An interventional study of Physically Active Lessons 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.
Sponsored by University of Extremadura · Not applicable, Interventional, and Prevention
Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.
Activamente is a quasi-experimental study coordinated by fully qualified researchers in physical activity and sport sciences from the University of Extremadura (UEX), Spain. This study is aimed at students from 1st to 4th year of Secondary Education (11-16 years old), belonging to 10 schools in the Autonomous Community of Extremadura. Each school will have five experimental groups and five control groups. Thus, there will be 50 experimental groups (n=1100) and 50 control groups (n=1100). The intervention will last 8 months, and will consist of one component, which is the inclusion of one physically active class per week.
Before and after the intervention, physical activity and sedentary time will be assessed by activity bracelets, 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) by specific cognition tests. In addition, two intermediate measures of physical activity levels and sedentary time will be measured.
At the end of the intervention the investigators will determine changes in the main outcome variables. Also, the main hypotheses raised will be:
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
This study's planned enrollment of 800 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →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 →
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physically Active Learning: consists of incorporating physical activity (usually of moderate-vigorous intensity) into the educational content taught in non-physical education academic classes.
Behavioral: Physically Active Lessons
The control group will receive the usual academic classes without any methodological modification during the intervention period.
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 Physical Education teacher) are in charge of designing and delivering the physically active classes.
Physical activity and sedentary time
Physical activity and sedentary time will be measured by the Fitbit activity wristband version 6.0.
Time frame: 8 months
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: 8 months
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: 8 months
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: 8 months
Body mass index
Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 8 months
Health status
General health status is assessed using the visual analog scale that includes the five-dimensional, three-level EuroQol questionnaire (EQ-5D-3L) (Ravens-Sieberer et al., 2010). For this, students are asked to assign a score from 0 to 100 to indicate their perception of their general health status.
Time frame: 8 months
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: 8 months
Learning perception
The perception of learning in the different subjects worked on will be evaluated by means of a questionnaire composed of eight items. Items 1- 4 will assess the dimension "perceived learning" and items 5-8 will measure the dimension "satisfaction with learning". All items will be scored according to a five-point Likert scale, where "1" is (strongly disagree) and "5" is (strongly agree).
Time frame: 8 months
Academic performance
Academic performance will be evaluated through the marks reported by the schools before and after the intervention.
Time frame: 8 months
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: 8 months
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: 8 months
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: 8 months
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: 8 months
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: 8 months
Started Sep 2024 (actual). Primary completion is estimated for Jun 2025, 9 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 9 months is below 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.
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University of Extremadura