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Food-Body-Mind Intervention (16 Weeks)

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Primary completion moved earlier from Jul 31, 2028 to May 31, 2028
    • Study completion pushed from Jul 31, 2028 to Aug 31, 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 20 of 20 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06597474
Lead Sponsor Michigan State University
Conditions
(from sponsor)		 Mental Health Wellness, Emotional Problem, Behavioral Problem of Child, Social Skills, Obesity, Childhood
Related terms Pediatric Obesity, Social Skills
Enrollment 800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov