Actively Recruiting

Phase 2
Phase 3
Age: 3Years - 5Years
All Genders
Healthy Volunteers
NCT06597474

Food-Body-Mind Intervention (16 Weeks)

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

800

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This novel, timely, and theory-driven Food-Body-Mind intervention addresses the national emergency of mental health crises in early childhood. By targeting Head Start racially/ethnically diverse preschoolers from low-income backgrounds in both urban and rural areas, this intervention is expected to contribute toward reducing health disparities and promoting health equity, a major priority of the NIH and Healthy People 2030. If effective, it can be scalable to Head Start programs across urban and rural settings nationally with long-term sustainability benefits.

CONDITIONS

Official 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 child verbal assent (if the child is 5 years old) are obtained
  • Children aged 3 to 5 years attending a Head Start program
  • Caregivers are the primary adult caregivers for the children
  • Caregivers willing to use Facebook or a private program website for participation
  • Participants have at least weekly internet access using a smartphone, tablet, or computer
Not Eligible

You will not qualify if you...

  • Preschoolers with motor disabilities or impairments preventing participation in physical activity (e.g., cerebral palsy, spinal cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina bifida)
  • Preschoolers with diagnosed medical conditions requiring a restricted diet that prevents dietary changes, especially in fruit and vegetable intake (e.g., phenylketonuria, pediatric malabsorption syndrome, pollen food allergy syndrome)
  • Preschoolers with diagnosed disorders causing severe difficulty in communication and social interaction (e.g., autism spectrum disorder level 3, nonverbal, inability to initiate social interaction)
  • No exclusion criteria apply to primary adult caregivers since their role is supportive

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

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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