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Food-Body-Mind Intervention (16 Weeks)

NCT06597474 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2025-09-26

No results posted yet for this study

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.

Conditions

  • Mental Health Wellness
  • Emotional Problem
  • Behavioral Problem of Child
  • Social Skills
  • Obesity, Childhood

Interventions

BEHAVIORAL

Food-Body-Mind

The 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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06597474 on ClinicalTrials.gov