Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT05964218
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.
Detailed Description:
Mental, emotional, and behavioral (MEB) disorders begin in early childhood, with one in six US preschoolers aged 3-5 years diagnosed with a MEB disorder. Children from low income and economically marginalized (LIEM) backgrounds have a higher risk of being diagnosed with MEB disorders than those from higher income families. To address the mental and physical health disparities based on socioeconomic status, ethnicity/race, and urban/rural residency, the proposed study will target Head Start racially/ethnically diverse preschoolers from LIEM backgrounds in both urban and rural areas. Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the pilot 5-week Food-Body-Mind intervention includes: 1) a school-based mindfulness component delivered to equip preschoolers with knowledge and skills in mindful eating and movement (e.g., yoga, deep breathing exercises); 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 school learning and home practice connection component to improve caregiver-preschooler relationships. The three aims are:
Aim 1: Finalize forms, procedures, community partners, protocols, and train research staff for trial implementation.
Aim 2: Implement study in 1 urban \& 1 rural daycares; complete enrollment of 12 dyads, collect baseline data, begin intervention in both daycares for 5 weeks; evaluate recruitment, data collection/management, and intervention fidelity.
Aim 3: Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3.
Study:
NCT05964218
Study Brief:
Protocol Section:
NCT05964218