Food-Body-Mind Intervention (16 Weeks)

Michigan State University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Mental Health Wellness; Obesity, Childhood; Emotional Problem; Behavioral Problem of Child; Social Skills

Treatments: Behavioral: Food-Body-Mind

Study type: Interventional

Funder types: Other

Identifiers

NCT06597474

STUDY00009256-MOD00007491

Details and patient eligibility

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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800 participants in 2 patient groups

Food-Body-Mind intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Food-Body-Mind

Usual care control

No Intervention group

Description:

Like those in the intervention group, preschoolers assigned to the control group will receive usual Head Start activities during the intervention period. After the 12-month follow-up data collection from both intervention and control participants in each year, each control family will receive all intervention supplies including the "Tasty Healthy Cookbook," "MyPlate" plates, and a breathing ball, as well as the program manual on how to use the intervention supplies. These intervention supplies will be distributed to control families at the end of in-person data collection appointments. Moreover, a virtual caregiver meeting on mindful eating, movement, and parenting will be provided to all caregivers who are interested.