Clinical trial

Food-Body-Mind Intervention (16 Weeks)

Recruiting now · Phase 2, Phase 3 · 1 countries · Registry ID NCT06597474

Recruiting nowPhase 2, Phase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age3 Years to 5 Years
SexAll
Healthy volunteersAccepted
ConditionMental Health Wellness, Emotional Problem, Behavioral Problem of Child, Social Skills, Obesity, Childhood

Full registry criteria

Inclusion Criteria: 1. Parental consent and child (if the child is 5 years) verbal assent received 2. Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children 3. Caregivers are willing to use Facebook or the private program website for participation 4. Participants have at least weekly internet access using a smartphone, a tablet, or a computer Exclusion Criteria: 1. preschoolers who have a motor disability or impairment (e.g., cerebral palsy, spinal cord injury, lost or damaged limb, motor skills disorder, muscular dystrophy, spina bifida) preventing them from participating in any physical activity; 2. preschoolers who have a diagnosed medical condition (e.g., phenylketonuria, pediatric malabsorption syndrome, pollen food allergy syndrome) requiring a restrict diet and precluding them from any dietary changes particularly fruit/vegetable intake; and 3. preschoolers who have diagnosed disorders (e.g., autism spectrum disorder level 3) causing severe difficulty (e.g., nonverbal, cannot initiate social interaction) with communication and interaction with other people. There will be no exclusion criterion for primary adult caregivers, as the primary focus is preschoolers and caregivers serve as a support role.

Treatments and study arms

Food-Body-Mind

Behavioral

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.

Primary outcomes

Preschoolers' problem behaviorsChange from Month 0 (Time 1) to Month 4 (Time 2)

Problem behaviors will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Problem Behavior scale includes 42 items on 2 subscales: Externalizing Problems and Internalizing Problems. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of problem behaviors. Preschoolers' problem behaviors rated by teachers will be the primary outcome, and problem behaviors rated by caregivers will be the secondary outcome.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Community Action Agency🇺🇸 Jackson, Michigan, United States
Codi BenjaminContact