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NCT Number: NCT06258941

Classroom Break, Cognition, and Fitness in Elementary School Children

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.

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Key information

Conditions

Healthy Volunteers

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pioneer Elementary School

Royal Center, Indiana, 46978, United States

Location status: Recruiting

Location contact

Pat Principal Quillen

CONTACT

[email protected]

574-643-2255

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MF-HIIT

Behavioral

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.

HIIT-only

Behavioral

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.

MF-only

Behavioral

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.

Sedentary activity

Behavioral

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 outcomes

  1. Inhibition speed

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.

  2. Inhibition accuracy

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.

  3. Updating speed

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.

  4. Updating accuracy

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.

  5. Shifting speed

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Shifting speed will be assessed by the response time (ms) during a child-friendly switching task.

  6. Shifting accuracy

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Shifting accuracy will be assessed by the response accuracy (percent) during a child-friendly switching task.

Secondary outcomes

  1. Aerobic capacity

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Aerobic capacity will be assessed by the Progressive Aerobic Cardiovascular Endurance Run (PACER) test

  2. Upper body muscle endurance

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Upper body muscle endurance will be assessed by the push-ups test

  3. Core 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 will be assessed by the curl-ups test

  4. Flexibility

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Flexibility will be assessed by the back-saver sit and reach test

  5. Body composition

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    body composition will be assessed by the body mass index computed as weight (kg) / (height [m] * height [m])

  6. Dispositional mindfulness

    Time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends

    Dispositional mindfulness will be assessed by the Child and Adolescent Mindfulness Measure questionnaire (CAMM). The questionnaire has 10 items and requires the respondents to rating each item using a 5-point likert scale from 0 (Never True) to 4 (Always True). Higher summed scores indicate higher levels of mindfulness

Study contacts

Contact information is provided by the study sponsor or research team.

Shih-Chun (Alvin) Kao, PhD

CONTACT

[email protected]

765-496-2213

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 14, 2024
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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