16-Week Food-Body-Mind Program to Improve Mental, Emotional, and Physical Health in Preschoolers and Their Caregivers
Led by Michigan State University · Updated on 2025-09-26
800
Participants Needed
1
Research Sites
N/A
Total Duration
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)
Research Team
J
Jiying Ling, PhD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Food‑Body‑Mind behavioral program
Usual care control
What it is
A behavioral program delivered in preschool and home settings combining mindful eating, movement, and caregiver‑child relationship practices
The standard or no‑intervention condition reflecting usual care without the added mindful‑eating and movement components
Role in the trial
Investigational behavioral intervention delivered by teachers and caregivers
Control arm providing usual care with no additional intervention activities
Primary use
To promote self‑regulation, healthy eating, physical activity, social‑emotional development, and caregiver‑child interaction among preschoolers
Represents usual care for Head Start preschoolers without added behavioral support
How it is given or performed
Delivered through school‑based mindfulness activities by teachers plus home‑based caregiver practice support
No additional program sessions offered beyond usual classroom or home routines
Evidence status
Efficacy under investigation; outcomes include behavior, social‑emotional skills, BMI and caregiver measures through month 4 and month 16
Serves as comparator; no intervention effects expected beyond usual development
Important risks
None identified in registry
None identified beyond typical preschool routines
Important limitations
Generalizability may be limited to Head Start settings with family internet access; relies on caregiver engagement and technology availability
Control does not include intervention support, preventing assessment of active components in community settings without infrastructure
Patient impact
Impact not yet established; outcomes under study include behavior, BMI, family environment through month 16
No additional impact expected beyond natural development
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 3Years - 5Years
All Genders
Healthy Volunteers
Eligibility Criteria
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
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
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
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...