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NCT05964218 · ClinicalTrials.gov registry record · Phase 1
Food-Body-Mind Intervention
A Phase 1 study, sponsored by Michigan State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT05964218: Completed Phase 1 study, sponsored by Michigan State University.
NCT05964218 is a Phase 1 study that has completed, run by Michigan State University. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05964218, a Phase 1 study, has completed, sponsored by Michigan State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.
Primary Outcome
Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors.
Interventions
- BEHAVIORAL Food-Body-Mind Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-12-03 |
| Est. Completion | 2024-07-31 |
| Phase | Phase 1 |
What the finished NCT05964218 record still lists
NCT05964218 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Food-Body-Mind Intervention is the first listed.
NCT05964218 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05964218 about?
NCT05964218 is a clinical study titled "Food-Body-Mind Intervention". This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to ...
What is the current status of trial NCT05964218?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2023-12-03. Estimated completion is 2024-07-31.
What interventions are being tested in trial NCT05964218?
The interventions under investigation include: Food-Body-Mind Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT05964218?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05964218's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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