Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families

Socioeconomic, racial/ethnic, and urban/rural disparities in mental, emotional, behavioral, and physical health are evident among U.S. preschoolers. To reduce these disparities, we plan to test our Food-Body-Mind intervention with preschoolers from racially/ethnically diverse, low-income, urban, and rural areas. The aims of the study are to determine the effects of the intervention on improving preschoolers' behavioral (primary outcome is problem behaviors), mental, emotional, and anthropometric health outcomes, as well as their caregivers' mental and cardiometabolic health from baseline to post-intervention to 12-month (Month 16) follow-up. Additionally, we will explore potential mediators (e.g., caregiver mindfulness, physical activity [PA], fruit/vegetable [F/V] intake, caregiver-preschooler relationship, caregiver coping, home environment, and household food insecurity) of the intervention effects. This cluster randomized controlled trial will include 50 daycare centers assigned to intervention (25 centers) or control (25 centers) conditions using a covariate-constrained randomization approach. A total of 400 (on average 8 per center) caregiver-preschooler dyads will be enrolled from 2024 to 2027. The 16-week mindfulness-based intervention includes three components: 1) school-based mindful eating and movement learning for preschoolers; 2) a home-based caregiver skill training on practicing mindful eating, movement, and parenting behaviors at home; and 3) a bridge between school and home in mindfulness learning and practice. Linear mixed-effect models will be used to determine the intervention effects, and structural equation modeling will be performed to examine potential mediators. Trial registration number: NCT06597474.