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RecruitingAccepts healthy volunteersPhase 2/Phase 3

Food-Body-Mind Intervention (16 Weeks)

Michigan State University · NCT06597474

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 3–5 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2, Phase 3
Target enrollment
800
US sites recruiting
1
Study start
August 14, 2024
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Food-Body-Mind

Conditions: Mental Health Wellness; Emotional Problem; Behavioral Problem of Child; Social Skills; Obesity, Childhood

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Parental consent and child (if the child is 5 years) verbal assent received
  • Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children
  • Caregivers are willing to use Facebook or the private program website for participation
  • Participants have at least weekly internet access using a smartphone, a tablet, or a computer

Exclusion Criteria

  • 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;
  • 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
  • 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.

Recruiting US locations

  • Community Action Agency

    Jackson, MI 49203

    Site contact: Codi Benjamin

Study contacts (from the official record)

  • Jiying Ling, PhD · 5173538591 · lingjiyi@msu.edu
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Food-Body-Mind Intervention (16 Weeks) (NCT06597474) | Bored Studies