Classroom Break, Cognition, and Fitness in Elementary School Children
ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age8-12
SponsorPurdue University
About this trial
The goal of this randomized controlled trial is to learn about the effect of a 12-week school-based intervention combining mindfulness with high-intensity interval training (MF-HIIT), MF-only intervention, and HIIT-only intervention in relative to sedentary activities on executive function (EF) in 8-12 years old children. The main question it aims to answer is whether a 12-week school-based MF-HIIT intervention has larger beneficial effect on EF performance than that following a 12-week school-based MF-only and HIIT-only in relative to the sedentary activities.
Multiple cohorts of participants will be recruited to participate this one-semester study, including the pretest, intervention, and posttest phases.
During the pretest phase, participants an their parents will complete the following
1. Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient 2. Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index 3. Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness 4. Computerized tasks to assess EF 5. Parent-reported demographic and health information
Following the pretest phase, participants will receive the 12-week classroom-based intervention, with the classroom as the intervention unit.
Following the intervention and during the posttest phase, participants will complete the fitness, measures, EF measures, and dispositional mindfulness measure again.
Researcher will compare the EFn outcome measures following the MF-HIIT, MF-only, and HIIT-only interventions with the sedentary activity intervention to see if MF and HIIT has beneficial effects on children's EF.
Further, researcher will compare the EF measures following the MF-HIIT compared with MF-only and HIIT-only interventions to see if combining MF with HIIT has greater beneficial effects on children's EF than MF and HIIT alone.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 8-12 years old
Intelligence Quotient ≥ 70
Capable of performing exercise based on pre-participation health screening
No formal diagnosis of neurological diseases (e.g., epilepsy)
Disqualifiers
Age outside of the range of 8-12 years old
Intelligence Quotient < 70
No capable of performing exercise based on pre-participation health screening
Has formal diagnosis of neurological diseases (e.g., epilepsy)
Trial design
Design model
Parallel
Treatments tested in this trial
MF-HIIT
BehavioralTwo 10-min MF-HIIT sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.
HIIT-only
BehavioralTwo 10-min HIIT-only sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.
MF-only
BehavioralTwo 10-min MF-only sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.
Sedentary activity
BehavioralTwo 10-min sedentary sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.
Treatment groups
352 Participants
are divided into 4 treatment groupsGroup A: 12-Week Mindful High-Intensity Interval Training (MF-HIIT)Experimental treatment 1 intervention
Group B: 12-Week High-Intensity Interval Training (HIIT-only)Active comparator 1 intervention
Group C: 12-Week Mindfulness (MF-only)Active comparator 1 intervention
Group D: 12-Week Sedentary ActivitiesPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Inhibition speed
Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends2
Inhibition accuracy
Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends3
Updating speed
Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends4
Updating accuracy
Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention endsSecondary outcomes
1
Aerobic capacity
Aerobic capacity will be assessed by the Progressive Aerobic Cardiovascular Endurance Run (PACER) test
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends2
Upper body muscle endurance
Upper body muscle endurance will be assessed by the push-ups test
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends3
Core body muscle endurance
Core body muscle endurance will be assessed by the curl-ups test
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends4
Flexibility
Flexibility will be assessed by the back-saver sit and reach test
Time frame
At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention endsSponsors and contacts
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Source ClinicalTrials.gov