RightFit
RecruitingPhase 2 / Phase 3

Food-Body-Mind Intervention (16 Weeks)

Food-Body-Mind Intervention: Promote Whole Child Health

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
3 Years to 5 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a 16-week Food-Body-Mind program to support mental health in young children. It is for children ages 3–5 in Head Start and their main adult caregivers, focusing on low-income families from diverse racial and ethnic backgrounds in cities and rural areas.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A parent must give permission. Children who are 5 must also say they agree to take part.
  • Children must be ages 3–5 and attend Head Start.
  • Adults must be the children's main caregivers.
  • Caregivers must be willing to use Facebook or the program's private website.
  • Participants must have internet access at least once a week on a smartphone, tablet, or computer.

Who can't join

  • Children cannot take part if a movement disability prevents them from doing any physical activity.
  • Children cannot take part if a diagnosed health condition requires a strict diet and prevents any diet changes, especially changes in fruits and vegetables.
  • Children cannot take part if a diagnosed condition causes severe trouble communicating and interacting with others, such as being unable to speak or start social contact.
  • There are no exclusion rules for main adult caregivers, who help support the children.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

MI