Clinical trial NCT06374732: The Benefits of a High-intensity Interval Training Intervention Delivered in a School Setting Among Adolescents
Official title: Effectiveness of a School-based High-intensity Interval Training Intervention in Adolescents: the PRO-HIIT Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: school
adolescents
high-intensity interval training
randomised control trial
physical activity
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: China Scholarship Council
name: Ningbo University
First posted: 2024-04-19
Enrollment: 369
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 12-week school-based high-intensity interval training intervention, with 8 classes of year 7 students randomly allocated to either intervention or control group. The interval training sessions will last for 6 to 10 minutes and will be delivered 5 times per week. Outcome variables will be physical activity, body composition, cardiorespiratory fitness, muscular strength, bone health, executive function, mental wellbeing, and academic performance, which will be measured pre- and post-intervention and two months after the intervention has been completed.

Detailed description: The purpose of this study is to: 1) evaluate the effectiveness of a 12-week school-based HIIT intervention on cardiorespiratory fitness (primary outcome), physical activity, body composition, muscular strength, bone health, executive function, wellbeing, enjoyment, affect, self-efficacy and academic performance among 12-13-year-old adolescents; 2) to examine the changes of these outcomes following a two-month unstructured summer holiday after the study has been completed; 3) to conduct a process evaluation for the study.

The study is a 12-week high-intensity interval training intervention, which is 6 to 10-minute in length and will be delivered 5 times per week among year 7 adolescents, at the start of physical education and physical activity lessons. We will examine the effectiveness of this intervention on outcomes, such as body composition, cardiorespiratory fitness, muscular health, bone health, cognitive function, mental wellbeing, and academic performance. In addition, The investigators will evaluate the fitness changes between school days (structured day) and a two-month summer holiday (unstructured days). This will be achieved by collecting data at three timepoints: pre- and post-intervention and after a 2-month (summer holiday) following the completion of the intervention.

The high-intensity interval training includes resistance-based exercises, such as jumping jacks, high knees, burpees, squat jumps, lunge jumps, and mountain climbers.

Eligibility criteria: Inclusion Criteria:

• Year 7 students

Exclusion Criteria:

* Unable to perform high-intensity exercises due to existing medical contraindications
* Unable to understand the study procedures and provide consent

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Secondary outcomes:
measure: Muscular strength
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Wellbeing
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Enjoyment
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Motivation
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Affect
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Academic performance
timeFrame: Baseline and immediately after the intervention
measure: Height
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Weight
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: BMI
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Waist circumference
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Body fat percentage
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Physical activity
timeFrame: Baseline, first week and last week of the intervention and first week following the completion of the intervention.
measure: Bone health
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Perceived physical ability
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Flanker task
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Visual 2-back task
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
measure: Colour-shape switch task
timeFrame: Changes from baseline to immediately after the intervention and two month following the cessation of the intervention.
Other outcomes:
measure: Confounding variables
timeFrame: Maturity, subjectively measured physical activity and sleep will be measured at baseline, immediately after the intervention and two month following the cessation of the intervention.
measure: Interview
timeFrame: immediately after the intervention
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
state: Devon
Study officials:
affiliation: University of Exeter
name: Craig Williams, PhD
role: STUDY_CHAIR
affiliation: Ningbo University
name: Yaodong Gu, PhD
role: STUDY_CHAIR
References: