Classroom Break, Cognition, and Fitness in Elementary School Children

NCT ID: NCT06258941

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-14
• Study Completion Date: 2026-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

MF-HIIT

Intervention Type: 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.

12-Week High-Intensity Interval Training (HIIT-only)

Group Type: ACTIVE_COMPARATOR

HIIT-only

Intervention Type: 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.

12-Week Mindfulness (MF-only)

Group Type: ACTIVE_COMPARATOR

MF-only

Intervention Type: 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.

12-Week Sedentary Activities

Group Type: PLACEBO_COMPARATOR

Sedentary activity

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Purdue University

OTHER

Sponsor Role: lead

Responsible Party

Shih-Chun Kao

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pioneer Elementary School

Royal Center, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shih-Chun (Alvin) Kao, PhD

Role: CONTACT

kao28@purdue.edu

765-496-2213

Facility Contacts

Pat Principal Quillen

Role: primary

quillenp@pioneer.k12.in.us

574-643-2255

Other Identifiers

IRB-2024-1588

Identifier Type: -

Identifier Source: org_study_id