Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 407
- 主要终点
- Change in Child BMI at 12 months
研究概览
简要总结
This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND). The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.
详细描述
This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child is age 6.0 through 12.9 years at referral
- •child's BMI meets or exceeds the 85th percentile for age and sex
- •parent can read and respond to interviews and questionnaires in English and Spanish
排除标准
- •children who do not have at least one parent who is able to follow study procedures for 1 year
- •families who plan to leave their primary care health center within the study time frame
- •families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties
- •children who were taking medications that substantially interfere with growth
- •children who have a sibling enrolled in the study.
结局指标
主要结局
Change in Child BMI at 12 months
时间窗: 0-12 months
Change in Child BMI percent of the 95th percentile at 12 months
时间窗: 0-12 months
次要结局
- Change in Screen Time at 12 months(0-12 months)
- Change in Sleep Duration at 12 months(0-12 months)
- Change in Physical Activity at 12 months(0-12 months)
- Change in Diet at 12 months(0-12 months)
研究者
Elsie Taveras, MD
Chief, Division of General Academic Pediatrics
Massachusetts General Hospital