Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597474
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-11
Brief Title:
Food-Body-Mind Intervention 16 Weeks
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Food-Body-Mind Intervention Promote Whole Child Health
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 proposed 16-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 purpose of this 5-year cluster randomized controlled trial is to evaluate the effects of the 16-week school- and home-based multi-component Food-Body-Mind intervention on improving both preschoolers and caregivers MEB and physical health The long-term goal is to achieve optimal whole child health in early childhood to foster a healthier generation in the US Fifty Head Start daycare centers will be randomized into the intervention n25 8 urban and 17 rural daycare centers or usual care control group n25 8 urban and 17 rural daycare centers Five caregiver-preschooler dyads will be recruited from each daycare classroom total 400 dyads from 80 daycare classrooms 200 urban dyads and 200 rural dyads Analyses will be based on the intention-to-treat principle The three aims are to 1 determine effects of the intervention on improving preschoolers mental chronic stress by hair cortisol emotional sadness fear anger positive affect behavioral problem behaviors social skills and physical health BMI z-score body fat from baseline 0 month to 4 months immediate post-intervention and to 16 months post-baseline 12-month FU when compared to control group in geographically diverse urban and rural Head Start daycare sites 2 examine intervention effects on improving caregivers physical BMI body fat blood pressure and mental stress anxiety depression health from 0 to 4 months and to 16 months 12-month FU compared to control and 3 explore the potential mediators caregiver mindfulness physical activity FV intake caregiver-preschooler relationship and caregiver coping of intervention effects on preschoolers MEB and physical health and caregivers physical and mental health from 0 to 4 months and to 16 months 12-month FU Results from this study will improve the evidence base of complementary and integrative health approaches that can be delivered in geographically diverse daycare settings
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None