Food-Body-Mind Intervention (16 Weeks)

Part of paid clinical trials in Jackson, Michigan.

Sponsor
Michigan State University
Study ID
NCT06597474
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Behavioral Problem of Child
  • Emotional Problem
  • Mental Health Wellness
  • Obesity, Childhood
  • Social Skills

Eligibility Criteria

Sex
ALL
Age
3 Years - 5 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Aug 14, 2024
Status verified
Sep 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Community Action AgencyJacksonMichigan49203
Codi Benjamin

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By research site
Community Action Agency· Jackson, MI

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