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Determinants of Infant Participation and Non-Participation in Primary Prevention Trials

Franziska Wörl1,2,3, Peter Achenbach3,4,5, Ezio Bonifacio6,7,8

  • 1Ludwig-Maximilians-Universität München, Institute for Medical Information Processing, Biometry, and Epidemiology (IBE), Chair of Public Health and Health Service Research, LMU Medizin, Germany, Munich.

Hormone and Metabolic Research = Hormon- Und Stoffwechselforschung = Hormones Et Metabolisme
|July 1, 2026
PubMed

Insights

Parental decisions to enroll infants in type 1 diabetes prevention trials are influenced by factors like family history and maternal age. Understanding these determinants improves trial participation and generalizability for autoimmune diabetes research.

Area of Science:

  • Clinical Trials
  • Pediatric Autoimmunity
  • Diabetes Prevention

Background:

  • Representative samples are crucial for generalizability in infant prevention trials.
  • Understanding parental decision-making is key to improving recruitment and outcomes.

Purpose of the Study:

  • To identify determinants of parental participation in infant primary prevention trials for autoimmune diabetes.
  • To analyze factors influencing enrollment in the Primary Oral Insulin Trial and the Supplementation with B. INfantis for Mitigation of Type 1 Diabetes Autoimmunity Trial.

Main Methods:

  • Quantitative and qualitative data analysis from over 6,000 infants across two global prevention trials.
  • Statistical analysis of demographic, familial, and logistical factors affecting participation.
  • Thematic analysis of qualitative data from 638 families regarding perceived risk and participation burden.

Main Results:

  • Longer decision time, family history of type 1 diabetes, and higher maternal age increased participation likelihood.
  • Infants born in fall and those with longer travel distances to study centers were less likely to participate.
  • Participation varied between trials, with factors like the COVID-19 pandemic impacting recruitment differently.

Conclusions:

  • Key determinants for participation in infant prevention trials include family history, maternal age, and logistical factors.
  • Parental perception of risk and the perceived burden of participation significantly influence enrollment decisions.
  • Study-specific factors and trial design impact participation, necessitating tailored recruitment strategies for autoimmune diabetes research.

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