Recruiting
Phase 2
Phase 3

Food-Body-Mind Intervention

Sponsor:

Michigan State University

Code:

NCT06597474

Conditions

Mental Health Wellness

Emotional Problem

Behavioral Problem of Child

Social Skills

Obesity, Childhood

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

Interventions

Food-Body-Mind

Study Details

Brief summary:

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

Mental Health Wellness

Emotional Problem

Behavioral Problem of Child

Social Skills

Obesity, Childhood

Study ID

NCT06597474

Start date

Aug 14, 2024

Status verified date

Sep, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 5

Healthy Volunteers: Accepted

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 Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Food-Body-Mind intervention

Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the proposed 16-week Food-Body-Mind intervention includes: 1) a school-based mindfulness component delivered to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises); 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a school learning and home practice connection component to improve caregiver-preschooler relationships.

no intervention: Usual care control

Like those in the intervention group, preschoolers assigned to the control group will receive usual Head Start activities during the intervention period. After the 12-month follow-up data collection from both intervention and control participants in each year, each control family will receive all intervention supplies including the "Tasty Healthy Cookbook," "MyPlate" plates, and a breathing ball, as well as the program manual on how to use the intervention supplies. These intervention supplies will be distributed to control families at the end of in-person data collection appointments. Moreover, a virtual caregiver meeting on mindful eating, movement, and parenting will be provided to all caregivers who are interested.

Interventions

Food-Body-Mind

The Food-Body-Mind intervention includes 3 main components: 1) a school-based mindfulness component delivered by daycare teachers to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises) to reduce emotional eating and increase F/V intake and physical activity; 2) a home-based mindfulness component to increase caregivers' skills in practicing mindful eating, movement, and parenting behaviors at home to foster a more positive, mindful, and healthy home environment; and 3) a preschooler school learning and caregiver home practice connection component to improve caregiver-preschooler relationships.

Primary outcome measure

  • Preschoolers' problem behaviors [ Time Frame: Change from Month 0 (Time 1) to Month 4 (Time 2) ]

Central Contacts and Locations

Central contacts

Locations

Community Action Agency

Recruiting

Jackson, Michigan, United States, 49203

More Information

Sponsor

Michigan State University

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • Mindfulness
  • Mindful eating
  • Yoga
  • Deep breathing
  • Family
  • Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Michigan State University on 2025-09-26.