Clinical trial NCT06699862: The Use of Competition in a School-based Intervention for Increasing Cardiorespiratory Fitness in Adolescents
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiorespratory Fitness
Mental Health
School-based Intervention
Lead sponsor: University of the Balearic Islands
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Students who belong from "3º ESO" to "1º bachillerato" levels

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: 10 weeks
Secondary outcomes:
measure: Physical activity
timeFrame: 10 weeks
measure: Musculoskeletal fitness (muscular strength)
timeFrame: 10 weeks
measure: Waist circumference
timeFrame: 10 weeks
measure: Height
timeFrame: 10 weeks
measure: Weight
timeFrame: 10 weeks
measure: Body Mass Index (BMI)
timeFrame: 10 weeks
measure: Chronic stress
timeFrame: 10 weeks
measure: Perceived stress
timeFrame: 10 weeks
measure: Sleep quantity and quality
timeFrame: 10 weeks
measure: Self-reported sleep quality
timeFrame: 10 weeks
measure: Autonomous motivation for exercise
timeFrame: 10 weeks
measure: On-task behaviour
timeFrame: 10 weeks
measure: Blood pressure
timeFrame: 10 weeks
measure: Sitting posture
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Palma
country: Spain
facility: University of the Balearic Islands
state: Illes Balears
Study officials:
References: