Clinical trial NCT05964218: Food-Body-Mind Intervention
Official title: Food-Body-Mind Intervention: Promote Whole Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Children's Mental, Emotional, Behavioral, and Physical Health
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2023-07-27
Enrollment: 37
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One-group pilot study with baseline assessment (T1) only.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Preschoolers' problem behaviors
timeFrame: Month 0 (Time 1)
Secondary outcomes:
measure: Preschoolers' social skills
timeFrame: Month 0 (Time 1)
measure: Preschoolers' sadness
timeFrame: Month 0 (Time 1)
measure: Preschoolers' fear
timeFrame: Month 0 (Time 1)
measure: Preschoolers' anger
timeFrame: Month 0 (Time 1)
measure: Preschoolers' positive affect
timeFrame: Month 0 (Time 1) t
measure: Dyads' BMI
timeFrame: Month 0
measure: Dyads' percent body fat
timeFrame: Month 0
measure: Preschoolers' chronic stress
timeFrame: Month 0 (Time 1)
measure: Dyads' physical activity
timeFrame: Month 0 (Time 1)
measure: Dyads' fruit/vegetable intake
timeFrame: Month 0 (Time 1)
measure: Caregivers' blood pressure
timeFrame: Month 0 (Time 1)
measure: Caregiver-preschooler relationship
timeFrame: Month 0 (Time 1)
measure: Caregiver mindfulness
timeFrame: Month 0 (Time 1)
measure: Caregiver coping
timeFrame: Month 0 (Time 1)
measure: Household food insecurity
timeFrame: Month 0 (Time 1)
measure: Home environment
timeFrame: Month 0 (Time 1)
measure: Caregivers' anxiety and depression
timeFrame: Month 0 (Time 1)
measure: Caregivers' stress
timeFrame: Month 0 (Time 1)
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Community Action Agency
state: Michigan
Study officials:
References: