Background The 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. Purpose Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. Methods TRIGR was designed to test whether weaning to formula containing hydrolyzed vs. 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. Results The study was conducted in the United States, Canada, Australia and 12 countries in Europe. Of the 5,606 mothers registered world-wide, 5,000 of their infants were randomized. Of these, 2,159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of the study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery amongst T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation. Limitations Our experience is limited to a single international multicenter trial. Conclusions TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child.
Graduates of a 1970s training program for women demonstrated that they had expanded the social change and voluntarism agenda of their earlier training to incorporate feminism and personal action in the workplace. These women were active professionals espousing personal achievement and individual voluntarism, yet they had forsworn col lective action. They mirror the oddity of American feminism in defin ing even social change in individualistic terms.
A random sample of 84 past and present Temporary Assistance to Needy Families recipients in Hennepin County, Minnesota, were interviewed regarding their health care coverage and corresponding work histories over a 42-month period. Diverse racial-ethnic and immigrant groups of color were oversampled. A life history calendar technique and supplementary interview questions were utilized. The researchers found an inverse relationship between amount of paid work and health care coverage. Different racial-ethnic and immigrant groups had different patterns of health care coverage that were not explained sufficiently by amount of paid work. The authors posit that a lack of a publicly known linkage between paid work and Medicaid resulted in uninsurance for low-income workers and call for further research to explain different insurance patterns among racial-ethnic groups.
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