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.
研究组 & 干预措施
Clinically Based: Healthy Weight Clinic
All families referred to the Healthy Weight Clinic intervention arm will be scheduled for a 30-45 minute orientation clinic visit to orient the child and family to the program. During this visit, the family will meet with the community health worker who will provide a schedule of clinic visits and dietitian contacts. The community health worker will assess the child's social and environmental context to allow treatment tailoring. For the first 6 months, each family will be asked to attend two clinic visits per month and complete weekly 20-30 minute contacts with the dietitian via telephone. The program aims to deliver approximately 30 contact hours in the 6-month period. This will be followed by monthly visits to the Healthy Weight Clinic and monthly calls with their dietitian.
干预措施: Healthy Weight Clinic (Behavioral)
Community Based: Healthy Weight & Your Child
All families referred to the Healthy Weight and Your Child intervention arm will be scheduled for a 60-minute family information session to orient the child and family to the program. During this visit, the family will receive information about the program and logistics such as program schedule and format and attendance. The program is delivered over 12 months, which includes 16 weekly sessions, followed by 4 sessions delivered every other week and concluding with 5 monthly sessions. Most sessions are 2 hours in length and include a group of about 8-15 children and their caregivers. The first hour is delivered in a classroom setting and the second hour in an additional area conducive for physical activity.
干预措施: Healthy Weight and Your Child (Behavioral)
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