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Lookup NU author(s): Sharon King, Dr Claire Owen, Professor Steve RobsonORCiD
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND).
© 2026. The Author(s). Georg Thieme Verlag KG, Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany.Understanding the determinants that influence parents' decisions to participate with their infants in primary prevention trials is essential for achieving representative study samples and ensuring the generalizability of outcomes. We analyzed quantitative and qualitative data collected from infants eligible for the Primary Oral Insulin Trial (N =2,750) or the Supplementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity Trial (N =3,309). Both trials were conducted within the Global Platform for the Prevention of Autoimmune Diabetes between 07/2017 and 04/2024. Among all eligible infants, a longer decision time (odds ratio: 1.01, 95% confidence interval: 1.00-1.01, and p =0.002), having a first-degree relative with type 1 diabetes (odds ratio: 2.18, 95% confidence interval: 1.95-2.43, and p <0.001), and a higher maternal age (odds ratio: 1.03, 95% confidence interval: 1.01-1.05, and p =0.003) were associated with a higher likelihood of participation, whereas infants born in fall (odds ratio: 0.85, 95% confidence interval: 0.73-0.98, and p =0.03) and families with longer travel distances to the study center (odds ratio: 0.97, 95% confidence interval: 0.95-0.99, and p =0.01) were less likely to participate. Participation was lower in the Supplementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity Trial than in the Primary Oral Insulin Trial (odds ratio: 0.86, 95% confidence interval: 0.78-0.96, and p =0.005), and stratified analyses indicated that some factors, such as recruitment during the COVID-19 pandemic, affected participation differently between studies. Analysis of qualitative data from 638 families identified additional factors, including the parental perception of the child's risk for type 1 diabetes and the burden of participation. In conclusion, this study identifies both general and study-specific determinants and reasons of participation and non-participation in infant primary prevention trials.
Author(s): Worl F, Achenbach P, Bonifacio E, Casteels K, Gemulla G, Haupt F, Hawkins S, Hommel A, King S, Kordonouri O, Elding Larsson H, Loff A, Lundgren M, Nenonen H, Oltarzewski M, Owen C, Paulus J, Robson S, Roloff F, Snape M, Szypowska A, Vatish M, Weibeta A, Winkler C, Zych A, Ziegler A-G, Hummel S
Publication type: Article
Publication status: Published
Journal: Hormone and Metabolic Research
Year: 2026
Pages: epub ahead of print
Online publication date: 01/07/2026
Acceptance date: 27/05/2026
Date deposited: 16/07/2026
ISSN (print): 0018-5043
ISSN (electronic): 1439-4286
Publisher: Georg Thieme Verlag
URL: https://doi.org/10.1055/a-2884-2277
DOI: 10.1055/a-2884-2277
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