Status:
COMPLETED
Food-Body-Mind Intervention
Lead Sponsor:
Michigan State University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Children's Mental, Emotional, Behavioral, and Physical Health
Eligibility:
All Genders
3-5 years
Phase:
PHASE1
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 presc...
Detailed Description
Mental, emotional, and behavioral (MEB) disorders begin in early childhood, with one in six US preschoolers aged 3-5 years diagnosed with a MEB disorder. Children from low income and economically marg...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT05964218
Start Date
December 3 2023
End Date
July 31 2024
Last Update
September 19 2024
Active Locations (1)
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1
Community Action Agency
Jackson, Michigan, United States, 49203