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NCT06597474 · ClinicalTrials.gov registry record · Phase 2
Food-Body-Mind Intervention (16 Weeks)
A Phase 2 study of Obesity, Childhood and Mental Health Wellness, sponsored by Michigan State University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 800
- Enrollment target
- 1
- Study location
NCT06597474: Recruiting Phase 2 study of Obesity, Childhood and Mental Health Wellness, sponsored by Michigan State University.
NCT06597474 is a Phase 2 study of Obesity, Childhood and Mental Health Wellness that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 800 participants, above the 329-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (143% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597474, a Phase 2 study of Obesity, Childhood and Mental Health Wellness, is actively recruiting participants, sponsored by Michigan State University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 800 participants
- Enrollment target
- 1
- Study location
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. Preschoolers' problem behaviors rated by teachers will be the primary outcome, and problem behaviors rated by caregivers will be the secondary outcome.
Conditions Studied
Interventions
- BEHAVIORAL Food-Body-Mind
Study Locations (1)
Michigan
- Community Action Agency - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 800 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2028-07-31 |
| Phase | Phase 2 |
What NCT06597474 shows while recruiting
NCT06597474 is an interventional study that assigns participants to a tested intervention. The registered 800 participants enrollment target is mid-sized for trials with a published cap, above the 329-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (143% higher).
The record links to 5 conditions, with Obesity, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Food-Body-Mind is the first listed.
NCT06597474 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06597474 about?
NCT06597474 is a clinical study titled "Food-Body-Mind Intervention (16 Weeks)". 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 NCT06597474?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 800 participants. The study started on 2024-08-14. Estimated completion is 2028-07-31.
What conditions does trial NCT06597474 study?
This clinical trial studies the following conditions: Obesity, Childhood, Mental Health Wellness, Social Skills, Emotional Problem, Behavioral Problem of Child.
What interventions are being tested in trial NCT06597474?
The interventions under investigation include: Food-Body-Mind (BEHAVIORAL).
Who is sponsoring clinical trial NCT06597474?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06597474 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06597474's enrollment target sits among peer trials
800 6th of 53 higher than 48 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood 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.
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