Food-Body-Mind Intervention (16 Weeks)

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-5
SponsorMichigan State University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Parental consent and child (if the child is 5 years) verbal assent received

Children are 3-5 years old attending a Head Start program and caregivers are the primary adult caregivers for the children

Caregivers are willing to use Facebook or the private program website for participation

Participants have at least weekly internet access using a smartphone, a tablet, or a computer

Disqualifiers

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;

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

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Food-Body-Mind interventionExperimental treatment 1 intervention
Group B: Usual care controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Preschoolers' problem behaviors

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.

Time frame
Change from Month 0 (Time 1) to Month 4 (Time 2)

Secondary outcomes

1

Preschoolers' problem behaviors

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.

Time frame
Change from Month 4 (Time 2) to Month 16 (Time 3)
2

Preschoolers' social skills

Social skills will be assessed by the Preschool and Kindergarten Behavior Scales-Second Edition (PKBS-2). The Social Skills scale includes 34 items on 3 subscales: Social Cooperation, Social Interaction, and Social Independence. Total standard scores (M=100, SD=15) will be calculated, with a higher score indicating a higher level of social skills.

Time frame
Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
3

Preschoolers' sadness

Sadness will be assessed by the 7-item National Institutes of Health (NIH) Toolbox Sadness Parent Report Fixed Form. Response choices for the 3-Likert scale include: never or not true, sometimes or somewhat true, and often or very true. A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10). A higher T-score indicates a higher level of sadness reported by parents/caregivers.

Time frame
Change from Month 0 (Time 1) to Month 4 (Time 2), and change from Month 4 (Time 2) to Month 16 (Time 3)
4

Preschoolers' fear

Fear will be assessed by the 6-item, 3-Likert (never or not true, sometimes or somewhat true, often or very true) NIH Toolbox Fear-Over Anxious Parent Report Fixed Form. A total raw score was calculated and then transformed to the uncorrected T-scores (M=50, SD=10). A high T-score indicates a higher level of fear.

Time frame
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

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