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Table 2 Changes in study design

From: Formative research implications on design of a randomized controlled trial for oral health promotion in children

Original study design Challenge identified Final study design
All data collected in homes Some of the families identified as high-risk and most in need of the intervention were uncomfortable with letting someone into their home.
Some clinics/WIC centers did not have sufficient space for data collection at the site.
Data collection in the home is still the primary goal, but we now also allow data collection to occur in the clinic/WIC centers or in another location (e.g., relative’s house).
Factorial design that included the following groups:
 - CHW in clinic only
 - CHW in WIC only
 - CHW in home only
 - CHW in clinic and home
 - CHW in WIC and home
 - No CHW
Families were less trusting of a CHW intervention that is not associated with a clinic or WIC center.
Clinics and WIC centers expect CHWs to be flexible and meet families in settings outside of the clinic/WIC center
We simplified the design to a two-arm cluster randomized trial with wait-list control. One arm gets a CHW assigned to the clinic/WIC center, and the other receives CHW services when the study is over. CHWs work in the clinic/WIC and in homes, as preferred by families.
Oral health topics for CHW intervention chosen by investigators. The specific needs of families did not align exactly with the topics chosen. Oral health topics for CHW intervention were tailored to fit the specific needs of the families.