Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Purdue University

Code:

NCT06258941

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

Interventions

MF-HIIT

HIIT-only

MF-only

Sedentary activity

Study Details

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.

Conditions

Healthy Volunteers

Study ID

NCT06258941

Start date

Feb 14, 2025

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 12

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

352 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 12-Week Mindful High-Intensity Interval Training (MF-HIIT)

active comparator: 12-Week High-Intensity Interval Training (HIIT-only)

active comparator: 12-Week Mindfulness (MF-only)

placebo comparator: 12-Week Sedentary Activities

Interventions

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.

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.

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.

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Shih-Chun (Alvin) Kao, PhD

765-496-2213kao28@purdue.edu

Locations

Pioneer Elementary School

Recruiting

Royal Center, Indiana, United States, 46978

Contacts

Pat Principal Quillen

574-643-2255quillenp@pioneer.k12.in.us

More Information

Sponsor

Purdue University

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Executive function
  • Mindfulness
  • Interval exercise
  • Children
  • Fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Purdue University on 2026-06-25.