NCT06597474 Food-Body-Mind Intervention (16 Weeks)
| NCT ID | NCT06597474 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Michigan State University |
| Condition | Mental Health Wellness |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 800 participants in total. It began in 2024-08-14 with a primary completion date of 2028-05-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Parental consent and child (if the child is 5 years) verbal assent received 2. Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children 3. Caregivers are willing to use Facebook or the private program website for participation 4. Participants have at least weekly internet access using a smartphone, a tablet, or a computer Exclusion Criteria: 1. preschoolers who have a motor disability or impairment (e.g., cerebral palsy, spinal cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina bifida) preventing them from participating in any physical activity; 2. preschoolers who have a diagnosed medical condition (e.g., phenylketonuria, pediatric malabsorption syndrome, pollen food allergy syndrome) requiring a restrict diet and precluding them from any dietary changes particularly fruit/vegetable intake; and 3. preschoolers who have diagnosed disorders (e.g., autism spectrum disorder level 3) causing severe difficulty (e.g., nonverbal, cannot initiate social interaction) with communication and interaction with other people. There will be no exclusion criterion for primary adult caregivers, as the primary focus is preschoolers and caregivers serve as a support role.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06597474 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 5 Years, studying Mental Health Wellness. 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 NCT06597474 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06597474 currently recruiting?
Yes, NCT06597474 is actively recruiting participants. Contact the research team at lingjiyi@msu.edu for enrollment information.
Where is the NCT06597474 trial being conducted?
This trial is being conducted at Jackson, United States.
Who is sponsoring the NCT06597474 clinical trial?
NCT06597474 is sponsored by Michigan State University. The trial plans to enroll 800 participants.