Food-Body-Mind Intervention: Promote Whole Child Health
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Preschoolers' problem behaviors
研究概览
简要总结
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.
详细描述
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, emotional eating, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Investigators will blind data collectors, participants, statistician, and all co-Is in this study.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental consent and child (if the child is 5 years) verbal assent received
- •Participants understand and speak English
- •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
排除标准
- •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) causing difficulty with communication and interaction with other people. Investigators expect these three criteria will exclude very few preschoolers based on investigators' prior clinical trial experiences working with Head Start daycare centers.
- •There will be no exclusion criterion for primary adult caregivers, as the primary focus is preschoolers and caregivers serve as a support role.
结局指标
主要结局
Preschoolers' problem behaviors
时间窗: Month 0 (Time 1)
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.
次要结局
- Preschoolers' social skills(Month 0 (Time 1))
- Preschoolers' sadness(Month 0 (Time 1))
- Preschoolers' fear(Month 0 (Time 1))
- Preschoolers' anger(Month 0 (Time 1))
- Preschoolers' positive affect(Month 0 (Time 1) t)
- Dyads' BMI(Month 0)
- Dyads' percent body fat(Month 0)
- Preschoolers' chronic stress(Month 0 (Time 1))
- Dyads' physical activity(Month 0 (Time 1))
- Dyads' fruit/vegetable intake(Month 0 (Time 1))
- Caregivers' stress(Month 0 (Time 1))
- Caregivers' blood pressure(Month 0 (Time 1))
- Caregiver-preschooler relationship(Month 0 (Time 1))
- Caregiver mindfulness(Month 0 (Time 1))
- Caregiver coping(Month 0 (Time 1))
- Household food insecurity(Month 0 (Time 1))
- Home environment(Month 0 (Time 1))
- Caregivers' anxiety and depression(Month 0 (Time 1))
研究者
Jiying Ling
Associate Professor
Michigan State University