Clinical Trials Directory

Trials / Completed

CompletedNCT05964218

Food-Body-Mind Intervention

Food-Body-Mind Intervention: Promote Whole Child Health

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
37 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
3 Years – 5 Years
Healthy volunteers
Accepted

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.

Detailed description

Mental, emotional, and behavioral (MEB) disorders begin in early childhood, with one in six US preschoolers aged 3-5 years diagnosed with a MEB disorder. Children from low income and economically marginalized (LIEM) backgrounds have a higher risk of being diagnosed with MEB disorders than those from higher income families. To address the mental and physical health disparities based on socioeconomic status, ethnicity/race, and urban/rural residency, the proposed study will target Head Start racially/ethnically diverse preschoolers from LIEM backgrounds in both urban and rural areas. Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the pilot 5-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. The three aims are: Aim 1: Finalize forms, procedures, community partners, protocols, and train research staff for trial implementation. Aim 2: Implement study in 1 urban \& 1 rural daycares; complete enrollment of 12 dyads, collect baseline data, begin intervention in both daycares for 5 weeks; evaluate recruitment, data collection/management, and intervention fidelity. Aim 3: Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFood-Body-Mind InterventionThe 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.

Timeline

Start date
2023-12-03
Primary completion
2024-04-30
Completion
2024-07-31
First posted
2023-07-27
Last updated
2024-09-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05964218. Inclusion in this directory is not an endorsement.