Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.

BackgroundThe Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments.PurposeOur purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators.MethodsTRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow’s milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants.ResultsThis study was conducted in the United States, Canada, Australia, and 12 countries...