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Wörl, F. ; Achenbach, P. ; Bonifacio, E. ; Casteels, K.* ; Gemulla, G.* ; Haupt, F. ; Hawkins, S.* ; Hommel, A.* ; King, S.* ; Kordonouri, O.* ; Larsson, H.E.* ; Loff, A.* ; Lundgren, M.* ; Nenonen, H.* ; Ołtarzewski, M.* ; Owen, C.* ; Paulus, J.* ; Robson, S.* ; Roloff, F.* ; Snape, M.* ; Szypowska, A.* ; Vatish, M.* ; Weiss, A. ; Winkler, C. ; Zych, A.* ; Ziegler, A.-G. ; Hummel, S.

Determinants of infant participation and non-participation in primary prevention trials.

Horm. Metab. Res., DOI: 10.1055/a-2884-2277 (2026)
Publ. Version/Full Text DOI PMC
Open Access Hybrid
Creative Commons Lizenzvertrag
Understanding the determinants that influence parents’ decisions to participate with their infants in primary prevention trialsis essential for achieving representative study samples and ensuring the generalizability of outcomes. We analyzed quantitativeand 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 Platformfor 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 (oddsratio: 2.18, 95 % confidence interval: 1.95–2.43, and p < 0.001), and a higher maternal age (odds ratio: 1.03, 95 % confidenceinterval: 1.01–1.05, and p = 0.003) were associated with a higher likelihood of participation, whereas infants born in fall (oddsratio: 0.85, 95 % confidence interval: 0.73–0.98, and p = 0.03) and families with longer travel distances to the study center (oddsratio: 0.97, 95 % confidence interval: 0.95-0.99, and p = 0.01) were less likely to participate. Participation was lower in the Sup-plementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity Trial than in the Primary Oral Insulin Trial (oddsratio: 0.86, 95 % confidence interval: 0.78–0.96, and p = 0.005), and stratified analyses indicated that some factors, such as re-cruitment during the COVID-19 pandemic, affected participation differently between studies. Analysis of qualitative data from638 families identified additional factors, including the parental perception of the child’s risk for type 1 diabetes and the burdenof participation. In conclusion, this study identifies both general and study-specific determinants and reasons of participationand non-participation in infant primary prevention trials.
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Publication type Article: Journal article
Document type Scientific Article
Keywords Generalizability Theory ; Confidence Interval ; Diabetes Mellitus ; Type 1 Diabetes ; Type 2 Diabetes ; Clinical Trial ; Relative Risk; Clinical-research; Decision-making
ISSN (print) / ISBN 0018-5043
e-ISSN 1439-4286
Journal Hormone and Metabolic Research
Publisher Thieme
Publishing Place Oswald-hesse-strasse 50, D-70469 Stuttgart, Germany
Reviewing status Peer reviewed
Institute(s) Institute of Diabetes Research (IDF)
Institute of Pancreatic Islet Research (IPI)
Institute of Diabetes and Obesity (IDO)
Grants Bundesministerium für Bildung und Forschung
EASD-Novo Nordisk Foundation Diabetes Prize for Excellence to AGZ (Helmholtz Munich)
The Leona M. and Harry B. Helmsley Charitable Trust