Life sciences · Phase 2/3 Trial
ClinicalTrials.gov · October 5, 2026
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Phase 2/3 Trial.
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Registry record from ClinicalTrials.gov (NCT06597474). This is a study registration, not published results. Lead sponsor: Michigan State University. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 800 participants (ESTIMATED). Conditions: Mental Health Wellness, Emotional Problem, Behavioral Problem of Child, Social Skills, Obesity, Childhood. Interventions: BEHAVIORAL: Food-Body-Mind. Primary outcome measures: Preschoolers' problem behaviors , Change from Month 0 (Time 1) to Month 4 (Time 2). 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.