Overweight and Obesity
Conditions
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.
Interventions
BEHAVIORALHealthy Weight Clinic
BEHAVIORALHealthy Weight and Your Child
Sponsors
Massachusetts Department of Health
Y-USA
Yale University
Harvard School of Public Health (HSPH)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Children were randomized to either: 1) federally qualified health center-based Healthy Weight Clinic, or 2) YMCA community-based Healthy Weight and Your Child Program. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Child BMI at 12 months | 0-12 months |
| Change in Child BMI percent of the 95th percentile at 12 months | 0-12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Screen Time at 12 months | 0-12 months | Average hours per day of screen time as reported by parent |
| Change in Sleep Duration at 12 months | 0-12 months | Average hours per day of sleep as reported by parent |
| Change in Physical Activity at 12 months | 0-12 months | Average number of days (0-7) child is physically active for at least 60 minutes as reported by parent |
| Change in Diet at 12 months | 0-12 months | Average daily intake of sugar-sweetened beverages and weekly intake of fast food as reported by parent |
Outcome results
None listed