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

February 8, 2024 updated by: David Sanchez Oliva, University of Extremadura
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.

Study Overview

Detailed Description

MOVESCHOOLS is a randomized controlled 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 randomly assigned to a control group (n = 5 schools and 420 students) and an intervention group (n = 5 schools and 420 students). The intervention will last 6 months, and will consist of three components:

  1. Inclusion of two physically active classes per week.
  2. Development of two daily active breaks of 4 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.

Study Type

Interventional

Enrollment (Estimated)

900

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Cáceres, Spain, 10003
        • Recruiting
        • University of Extremadura
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adolescents in 1st, 2nd and 3rd year of ESO.
  • Adolescents with informed consent 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group will receive the usual academic classes without any methodological modification during the intervention period.
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity and sedentary time
Time Frame: 6 months
Physical activity and sedentary time will be measured through accelerometry (Actigraph GT3X+, Inc., Pensacola, FL, USA).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Musculoskeletal capacity of upper body
Time Frame: 6 months
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.
6 months
Musculoskeletal capacity of lower body
Time Frame: 6 months
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.
6 months
Body composition
Time Frame: 6 months
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.
6 months
Subjective physical fitness
Time Frame: 6 months
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".
6 months
Health status
Time Frame: 6 months
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.
6 months
Self-perceived health
Time Frame: 6 months
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).
6 months
School engagement
Time Frame: 6 months
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).
6 months
Learning perception
Time Frame: 6 months
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).
6 months
Academic performance
Time Frame: 6 months
Academic performance will be evaluated through the marks reported by the schools before and after the intervention.
6 months
Inhibition
Time Frame: 6 months
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.
6 months
Cognitive flexibility
Time Frame: 6 months
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.
6 months
Working memory
Time Frame: 6 months
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.
6 months
Novelty
Time Frame: 6 months
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".
6 months
Enjoyment and boredom
Time Frame: 6 months
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).
6 months
Dietary patterns
Time Frame: 6 months
Adherence to the Mediterranean diet will be measured using the updated version 2.0 of the KIDMED questionnaire.
6 months
Cardiorespiratory capacity
Time Frame: 6 months
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.
6 months
Body mass index
Time Frame: 6 months
Weight and height will be combined to report BMI in kg/m^2.
6 months
Self-reported screen time
Time Frame: 6 months
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.
6 months
School climate
Time Frame: 6 months
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).
6 months
Sociodemographic characteristics
Time Frame: 6 months
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.
6 months
Teachers' perceptions about the feasibility of the intervention program.
Time Frame: 6 months
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.
6 months
Students' perceptions about the feasibility of the intervention program.
Time Frame: 6 months
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.).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

January 31, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CNS2022-135604
  • PID2022-137450OA-I00 (Other Grant/Funding Number: The Spanish Ministry of Science, Innovation and Universities)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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