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NCT06258941 · ClinicalTrials.gov registry record · Phase 1
Classroom Break, Cognition, and Fitness in Elementary School Children
A Phase 1 study of Healthy Volunteers, sponsored by Purdue University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 352
- Enrollment target
- 1
- Study location
NCT06258941 is a Phase 1 study of Healthy Volunteers that is actively recruiting participants, run by Purdue University. The registered enrollment target is 352 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (27% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06258941, a Phase 1 study of Healthy Volunteers, is actively recruiting participants, sponsored by Purdue University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 352 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BEHAVIORAL MF-HIIT
- BEHAVIORAL MF-only
- BEHAVIORAL HIIT-only
- BEHAVIORAL Sedentary activity
Study Locations (1)
Indiana
- Pioneer Elementary School - Royal Center
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 352 participants |
| Start Date | 2025-02-14 |
| Est. Completion | 2026-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06258941
The ClinicalTrials.gov registry entry for NCT06258941 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 352 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (27% lower). The listed sponsor is Purdue University, which has 141 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which MF-HIIT is the first listed.
NCT06258941 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT06258941 about?
NCT06258941 is a clinical study titled "Classroom Break, Cognition, and Fitness in Elementary School Children". 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...
What is the current status of trial NCT06258941?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 352 participants. The study started on 2025-02-14. Estimated completion is 2026-05-31.
What conditions does trial NCT06258941 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT06258941?
The interventions under investigation include: MF-HIIT (BEHAVIORAL), MF-only (BEHAVIORAL), HIIT-only (BEHAVIORAL), Sedentary activity (BEHAVIORAL).
Who is sponsoring clinical trial NCT06258941?
This trial is sponsored by Purdue University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06258941 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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