Clinical trial NCT06258941: Classroom Break, Cognition, and Fitness in Elementary School Children
Official title: Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Healthy Volunteers
Keywords: Executive function
Mindfulness
Interval exercise
Children
Fitness
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 352
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Inhibition speed
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Inhibition accuracy
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Updating speed
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Updating accuracy
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Shifting speed
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Shifting accuracy
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Secondary outcomes:
measure: Aerobic capacity
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Upper body muscle endurance
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Core body muscle endurance
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Flexibility
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Body composition
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
measure: Dispositional mindfulness
timeFrame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Other outcomes:
Locations:
city: Royal Center
country: United States
facility: Pioneer Elementary School
state: Indiana
Study officials:
References: