NCT06597474RecruitingPhase 2/3
Food-Body-Mind Intervention (16 Weeks)
Food-Body-Mind Intervention: Promote Whole Child Health
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- Aug 2024
- Primary completion date
- May 2028
- Lead sponsor
- Michigan State University
- Diseases
- Obesity
- NCT number
- NCT06597474
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 800
- From Aug 2024 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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
- 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.
Who the study is looking for
- Parental consent and child (if the child is 5 years) verbal assent received
- Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children
- Caregivers are willing to use Facebook or the private program website for participation
- Participants have at least weekly internet access using a smartphone, a tablet, or a computer
Age in the registry: 3 years to 5 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Community Action Agency Coordinator of this site? Confirm its status | Jackson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.