Intervention for preschoolers' mental health and wellness
Food-Body-Mind Intervention: Promote Whole Child Health
This study is testing a 16-week program that combines mindfulness activities for preschoolers and their caregivers to see if it helps improve mental health for kids from low-income families.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Jackson, Michigan) |
| Trial ID | NCT06597474 on ClinicalTrials.gov |
What this trial studies
This intervention targets mental, emotional, and behavioral disorders in preschoolers aged 3-5 years from low-income backgrounds. It includes a 16-week program that combines school-based mindfulness practices, such as mindful eating and yoga, with home-based activities for caregivers to foster a supportive environment. The study aims to evaluate the effectiveness of this multi-component approach in improving health outcomes for both children and their caregivers. By addressing disparities in mental health, the intervention seeks to promote health equity among racially and ethnically diverse preschoolers.
Who should consider this trial
Good fit: Ideal candidates are preschoolers aged 3-5 years attending Head Start programs, along with their primary caregivers.
Not a fit: Children with motor disabilities or specific medical conditions that restrict dietary changes or physical activity may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and wellness in preschoolers, leading to better emotional and behavioral outcomes.
How similar studies have performed: Other studies have shown promise in using mindfulness and family-based interventions to improve mental health outcomes in children, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jackson, Michigan
- Community Action Agency — Jackson, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Jiying Ling, PhD
- Email: lingjiyi@msu.edu
- Phone: 5173538591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.