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Clinical Trials/NCT06699862
NCT06699862Active, not recruitingNot Applicable

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

University of the Balearic Islands2 sites in 1 country200 target enrollmentStarted: March 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Cardiorespiratory fitness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
15 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Physical activity(10 weeks)
  • Musculoskeletal fitness (muscular strength)(10 weeks)
  • Waist circumference(10 weeks)
  • Height(10 weeks)
  • Weight(10 weeks)
  • Body Mass Index (BMI)(10 weeks)
  • Chronic stress(10 weeks)
  • Perceived stress(10 weeks)
  • Sleep quantity and quality(10 weeks)
  • Self-reported sleep quality(10 weeks)
  • Autonomous motivation for exercise(10 weeks)
  • On-task behaviour(10 weeks)
  • Blood pressure(10 weeks)
  • Sitting posture(10 weeks)

Investigators

Sponsor
University of the Balearic Islands
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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