Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families
Jiying Ling, T. Kao, Lorraine B. Robbins, Charis L Wahman, Jean M. Kerver, Kenneth Resnicow, Nanhua Zhang, H. Lalonde, Yingcen Xie, J. Baumgartner
Contemporary Clinical Trials November 1, 2025 DOI: 10.1016/j.cct.2025.108146 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Cluster randomized controlled trial Peer reviewed |
|---|---|
| Sample size | 400 |
| Population | Caregiver-preschooler dyads from racially/ethnically diverse, low-income, urban, and rural areas in the U.S. |
| Interventions | movement and parenting behaviors |
| Duration | 16-week intervention, with follow-up to 12 months (Month 16) |
| Topics | Meditation |
| Keywords | Education |
| Registration | NCT06597474 |
| Key findings | The trial is designed to test whether a 16-week mindfulness-based Food-Body-Mind intervention improves preschoolers' behavioral, mental, emotional, and anthropometric health and caregivers' mental and cardiometabolic health, with the primary outcome being problem behaviors. It will also examine potential mediators including caregiver mindfulness, physical activity, fruit and vegetable intake, caregiver-preschooler relationship, coping, home environment, and household food insecurity. |
Abstract
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 2
- The benefits of being present: Mindfulness and its role in psychological well-being. Journal of Personality and Social Psychology 2003
- A Mindfulness-Based Lifestyle Intervention Among Economically Marginalized Caregiver-Preschooler Dyads: Feasibility, Acceptability, and Satisfaction. School Mental Health 2025