Peer-reviewed article
Determinants of Infant Participation and Non-Participation in Primary Prevention Trials.
Wörl F, Achenbach P, Bonifacio E, Casteels K, Gemulla G et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This peer-reviewed study analyzes factors that influence parents' decisions to enroll their infants in two clinical trials testing interventions to prevent type 1 diabetes autoimmunity. The research examined data from over 6,000 eligible infants and identified that factors such as family history of diabetes, maternal age, travel distance, and parental perception of risk affected enrollment rates. The study provides insights into trial recruitment challenges but does not evaluate the effectiveness of the prevention interventions themselves.
Key points
- Longer parental decision time, having a first-degree relative with type 1 diabetes, and higher maternal age were associated with higher participation rates
- Longer travel distances to study centers and being born in fall were associated with lower participation
- Participation rates differed between the two trials, suggesting study-specific factors influence enrollment
- Parental perception of the child's risk for type 1 diabetes and burden of participation were identified as additional determinants through qualitative analysis
- COVID-19 pandemic recruitment affected participation differently between the two studies
Limitations
This study examines only the determinants of trial participation and enrollment rates; it provides no evidence about whether the prevention interventions tested in these trials actually reduce type 1 diabetes risk or improve child health outcomes. The findings are specific to type 1 diabetes prevention trials and may not generalize to other primary prevention trials in different health domains.
Abstract
Abstract 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.