Clinical trial NCT06597474: Food-Body-Mind Intervention (16 Weeks)
Official title: Food-Body-Mind Intervention: Promote Whole Child Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Mental Health Wellness
Emotional Problem
Behavioral Problem of Child
Social Skills
Obesity, Childhood
Keywords: Mindfulness
Mindful eating
Yoga
Deep breathing
Family
Prevention
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 800
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-group cluster RCT
Primary purpose: PREVENTION

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 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 (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 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 (n=25: 8 urban and 17 rural daycare centers) or usual care control group (n=25: 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 F/U) 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 F/U) compared to control; and 3) explore the potential mediators (caregiver mindfulness, physical activity, F/V 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 F/U). Results from this study will improve the evidence base of complementary and integrative health approaches that can be delivered in geographically diverse daycare settings.

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: Change from Month 0 (Time 1) to Month 4 (Time 2)
Secondary outcomes:
measure: Preschoolers' problem behaviors
timeFrame: Change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' social skills
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' sadness
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' fear
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' anger
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' positive affect
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Dyads' BMI
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Dyads' percent body fat
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Preschoolers' chronic stress
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Dyads' physical activity
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Dyads' fruit/vegetable intake
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregivers' blood pressure
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregiver-preschooler relationship
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregiver mindfulness
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregiver coping
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Household food insecurity
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Home environment
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregivers' anxiety
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregivers' stress
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
measure: Caregivers' depression
timeFrame: Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
Other outcomes:
Locations:
city: Jackson
country: United States
facility: Community Action Agency
state: Michigan
Study officials:
References: