Cardiorespratory FitnessB2L-MNCT06699862
The Use of Competition in a School-based Intervention for Increasing Cardiorespiratory Fitness in Adolescents
A study testing High Intensity Interval Training and High Intensity Interval Training with Competition in people with Cardiorespratory Fitness and Mental Health, run by University of the Balearic Islands at 1 site in Spain.
Trial summary
Regular physical activity offers numerous physical, psychological, and cognitive health benefits. However, physical inactivity among adolescents remains a global concern, with 81% of 11- to 17-year-olds failing to meet WHO's recommendation of at least one hour of moderate- to vigorous-intensity activity daily. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiorespratory Fitness, Mental Health, School-based Intervention
- What is being tested?
- High Intensity Interval Training and High Intensity Interval Training with Competition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students who belong from "3º ESO" to "1º bachillerato" levels
Who cannot join
- Students with a health or medical condition that would preclude participation in vigorous physical activity will be excluded from the study but will still participate in normal lessons adapted by the PE teacher
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Competition to Increase the Engagement in a Time-efficient School-based Intervention for Increasing Cardiorespiratory Fitness in Older Adolescents: the Burn 2 Learn - Mallorca Cluster Randomized Controlled Trial
Regular physical activity offers numerous physical, psychological, and cognitive health benefits. However, physical inactivity among adolescents remains a global concern, with 81% of 11- to 17-year-olds failing to meet WHO's recommendation of at least one hour of moderate- to vigorous-intensity activity daily. This inactivity contributes to immediate and long-term health risks, as many non-communicable diseases (NCDs) in adulthood are linked to behaviors established during adolescence. Promoting healthy lifestyles early is crucial for lifelong health and disease prevention.
One significant barrier to effective school-based physical activity programs, such as High-Intensity Interval Training (HIIT), is maintaining student motivation. Low engagement often results in poor adherence. Integrating competition-focused on effort rather than performance-may enhance student participation and make HIIT interventions more effective and easier to implement.
Read more
This study will evaluate the impact of competition on the Burn 2 Learn - Mallorca (B2L-M) program, targeting adolescents aged 15-18. The intervention aims to determine whether competition improves engagement and outcomes compared to non-competitive groups. The primary outcome is cardiorespiratory fitness (CRF), while secondary outcomes include muscular strength, physical activity levels, body composition, mental health (stress and sleep quality), behavior change mediators (self-efficacy, motivation), on-task behavior, blood pressure, and sitting posture.
The B2L-M intervention will involve a 16-week, three-arm cluster randomized controlled trial in Mallorca, Spain, recruiting approximately 360 students from six schools. The program includes teacher-led HIIT sessions twice weekly during physical education, supported by information seminars, a dedicated website, and parental e-newsletters. Outcomes will be assessed at baseline and after 16 weeks.
- Being tested
- High Intensity Interval Training, High Intensity Interval Training with Competition
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Interval TrainingBehavioural
Throughout the 10-weeks intervention period, B2L-M HIIT sessions will be delivered during regular PE classes twice a week, by the schools' PE teachers. The HIIT sessions will be applied in the first 8-10 min of each PE class, including a brief warm-up involving a combination of aerobic and body weight muscle-strengthening exercises, and designed to be fun and engaging as well as vigorous in nature
High Intensity Interval Training with CompetitionBehavioural
Students will participate in a school competition to win points for their class for a 10-week period. In every HIIT session the heart rate will be tracked to measure the exercise intensity and also it will be used to win points for the competition. Every class will receive the same number of points as the sum of the minutes of exercise at a vigorous intensity (i.e., ≥85% max. heart rate) of each participant. This fact means that the physical fitness is irrelevant to the competition aspect, which will only consider the effort of the participants.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | During the 10-week intervention period, the control group will continue their regular physical education (PE) classes, taught by the schools' PE teachers following the standard curriculum. |
| Experimental condition 1: HIIT without competition (HIIT) | Experimental | In the experimental group, Burn 2 Learn - Mallorca (B2L-M) HIIT sessions will be incorporated into regular PE classes twice a week, delivered by the schools' PE teachers. Each session will last 8-10 minutes at the start of class and include a brief warm-up with a mix of aerobic and bodyweight muscle-strengthening exercises. The sessions are designed to be both vigorous and enjoyable to maximize student engagement. Receives: Behavioral: High Intensity Interval Training |
| Experimental condition 2: HIIT with competition (HIIT+C) | Experimental | A key challenge of HIIT is motivating students to maintain high-intensity effort (≥85% of maximum heart rate). To address this, the second experimental condition introduces a competitive element as a motivational strategy. Students will participate in a 10-week school competition to earn points for their class. During each HIIT session, heart rate data will be tracked to monitor exercise intensity and calculate competition points. Each class will earn points equal to the total minutes of vigorous exercise (≥85% of maximum heart rate) achieved collectively by its members.
The competition focuses exclusively on effort rather than physical fitness, ensuring that all participants can contribute equally regardless of their initial fitness levels. This approach emphasizes engagement and teamwork while encouraging students to give their best effort during the sessions. Receives: Behavioral: High Intensity Interval Training with Competition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
CRF will be assessed using the ALPHA (Assessing Levels of Physical Fitness and Health in Adolescents) health-related fitness test battery for children and adolescents. Participants are required to run between two lines 20 m apart in time with an audio signal. The initial speed of the signal is 8.5 km/h and increases by 0.5 km/h per minute. The test ends when the participant fails to reach the end lines in sync with the audio signal on two consecutive occasions or stops due to fatigue. The total number of laps will be used to estimate maximal aerobic capacity (i.e., VO₂ max).
Measured: 10 weeks
Secondary outcomes (14)
Physical activity
The investigators will assess physical activity using tri-axial ActiGraph wGT3X-BT accelerometers (ActiGraph LLC, Pensacola, FL, USA). ActiGraph sensors have been widely studied and shown adequate reproducibility, validity and feasibility for children and adolescents. Participants will wear the accelerometer for seven consecutive days, including weekdays and weekends, except during water-based activities such as swimming or showering. The device will be worn on the wrist of the non-dominant hand. This technique is one of the most reliable methods to quantitatively record and store physical activity data. Physical activity intensity will be categorized into light, moderate, and vigorous levels based on established thresholds.
Measured: 10 weeks
Musculoskeletal fitness (muscular strength)
Lower body musculoskeletal fitness will be assessed through the standing long jump test, which is considered a general index of muscular fitness in youth. Participants will jump as far as they can from a starting point behind a marked line.
Measured: 10 weeks
Waist circumference
Waist circumference will be measured in centimeters using a non-extendible steel tape.
Measured: 10 weeks
Height
Height will be measured in centimeters using a portable stadiometer.
Measured: 10 weeks
Weight
Weight will be measured in kilograms using a portable digital scale.
Measured: 10 weeks
Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m^2).
Measured: 10 weeks
Chronic stress
Chronic stress levels will be analyzed in a sub-sample of students (n = 200). Stress can be accurately assessed by determining the accumulation of cortisol within the hair shaft using a sample taken from the vertex at the back of the head. As human hair grows at approximately 1 cm per month, each cm reflects the stressors experienced in the corresponding month. Cortisol concentrations will be determined from the 3 cm hair segment closest to the scalp, representing cumulative stress levels over the previous 2-3 months. The intra-individual stability (r = 0.68-0.79) and validity of hair cortisol as a retrospective measure of stress are well-supported in the adolescent literature.
Measured: 10 weeks
Perceived stress
Perceived stress will be self-reported using the European Spanish version of the Perceived Stress Scale, which is designed to assess the degree to which situations in one's life are stressful. Participants will be required to respond to the 10-item questionnaire in relation to the previous month. Responses are scored on a 5-point scale ranging from 0 'never' to 4 'very often' and then summing across all scale items. Higher scores indicate a greater degree of subjective stress experienced by participants
Measured: 10 weeks
Sleep quantity and quality
Sleep quantity and quality will be objectively measured using data provided by wrist-worn accelerometry. Sleep will be analyzed according to the algorithm developed by Sadeh. Sleep quality will be represented by sleep efficiency (SE), sleep onset latency (SOL), and time awake per hour after sleep onset (TAPH).
Measured: 10 weeks
Self-reported sleep quality
The Spanish version of the self-reported Pittsburgh Sleep Quality Index (PSQI) will be administered. This standardized clinical instrument covers a broad range of sleep quality indicators. It comprises 19 items evaluating seven components: sleep duration, sleep disturbance, sleep latency, daytime dysfunction due to sleepiness, sleep efficiency, overall sleep quality, and the use of sleep medication. Using a predefined formula, the PSQI score will range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: 10 weeks
Autonomous motivation for exercise
Intrinsic (e.g., "I exercise because it's fun") and identified (e.g., "I value the benefits of exercise") motivation will be assessed using subscales from the Spanish version of the Behavioral Regulations in Exercise Questionnaire. Responses will be scored on a 5-point scale ranging from 0, "Not true for me," to 4, "Very true for me."
Measured: 10 weeks
On-task behaviour
On-task and off-task behavior will be assessed during regular classroom activities using established observation methods. Trained research assistants will conduct 30-minute classroom observations (starting 5 minutes after students enter). They will assess six randomly selected students per session (5 minutes per student). Observers will record student behavior every 10 seconds using an observation sheet, switching to the next student after 15 seconds, and repeating this process until all students have been observed 20 times. Teachers and students will remain unaware of which students are being observed.
On-task behavior includes actively engaging in academic tasks, such as reading, writing, or completing assigned work, as well as passively listening to teachers or peers. Off-task behavior includes motor (e.g., walking around), verbal (e.g., unrelated discussions), and passive (e.g., staring into space) actions unrelated to the task.
Measured: 10 weeks
Blood pressure
Systolic and diastolic blood pressure will be measured using an Omron M3 Blood Pressure Monitor with a cuff size appropriate for each participant's upper arm circumference. Participants will sit quietly for 5 minutes, after which three measurements will be taken at 5-minute intervals. The analysis will use the average of the three readings.
Measured: 10 weeks
Sitting posture
Posture will be assessed using the UPRIGHT Go Posture Training Device (Upright Technologies Ltd., Yehud, Israel). The device will be positioned at the cervicothoracic junction, just below the first prominent spinous process, using the Upright Necklace. It will record posture during an entire classroom session, reporting the percentage of time spent upright versus slouched. The device pairs with a smartphone app, enabling progress tracking toward improved posture.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Mar 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespratory FitnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Balearic Islands
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699862
- Sponsor's protocol ID
- 385CER23
- Acronym
- B2L-M
- Status last verified
- Nov 2024
- First submitted
- 7 Nov 2024
- Last updated
- 21 Nov 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 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Competition to Increase the Engagement in a Time-efficient School-based Intervention for Increasing Cardiorespiratory Fitness in Older Adolescents: the Burn 2 Learn - Mallorca Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06699862
- Acronym / sponsor ID
- B2L-M / 385CER23
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of the Balearic IslandsUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 21 Nov 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.
Regular physical activity offers numerous physical, psychological, and cognitive health benefits. However, physical inactivity among adolescents remains a global concern, with 81% of 11- to 17-year-olds failing to meet WHO's recommendation of at least one hour of moderate- to vigorous-intensity activity daily. This inactivity contributes to immediate and long-term health risks, as many non-communicable diseases (NCDs) in adulthood are linked to behaviors established during adolescence. Promoting healthy lifestyles early is crucial for lifelong health and disease prevention.
One significant barrier to effective school-based physical activity programs, such as High-Intensity Interval Training (HIIT), is maintaining student motivation. Low engagement often results in poor adherence. Integrating competition-focused on effort rather than performance-may enhance student participation and make HIIT interventions more effective and easier to implement.
This study will evaluate the impact of competition on the Burn 2 Learn - Mallorca (B2L-M) program, targeting adolescents aged 15-18. The intervention aims to determine whether competition improves engagement and outcomes compared to non-competitive groups. The primary outcome is cardiorespiratory fitness (CRF), while secondary outcomes include muscular strength, physical activity levels, body composition, mental health (stress and sleep quality), behavior change mediators (self-efficacy, motivation), on-task behavior, blood pressure, and sitting posture.
The B2L-M intervention will involve a 16-week, three-arm cluster randomized controlled trial in Mallorca, Spain, recruiting approximately 360 students from six schools. The program includes teacher-led HIIT sessions twice weekly during physical education, supported by information seminars, a dedicated website, and parental e-newsletters. Outcomes will be assessed at baseline and after 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –During the 10-week intervention period, the control group will continue their regular physical education (PE) classes, taught by the schools' PE teachers following the standard curriculum. |
| Experimental condition 1: HIIT without competition (HIIT) | Experimental | Behavioral: High Intensity Interval TrainingIn the experimental group, Burn 2 Learn - Mallorca (B2L-M) HIIT sessions will be incorporated into regular PE classes twice a week, delivered by the schools' PE teachers. Each session will last 8-10 minutes at the start of class and include a brief warm-up with a mix of aerobic and bodyweight muscle-strengthening exercises. The sessions are designed to be both vigorous and enjoyable to maximize student engagement. |
| Experimental condition 2: HIIT with competition (HIIT+C) | Experimental | Behavioral: High Intensity Interval Training with CompetitionA key challenge of HIIT is motivating students to maintain high-intensity effort (≥85% of maximum heart rate). To address this, the second experimental condition introduces a competitive element as a motivational strategy. Students will participate in a 10-week school competition to earn points for their class. During each HIIT session, heart rate data will be tracked to monitor exercise intensity and calculate competition points. Each class will earn points equal to the total minutes of vigorous exercise (≥85% of maximum heart rate) achieved collectively by its members. The competition focuses exclusively on effort rather than physical fitness, ensuring that all participants can contribute equally regardless of their initial fitness levels. This approach emphasizes engagement and teamwork while encouraging students to give their best effort during the sessions. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students who belong from "3º ESO" to "1º bachillerato" levels
Key exclusion criteria (1 listed)
- Students with a health or medical condition that would preclude participation in vigorous physical activity will be excluded from the study but will still participate in normal lessons adapted by the PE teacher
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 |
|---|---|---|
| High Intensity Interval TrainingThroughout the 10-weeks intervention period, B2L-M HIIT sessions will be delivered during regular PE classes twice a week, by the schools' PE teachers. The HIIT sessions will be applied in the first 8-10 min of each PE class, including a brief warm-up involving a combination of aerobic and body weight muscle-strengthening exercises, and designed to be fun and engaging as well as vigorous in nature | Behavioural | Experimental condition 1: HIIT without competition (HIIT) |
| High Intensity Interval Training with CompetitionStudents will participate in a school competition to win points for their class for a 10-week period. In every HIIT session the heart rate will be tracked to measure the exercise intensity and also it will be used to win points for the competition. Every class will receive the same number of points as the sum of the minutes of exercise at a vigorous intensity (i.e., ≥85% max. heart rate) of each participant. This fact means that the physical fitness is irrelevant to the competition aspect, which will only consider the effort of the participants. | Behavioural | Experimental condition 2: HIIT with competition (HIIT+C) |
Primary outcome
Cardiorespiratory fitness
Time frame: 10 weeks
CRF will be assessed using the ALPHA (Assessing Levels of Physical Fitness and Health in Adolescents) health-related fitness test battery for children and adolescents. Participants are required to run between two lines 20 m apart in time with an audio signal. The initial speed of the signal is 8.5 km/h and increases by 0.5 km/h per minute. The test ends when the participant fails to reach the end lines in sync with the audio signal on two consecutive occasions or stops due to fatigue. The total number of laps will be used to estimate maximal aerobic capacity (i.e., VO₂ max).
14 secondary outcomes
Physical activity
Time frame: 10 weeks
Musculoskeletal fitness (muscular strength)
Time frame: 10 weeks
Waist circumference
Time frame: 10 weeks
Height
Time frame: 10 weeks
Weight
Time frame: 10 weeks
Body Mass Index (BMI)
Time frame: 10 weeks
Chronic stress
Time frame: 10 weeks
Perceived stress
Time frame: 10 weeks
Sleep quantity and quality
Time frame: 10 weeks
Self-reported sleep quality
Time frame: 10 weeks
Autonomous motivation for exercise
Time frame: 10 weeks
On-task behaviour
Time frame: 10 weeks
Blood pressure
Time frame: 10 weeks
Sitting posture
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Interval Training and High Intensity Interval Training with Competition in people with Cardiorespratory Fitness and Mental Health, run by University of the Balearic Islands 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: 10 weeks). 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 21 Nov 2024.