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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Food-Body-Mind Intervention (16 Weeks)

Food-Body-Mind Intervention: Promote Whole Child Health

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

Food-Body-Mind

The Food-Body-Mind intervention includes 3 main components: 1) a school-based mindfulness component delivered by daycare teachers to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises) to reduce emotional eating and increase F/V intake and physical activity; 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a preschooler school learning and caregiver home practice connection component to improve caregiver-preschooler relationships.

Locations (1)

Community Action Agency
Jackson, Michigan, United States