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NCT05964218

Food-Body-Mind Intervention

Completed Phase 1 Last updated 19 September 2024
What this trial tests

Phase 1 trial testing Food-Body-Mind Intervention in Children's Mental, Emotional, Behavioral, and Physical Health in 37 participants. Completed in 31 July 2024.

Timeline
3 December 2023
Primary endpoint
30 April 2024
31 July 2024

Quick facts

Lead sponsorMichigan State University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment37
Start date3 December 2023
Primary completion30 April 2024
Estimated completion31 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Michigan State University

Who can join

Adults 3 to 5, any sex, with Children's Mental, Emotional, Behavioral, and Physical Health. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A Mindfulness-Based Lifestyle Intervention Among Economically Marginalized Caregiver-Preschooler Dyads: Feasibility, Acceptability, and Satisfaction.
    Ling J, Ashley A, Zahry N, Kao TA, et al · · 2025 · cited 1× · PMID 40656841 · DOI 10.1007/s12310-025-09767-w

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