Childhood Obesity Research Demonstration Project 2.0 (CORD 2.0)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Overweight and Obesity
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 407
- Primary Endpoint
- Change in Child BMI at 12 months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Elsie Taveras, MD
Chief, Division of General Academic Pediatrics
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Change in Child BMI at 12 months
Time Frame: 0-12 months
Change in Child BMI percent of the 95th percentile at 12 months
Time Frame: 0-12 months
Secondary Outcomes
- 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)