Food-Body-Mind Intervention (16 Weeks)

NCT06597474 | Recruiting Phase 2 DMC

• 1 other identifier: STUDY00009256-MOD00007491
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Preschoolers' problem behaviors

  Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors. Preschoolers' problem behaviors rated by teachers will be the primary outcome, and problem behaviors rated by caregivers will be the secondary outcome.

  Change from Month 0 (Time 1) to Month 4 (Time 2)

Secondary Outcomes (20)

• Preschoolers' problem behaviors

  Change from Month 4 (Time 2) to Month 16 (Time 3)

• Preschoolers' social skills

  Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)

• Preschoolers' sadness

  Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)

• Preschoolers' fear

  Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)

• Preschoolers' anger

  Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)

Study Arms (2)

Food-Body-Mind intervention

EXPERIMENTAL

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.

Behavioral: Food-Body-Mind

Usual care control

NO INTERVENTION

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 BEHAVIORAL

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.

Food-Body-Mind intervention

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (1)

Community Action Agency

Jackson, Michigan, 49203, United States

RECRUITING

Related Publications (1)

• Ling J, Kao TA, Robbins LB, Wahman CL, Kerver JM, Resnicow K, Zhang N, Lalonde H, Xie Y, Baumgartner J. Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families. Contemp Clin Trials. 2026 Jan;160:108146. doi: 10.1016/j.cct.2025.108146. Epub 2025 Nov 19.

  PMID: 41265832 DERIVED

MeSH Terms

Conditions

Social Skills; Pediatric Obesity

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jiying Ling, PhD

CONTACT

5173538591; lingjiyi@msu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two-group cluster RCT

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)