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.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 3 Years to 5 Years |
| Sex | All |
| Enrollment | 800 (estimated) |
| Sponsor | Michigan State University Academic / other |
| Locations | 1 site (Jackson, Michigan) |
| Status | Recruiting |
| Started | August 14, 2024 |
| Main results expected | May 31, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT06597474 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
- Study coordinator: Jiying Ling, PhD
- Email: lingjiyi@msu.edu
- Phone: 5173538591
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Wise Interventions to Boost Pediatric Weight Control
This study tests whether adding two quick social-psychology activities (growth mindset and self-affirmation) to a family-based weight management program helps 10–15 year-olds with obesity achieve better BMI outcomes over 12 months.
-
Telecare psychosocial and cognitive program for kids with limb-girdle muscular dystrophy
A telecare-based group program is tested to see if it helps 7- to 17-year-olds with limb-girdle muscular dystrophy improve quality of life and social skills.
-
Dinosaur Child Program for 4- to 8-year-olds with conduct problems
This trial tests whether the Incredible Years Dinosaur Child Program helps 4- to 8-year-olds with conduct problems improve behavior, emotions, and social skills, compared with a waitlist control.
-
Effects of postpartum exercise on breastmilk composition
This study is testing how a single workout by new mothers affects the nutrients and antibodies in their breastmilk to see if it can help their babies grow healthier.
-
Vitamin D supplementation for obese children
This study is testing whether different doses of vitamin D can help obese kids and teens improve their insulin levels and body fat over six months.
-
Behavioral sleep intervention for preventing obesity in children
This study is testing whether helping children aged 6-11 from lower-income families improve their sleep with personal coaching or educational materials can prevent obesity.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.