Actively Recruiting

Phase 2
Phase 3
Age: 3Years - 5Years
All Genders
Healthy Volunteers
ID06597474

Food-Body-Mind Intervention to Promote Whole Child Health in Preschoolers A 16-Week School- and Home-Based Mindfulness Program for Mental and Physical Health

Led by Michigan State University · Updated on 2025-09-26

800

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to address mental, emotional, and behavioral disorders in young children by evaluating a Food-Body-Mind intervention targeting racially and ethnically diverse preschoolers aged 3 to 5 years from low-income backgrounds attending Head Start programs in urban and rural areas. The study focuses on reducing health disparities and promoting whole child health by improving mental and physical health outcomes for both preschoolers and their caregivers. This 5-year cluster randomized controlled trial is guided by established stress and coping theories to support healthier generations in the US. The 16-week intervention includes three parts: a school-based mindfulness program delivered by daycare teachers to teach mindful eating and movement such as yoga and deep breathing; a home-based mindfulness component helping caregivers practice mindful eating, movement, and parenting to create a positive home environment; and a connection component to strengthen caregiver-preschooler relationships. Fifty daycare centers will be randomized to either receive the intervention or continue usual Head Start activities. Control group families will be offered intervention supplies and a virtual caregiver meeting after follow-up data collection. Participants will be involved over 16 months with assessments at baseline, immediately after the intervention, and at 12-month follow-up. Researchers will measure changes in preschoolers' problem behaviors, emotions, social skills, chronic stress, BMI, and body fat, as well as caregivers' physical and mental health including BMI, blood pressure, stress, anxiety, and depression. Data will be collected through behavioral assessments, physical measurements, and questionnaires to evaluate intervention effects and potential mediators. Safety and adherence will be monitored throughout the study period.

CONDITIONS

Brief Title

Food-Body-Mind Intervention (16 Weeks)

Who Can Participate

Age: 3Years - 5Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Parental consent and verbal assent from children aged 5 years
  • Children aged 3 to 5 years attending a Head Start program
  • Primary adult caregivers of these children
  • Caregivers willing to use Facebook or a private program website
  • Participants with weekly internet access via smartphone, tablet, or computer
Not Eligible

You will not qualify if you...

  • Preschoolers with motor disabilities preventing physical activity (e.g., cerebral palsy, spinal cord injury, muscular dystrophy)
  • Preschoolers with diagnosed medical conditions requiring restrictive diets affecting fruit or vegetable intake
  • Preschoolers with diagnosed disorders causing severe communication and social interaction difficulties (e.g., autism spectrum disorder level 3)
  • No exclusion criteria for primary adult caregivers

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 16 weeks

Participants engage in a 16-week school- and home-based mindfulness program including mindful eating, movement, and parenting practices to promote mental, emotional, behavioral, and physical health in preschoolers and their caregivers.

Weekly visits during the 16-week intervention

Follow-up

Duration - 12 months

Participants are monitored for longer-term effects on mental, emotional, behavioral, and physical health outcomes up to 12 months after the intervention ends.

1 visit at 12 months post-intervention

Trial Site Locations

Total: 1 location

1

Community Action Agency

Jackson, Michigan, United States, 49203

Actively Recruiting

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Research Team

J

Jiying Ling, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families.

Jiying Ling, Tsui-Sui Annie Kao, Lorraine B Robbins...

https://pubmed.ncbi.nlm.nih.gov/41265832