Healthy Caregivers-Healthy Children Phase 3: Children With Special Needs
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index Percentile
研究概览
简要总结
The purpose of the study is to further develop and examine the Health Caregivers Healthy Children (HC2) program, which encourages obesity prevention through promoting healthy eating and physical activity.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •have >30 children ages 2-to-5 with a with or at-risk for a disability or special healthcare need
- •Serve low income families
- •Reflect the ethnic diversity of the Miami Dade county Public School System (60% Hispanic, 20% non-Hispanic Black, 20% Non Hispanic White).
- •Child inclusion criteria:
- •Children with an Individual Education Plan or at-risk based on social and economic variables
- •child ages 2-5
- •child enrolled in a childcare center
排除标准
- •Children with feeding tubes or those that bring their own meals due to dietary restrictions
结局指标
主要结局
Change in Body Mass Index Percentile
时间窗: Baseline, Up to 3 years
Body mass index will be collected on children enrolled using participant's height and weight using a percentile score from 0-100
Change in Environment and Policy Assessment and Observation tool) and the Healthy Environment Rating Scale
时间窗: Baseline, Up to 3 years
Environment and Policy Assessment and Observation Tool has a total score ranging from 0-100 with the higher score indicating greater quality of nutrition
次要结局
- Change in Healthy Caregivers-Healthy Children (HC2) Survey(Baseline, Up to 3 years)
- Change in Childcare Worker Job Stress Index(Baseline, Up to 3 years)
- Change in Health Environment Rating Scale(Baseline, Up to 3 years)
- Change in Parent Stress Index(Baseline, Up to 3 years)
研究者
Ruby Natale
Associate Professor of Clinical Pediatrics
University of Miami