Food-Body-Mind Intervention: Promote Whole Child Health
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 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 pilot 5-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 three aims are:
Aim 1: Finalize forms, procedures, community partners, protocols, and train research staff for trial implementation.
Aim 2: Implement study in 1 urban & 1 rural daycares; complete enrollment of 12 dyads, collect baseline data, begin intervention in both daycares for 5 weeks; evaluate recruitment, data collection/management, and intervention fidelity.
Aim 3: Analyze evaluative data from both caregivers and teachers to determine their satisfaction and recommendations to guide UH3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None (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
- •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 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.
研究组 & 干预措施
Food-Body-Mind Intervention
Guided by the Actor-Partner Interdependence Model, the Allostatic Load Model, and the Transactional Theory of Stress and Coping, the pilot 5-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.
干预措施: Food-Body-Mind Intervention (Behavioral)
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' 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))
- Caregivers' stress(Month 0 (Time 1))
研究者
Jiying Ling
Associate Professor
Michigan State University