Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 3 to 5

Intervention for preschoolers' mental health and wellness

Official title: Food-Body-Mind Intervention: Promote Whole Child Health

Run by Michigan State University · NCT06597474 · Data updated 2026-11-12

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.

More Obesity, Childhood trials

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Ages3 Years to 5 Years
SexAll
Enrollment800 (estimated)
SponsorMichigan State University
Academic / other
Locations1 site (Jackson, Michigan)
StatusRecruiting
StartedAugust 14, 2024
Main results expectedMay 31, 2028
Study endsAugust 31, 2028
Registry record updatedOctober 5, 2026
Trial IDNCT06597474 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are preschoolers aged 3-5 years attending Head Start programs, along with their primary caregivers.

Probably not a fit

Children with motor disabilities or specific medical conditions that restrict dietary changes or physical activity may not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Community Action Agency
    Jackson, Michigan, United States
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.