Classroom Break, Cognition, and Fitness in Elementary School Children

Official title

Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function

Overview

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.

Interventions

• Behavioral MF-HIIT
  Two 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.
• Behavioral HIIT-only
  Two 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.
• Behavioral MF-only
  Two 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.
• Behavioral Sedentary activity
  Two 10-min sedentary sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon.

Primary outcome measures

• Inhibition speed [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Inhibition accuracy [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Updating speed [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Updating accuracy [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Shifting speed [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Shifting accuracy [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]

Secondary outcome measures (6)

• Aerobic capacity [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Upper body muscle endurance [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Core body muscle endurance [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Flexibility [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Body composition [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]
• Dispositional mindfulness [Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• Pioneer Elementary School — Royal Center

Identifiers

NCT: NCT06258941 · IRB-2024-1588 · 1R21HD110656-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗