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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
What is being tested?
High Intensity Interval Training and High Intensity Interval Training with Competition
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.

Spain1 site
  • University of the Balearic Islands

    Palma, Balearic Islands, 07122

Other trials in Spain

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 groups in NCT06699862
Study groupRoleWhat they receive
Control GroupNo interventionDuring 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)ExperimentalIn 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)ExperimentalA 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.

  1. 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)
  1. 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

  2. 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

  3. Waist circumference

    Waist circumference will be measured in centimeters using a non-extendible steel tape.

    Measured: 10 weeks

  4. Height

    Height will be measured in centimeters using a portable stadiometer.

    Measured: 10 weeks

  5. Weight

    Weight will be measured in kilograms using a portable digital scale.

    Measured: 10 weeks

  6. Body Mass Index (BMI)

    Weight and height will be combined to report BMI in kg/m^2).

    Measured: 10 weeks

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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.

  1. First posted21 Nov 2024
  2. Study start1 Mar 2024
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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)
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

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.

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