Physical ActivityACTIVA-MENTENCT06590103
Effectiveness of Integrating Physically Active Learning Through Co-teaching in Extremadura: ACTIVA-MENTE Project
A study testing Physically Active Lessons in people with Physical Activity and Adolescents, run by University of Extremadura at 1 site in Spain.
Trial summary
Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Adolescents, Physical Fitness
- What is being tested?
- Physically Active Lessons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2024to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents in 1st, 2nd, 3rd and 4th year of ESO.
- Adolescents with informed consent signed by the family/guardian.
- Schools with at least 210 students enrolled in 1st, 2nd, 3rd and 4th year of ESO.
- Schools belonging to the Autonomous Community of Extremadura.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Extremadura
Cáceres, 10003
David Sánchez-Oliva, PhD, 660574338, davidsanchez@unex.es
About this study
Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.
Read the detailed description
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:
- Students belonging to the experimental group will improve physical activity and decrease sedentary time during the school day when compared to students belonging to the control group.
- The students belonging to the experimental group will improve in the markers of physical and psychological health when compared to the students belonging to the control group.
- Students in the experimental group will improve their academic and cognitive indicators when compared to students in the control group.
- Students belonging to the experimental group will improve school climate and motivational variables in academic classes when compared to students belonging to the control group.
- Conditions
- Physical Activity, Adolescents, Physical Fitness
- Being tested
- Physically Active Lessons
- Keywords
- Physuca active learning, Motivational variables, Sedentary time, Academic indicators
- Medical subject headings
- Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physically Active LessonsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physically Active Lessons. | Experimental | Physically Active Learning: consists of incorporating physical activity (usually of moderate-vigorous intensity) into the educational content taught in non-physical education academic classes. Receives: Behavioral: Physically Active Lessons |
| Control group | No intervention | The control group will receive the usual academic classes without any methodological modification during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity and sedentary time
Physical activity and sedentary time will be measured by the Fitbit activity wristband version 6.0.
Measured: 8 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 8 months
Body mass index
Weight and height will be combined to report BMI in kg/m^2.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 8 months
Academic performance
Academic performance will be evaluated through the marks reported by the schools before and after the intervention.
Measured: 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".
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Sep 2024
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Consejería de Educación, Ciencia y Formación Profesional. Junta de Extremadura
- Responsible party
- Principal investigator, David Sanchez Oliva, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590103
- Sponsor's protocol ID
- 08/2024
- Acronym
- ACTIVA-MENTE
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Integrating Physically Active Learning Through Co-teaching in Extremadura: ACTIVA-MENTE Project
- ClinicalTrials.gov ID
- NCT06590103
- Acronym / sponsor ID
- ACTIVA-MENTE / 08/2024
- Conditions
- Physical Activity, Adolescents, Physical Fitness
- Keywords
- Physuca active learning, Motivational variables, Sedentary time, Academic indicators
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Collaborators
- Consejería de Educación, Ciencia y Formación Profesional. Junta de Extremadura
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study based on a school-based physically active learning intervention during the school day on physical activity, fitness, health and education outcomes in adolescents.
Detailed description
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:
- Students belonging to the experimental group will improve physical activity and decrease sedentary time during the school day when compared to students belonging to the control group.
- The students belonging to the experimental group will improve in the markers of physical and psychological health when compared to the students belonging to the control group.
- Students in the experimental group will improve their academic and cognitive indicators when compared to students in the control group.
- Students belonging to the experimental group will improve school climate and motivational variables in academic classes when compared to students belonging to the control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physically Active Lessons. | Experimental | Behavioral: Physically Active LessonsPhysically Active Learning: consists of incorporating physical activity (usually of moderate-vigorous intensity) into the educational content taught in non-physical education academic classes. |
| Control group | No intervention | –The control group will receive the usual academic classes without any methodological modification during the intervention period. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Adolescents in 1st, 2nd, 3rd and 4th year of ESO.
- Adolescents with informed consent signed by the family/guardian.
- Schools with at least 210 students enrolled in 1st, 2nd, 3rd and 4th year of ESO.
- Schools belonging to the Autonomous Community of Extremadura.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physically Active LessonsPhysically 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. | Behavioural | Physically Active Lessons. |
Primary outcome
Physical activity and sedentary time
Time frame: 8 months
Physical activity and sedentary time will be measured by the Fitbit activity wristband version 6.0.
13 secondary outcomes
Cardiorespiratory capacity
Time frame: 8 months
Musculoskeletal capacity of Upper body
Time frame: 8 months
Musculoskeletal capacity of lower body
Time frame: 8 months
Body mass index
Time frame: 8 months
Health status
Time frame: 8 months
School engagement
Time frame: 8 months
Learning perception
Time frame: 8 months
Academic performance
Time frame: 8 months
Novelty
Time frame: 8 months
School climate
Time frame: 8 months
Sociodemographic characteristics
Time frame: 8 months
Teachers' perceptions about the feasibility of the intervention program.
Time frame: 8 months
Students' perceptions about the feasibility of the intervention program.
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for Physical Activity
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physically Active Lessons in people with Physical Activity and Adolescents, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Sánchez-Oliva, PhD (660574338, davidsanchez@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity and sedentary time (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.