Overweight in Preschool Age Children Clinical Trial
Official title:
Improving Primary Care to Prevent Childhood Obesity
To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.
Overweight in the preschool age group is prevalent, increasing, and of consequence. During
the last 30 years in the U.S., the prevalence of overweight among youth has dramatically
increased. Overweight in young children is associated with later overweight, with childhood
conditions such as hyperlipidemia, hypertension, and type II diabetes, and with higher
morbidity and mortality in adulthood.
Along with the long-term risks associated with overweight in the preschool age group, there
come unique opportunities to intervene and alter the subsequent course of health and disease
for these individuals. These regular visits allow both detection of elevated BMI levels and
opportunities for intervention.
The overall goal of this research is to assess a comprehensive, innovative, primary care
practice change intervention to prevent obesity among children age 2 through 5 years at
elevated risk of obesity. To achieve this goal, we will conduct a cluster-randomized
controlled trial in 10 pediatric practices of Harvard Vanguard Medical Associates, a large
multi-site group practice in eastern Massachusetts with a track record of research
collaboration.
We will randomize five health centers to the intervention condition, and five health centers
to the control (usual care) condition. The intervention will consist of state-of-the-science
approaches to changing dietary, activity, and inactivity behaviors among the children.
The intervention period will be 1 year, followed by a 1 1/2 year maintenance follow-up
period. Frequency of visits will be every 6 weeks for the first 6 months, and every 6 months
after that. Participating families will complete a telephone-administered interview at
baseline and all follow-up timepoints. There will be 3 types of measurements: 1)
measurements made by the clinical staff that will also be used for outcomes in the research
study (only height and weight); 2) measurements made by clinicians for feedback during
counseling sessions, which will not be used for study outcomes; and 3) measurements made by
the research staff for study outcomes and processes.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention