- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06254638
Effectiveness of a Multicomponent Intervention to Promote Physical Activity Levels During the School Day (MOVESCHOOL) (MOVESCHOOL)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Inclusion of two physically active classes per week.
- Development of two daily active breaks of 4 minutes duration.
- 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:
- 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.
- 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.
- 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.
- 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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Sánchez Oliva, PhD
- Phone Number: 660574338
- Email: davidsanchez@unex.es
Study Contact Backup
- Name: Alberto Grao Cruces, PhD
- Phone Number: +34 956 016768
- Email: alberto.grao@uca.es
Study Locations
-
-
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Cáceres, Spain, 10003
- Recruiting
- University of Extremadura
-
Contact:
- David Sánchez-Oliva, PhD
- Phone Number: 660574338
- Email: davidsanchez@unex.es
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
Studies a U.S. FDA-regulated device product
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