BioMed research international · 2026
Recruitment Challenges in Mother-Infant Research: Factors Associated With Low Enrollment and Inclusion in the Synbio-Breast Study.
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Simons Sandra, van Goudoever Hans, Vlieg-Boerstra Berber
Аннотация
BACKGROUND: An optimal early-life environment is crucial for child health, with human milk and the infant microbiome playing central roles. The Synbio-Breast study investigates how maternal diet contributes to the synbiotic composition of human milk in atopic women. Despite increasing societal interest in this topic, recruitment proved challenging.
OBJECTIVE: The aim of this study is to quantify and analyze factors associated with low enrollment and inclusion rates and to explore strategies for improving recruitment in future mother-infant studies.
METHODS: Enrollment and inclusion rates and temporal trends were assessed using linear regression models, whereas associations between facilitating factors-including involvement of the PhD student, recruitment strategy, lactation meetings, and attendance at the Nine Months Fair-and enrollment were assessed using logistic regression models.
RESULTS: Of the 681 women screened, 215 expressed willingness to participate. Despite multiple efforts and adaptations to enhance engagement, enrollment remained low. After adjusting for the COVID-19 period, only recruitment conducted by the PhD student via email-without personal contact through a healthcare professional-was significantly associated with lower odds of enrollment. Of the 215 enrolled participants, 75 were ultimately included (11% of all screened women). Key reasons for exclusion were partial breastfeeding (30.0%), antibiotic use (22.1%), and loss of interest (19.3%).
CONCLUSION: Strict inclusion and exclusion criteria contributed to substantial low enrollment and inclusion rates in the Synbio-Breast study. Successful recruitment in mother-infant research requires more than logistical organization; it depends on personalized engagement built on existing relationships of trust. Moreover, studies that offer no direct health benefit to participants-such as the Synbio-Breast study-tend to have inherently lower uptake, underscoring the need for tailored and relationship-based recruitment strategies.
OBJECTIVE: The aim of this study is to quantify and analyze factors associated with low enrollment and inclusion rates and to explore strategies for improving recruitment in future mother-infant studies.
METHODS: Enrollment and inclusion rates and temporal trends were assessed using linear regression models, whereas associations between facilitating factors-including involvement of the PhD student, recruitment strategy, lactation meetings, and attendance at the Nine Months Fair-and enrollment were assessed using logistic regression models.
RESULTS: Of the 681 women screened, 215 expressed willingness to participate. Despite multiple efforts and adaptations to enhance engagement, enrollment remained low. After adjusting for the COVID-19 period, only recruitment conducted by the PhD student via email-without personal contact through a healthcare professional-was significantly associated with lower odds of enrollment. Of the 215 enrolled participants, 75 were ultimately included (11% of all screened women). Key reasons for exclusion were partial breastfeeding (30.0%), antibiotic use (22.1%), and loss of interest (19.3%).
CONCLUSION: Strict inclusion and exclusion criteria contributed to substantial low enrollment and inclusion rates in the Synbio-Breast study. Successful recruitment in mother-infant research requires more than logistical organization; it depends on personalized engagement built on existing relationships of trust. Moreover, studies that offer no direct health benefit to participants-such as the Synbio-Breast study-tend to have inherently lower uptake, underscoring the need for tailored and relationship-based recruitment strategies.