Food-Body-Mind Intervention (16 Weeks)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-5
SponsorMichigan State University

About this trial

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

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Food-Body-Mind

Treatment groups

800 Participants
are divided into 2 treatment groups

Sponsors and collaborators