Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964218
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2023-07-18
Brief Title:
Food-Body-Mind Intervention
Sponsor:
Michigan State University
Organization:
Michigan State University
Study Overview
Official Title:
Food-Body-Mind Intervention Promote Whole Child Health
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raciallyethnically 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 ethnicityrace and urbanrural residency the proposed study will target Head Start raciallyethnically 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 eg 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 collectionmanagement and intervention fidelity
Aim 3 Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3
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 collectionmanagement and intervention fidelity
Aim 3 Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG3AT012521-01 | NIH | None | httpsreporternihgovquickSearch1UG3AT012521-01 |