Healthy VolunteersPhase 1/2NCT06258941
Classroom Break, Cognition, and Fitness in Elementary School Children
A Phase 1/2 study testing MF-HIIT, HIIT-only and MF-only in people with Healthy Volunteers, run by Purdue University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MF-HIIT, HIIT-only and MF-only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 352 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 31 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pioneer Elementary School
Royal Center, Indiana, 46978
Pat Principal Quillen, 574-643-2255, quillenp@pioneer.k12.in.us
About this study
Official title: Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
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.
Read more
During the pretest phase, participants an their parents will complete the following
- Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
- Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
- Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
- Computerized tasks to assess EF
- 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.
- Conditions
- Healthy Volunteers
- Being tested
- MF-HIIT, HIIT-only, MF-only, Sedentary activity
- Keywords
- Executive function, Mindfulness, Interval exercise, Children, Fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF-HIITBehavioural
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-onlyBehavioural
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-onlyBehavioural
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 activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 12-Week Mindful High-Intensity Interval Training (MF-HIIT) | Experimental | Not described Receives: Behavioral: MF-HIIT |
| 12-Week High-Intensity Interval Training (HIIT-only) | Active comparator | Not described Receives: Behavioral: HIIT-only |
| 12-Week Mindfulness (MF-only) | Active comparator | Not described Receives: Behavioral: MF-only |
| 12-Week Sedentary Activities | Placebo comparator | Not described Receives: Behavioral: Sedentary activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhibition speed
Inhibition speed will be assessed by the response time (ms) during a child-friendly flanker task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Inhibition accuracy
Inhibition accuracy will be assessed by the response accuracy (percent) during a child-friendly flanker task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Updating speed
Updating speed will be assessed by the response time (ms) during a child-friendly n-back task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Updating accuracy
Updating accuracy will be assessed by the response accuracy (percent) during a child-friendly n-back task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Shifting speed
Shifting speed will be assessed by the response time (ms) during a child-friendly switching task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Shifting accuracy
Shifting accuracy will be assessed by the response accuracy (percent) during a child-friendly switching task.
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Secondary outcomes (6)
Aerobic capacity
Aerobic capacity will be assessed by the Progressive Aerobic Cardiovascular Endurance Run (PACER) test
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Upper body muscle endurance
Upper body muscle endurance will be assessed by the push-ups test
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Core body muscle endurance
Core body muscle endurance will be assessed by the curl-ups test
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Flexibility
Flexibility will be assessed by the back-saver sit and reach test
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Body composition
body composition will be assessed by the body mass index computed as weight (kg) / (height [m] * height [m])
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Dispositional mindfulness
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
Measured: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start14 Feb 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shih-Chun Kao, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258941
- Sponsor's protocol ID
- IRB-2024-1588
- Other IDs
- 1R21HD110656-01A1
- Status last verified
- Jun 2026
- First submitted
- 6 Feb 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting High-intensity Interval Training With Mindfulness for Enhancing Childhood Executive Function
- ClinicalTrials.gov ID
- NCT06258941
- Acronym / sponsor ID
- IRB-2024-1588
- Conditions
- Healthy Volunteers
- Keywords
- Executive function, Mindfulness, Interval exercise, Children, Fitness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
- Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
- Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
- Computerized tasks to assess EF
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 12-Week Mindful High-Intensity Interval Training (MF-HIIT) | Experimental | Behavioral: MF-HIIT |
| 12-Week High-Intensity Interval Training (HIIT-only) | Active comparator | Behavioral: HIIT-only |
| 12-Week Mindfulness (MF-only) | Active comparator | Behavioral: MF-only |
| 12-Week Sedentary Activities | Placebo comparator | Behavioral: Sedentary activity |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MF-HIITTwo 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. | Behavioural | 12-Week Mindful High-Intensity Interval Training (MF-HIIT) |
| HIIT-onlyTwo 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. | Behavioural | 12-Week High-Intensity Interval Training (HIIT-only) |
| MF-onlyTwo 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. | Behavioural | 12-Week Mindfulness (MF-only) |
| Sedentary activityTwo 10-min sedentary sessions every school day during the 12-week intervention period. One session in the morning and one session in the afternoon. | Behavioural | 12-Week Sedentary Activities |
Primary outcome
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.
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.
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.
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.
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.
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MF-HIIT, HIIT-only and MF-only in people with Healthy Volunteers, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-Chun (Alvin) Kao, PhD (765-496-2213, kao28@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhibition speed (time frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.