5 = "strongly agree".

    Time frame: 6 months

  17. School climate

    School climate will be assessed using the students' perception of school climate scale (PACE-33). Fifteen items will be evaluated. All items will be scored according to a five-point Likert scale, where "1" is (strongly disagree) and "5" is (strongly agree).

    Time frame: 6 months

  18. Enjoyment and boredom

    Enjoyment and boredom will be assessed using the Spanish version of The Sport Satisfaction Instrument. This scale is composed of eight items. Participants will have to rate their degree of agreement with the items referring to fun or boredom on a five-point Likert-type scale, ranging from 1 (strongly disagree) to 5 (strongly agree).

    Time frame: 6 months

  19. Dietary patterns

    Adherence to the Mediterranean diet will be measured using the updated version 2.0 of the KIDMED questionnaire.

    Time frame: 6 months

  20. Sociodemographic characteristics

    Sociodemographic characteristics will be measured through the Spanish-adapted version III of The Family Affluence Scale. This scale is composed of six questions . Each question is scored on a categorical scale, and the sum of the scores from the six items result in an aggregate index ranging from 0 to 13.

    Time frame: 6 months

  21. Teachers' perceptions about the feasibility of the intervention program.

    Perception about the suitability and the development of the intervention program (perceptions, barriers, points to improve, strengths...) a semi-structured interview will be conducted with the teachers involved in the intervention.

    Time frame: 6 months

  22. Students' perceptions about the feasibility of the intervention program.

    A discussion group will be developed for each of the proposed interventions with a subsample of students, in order to obtain information on the suitability and development of the intervention programme (perceptions, barriers, areas for improvement, strengths, etc.).

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Aug 2026, 35 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 35 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2024
First posted
Feb 12, 2024
StartActual
Sep 1, 2023
Primary completionEst.
Aug 31, 2026
CompletionEst.
Aug 31, 2026
Last update
Sep 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06254638
Lead sponsor
University of Extremadura
Collaborators
Ministry of Science and Innovation, Spain
Responsible party
David Sanchez Oliva (Assistant professor, University of Extremadura) — Principal investigator
First posted
Feb 12, 2024
Start date
Sep 1, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Aug 31, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

David Sánchez Oliva, PhD
Contact
davidsanchez@unex.es
660574338
Alberto Grao Cruces, PhD
Contact
alberto.grao@uca.es
+34 956 016768

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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