Classroom Break, Cognition, and Fitness in Elementary School Children

NCT06258941 | Recruiting Phase 1 DMC

• 1 other identifier: IRB-2024-1588
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

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. 1.Kaufman Brief Intelligence Test (KBIT) to assess intelligence quotient
2. 2.Fitnessgram test to assess aerobic capacity, muscle endurance, flexibility, and body mass index
3. 3.Child and Adolescent Mindfulness Measure (CAMM) questionnaire to assess dispositional mindfulness
4. 4.Computerized tasks to assess EF
5. 5.Parent-reported demographic and health information

Conditions

Healthy Volunteers

Keywords

Executive function; Mindfulness; Interval exercise; Children; Fitness

Outcome Measures

Primary Outcomes (6)

• Inhibition speed

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

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (6)

• Aerobic capacity

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

• Upper body muscle endurance

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

• Core body muscle endurance

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

• Flexibility

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

• Body composition

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

Study Arms (4)

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

Interventions

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.

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

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.

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

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.

12-Week Mindfulness (MF-only)

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.

12-Week Sedentary Activities

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Purdue University: lead

Study Sites (1)

Pioneer Elementary School

Royal Center, Indiana, 46978, United States

RECRUITING

Central Study Contacts

Shih-Chun (Alvin) Kao, PhD

CONTACT

765-496-2213; kao28@purdue.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

US (1)