Clinical Trial

Food-Body-Mind Intervention (16 Weeks)

Recruiting Phase 2/3
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-13.
Trial Details
NCT Number NCT06597474
Lead Sponsor Michigan State University
Conditions Mental Health Wellness, Emotional Problem, Behavioral Problem of Child, Social Skills, Obesity, Childhood
Enrollment 800 participants
Start Date 2024-08-14
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-26