Classroom Break, Cognition, and Fitness in Elementary School Children

Part of paid clinical trials in Royal Center, Indiana.

Sponsor
Purdue University
Study ID
NCT06258941
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
8 Years - 12 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
Apr 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

Primary Outcome Measure

Inhibition speed [ Time Frame: At the baseline (1-2 weeks) before intervention starts and after (1-2 weeks) the intervention ends ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pioneer Elementary SchoolRoyal CenterIndiana46978
Pat Principal Quillen
[email protected]
574-643-2255

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Pioneer Elementary School· Royal Center, IN

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