randomized, controlled obesity prevention trial in 28
low-income, ethnically diverse child care centers located
throughout Miami-Dade County, FL is currently being
conducted over two years (2010-present) to test the efficacy
of an intervention that poises teachers and parents
as lifestyle change agents. Trial methodology, intervention
content and outcome measures are described in detail
below.
Study design
Because it was not feasible to randomize individuals
within classrooms to different treatments, we randomly
assigned centers to treatment or control conditions.
Thus, HC2 is a group-randomized study, often referred
to as a cluster randomized trial (CRT). In CRTs, clusters
of people, or intact social units (such as childcare centers)
rather than individuals are randomized to intervention
and control groups and outcomes are measured on
individuals within those clusters. CRT designs are used
not only to evaluate group interventions but also individual
interventions where group level effects are relevant.
The University of Miami Institutional Review
Board approved all aspects of the study.