RecruitingPhase 2/3

Food-Body-Mind Intervention (16 Weeks)

United States800 participantsStarted 2024-08-14

Plain-language 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.

Who can participate

Age range3 Years – 5 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

Preschoolers' problem behaviors

Timeframe: Change from Month 0 (Time 1) to Month 4 (Time 2)

Trial details

NCT IDNCT06597474

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-31

Contact for this trial

Jiying Ling, PhD

5173538591 lingjiyi@msu.edu

View on ClinicalTrials.gov More Mental Health Wellness trials