NCT06258941 Classroom Break, Cognition, and Fitness in Elementary School Children
| NCT ID | NCT06258941 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Purdue University |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 352 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 352 participants in total. It began in 2025-02-14 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06258941 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06258941 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06258941 currently recruiting?
Yes, NCT06258941 is actively recruiting participants. Contact the research team at kao28@purdue.edu for enrollment information.
Where is the NCT06258941 trial being conducted?
This trial is being conducted at Royal Center, United States.
Who is sponsoring the NCT06258941 clinical trial?
NCT06258941 is sponsored by Purdue University. The trial plans to enroll 352 participants.