RT Journal Article
T1 Effectiveness of a Group Educational Intervention – Prolact - In Primary Care to Promote Exclusive Breastfeeding. A Cluster Randomized Clinical Trial.
A1 Santamaría Martín, María Jesús
A1 Martín Iglesias, Susana
A1 Schwarz, Christine
A1 Rico Blázquez, Milagros
A1 Portocarrero Nuñez, Julián Alexander
A1 Diez Izquierdo, Laura
A1 Llamosas Falcón, Laura
A1 Rodríguez Barrientos, Ricardo
A1 Cura González, Isabel del
A1 PROLACT, Group
AB BackgroundThe rates of exclusive breastfeeding at 6 months in Spain are far from recommended by the World Health Organization, which is 50% by 2025. Evidence of the effectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the effectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6 months compared to the usual practice in primary care.MethodMulticentre cluster randomized clinical trial. A total of 434 mother-child dyads who breastfed exclusively in the first 4 weeks of the children’s life and agreed to participate were included. The main outcome was exclusive breastfeeding at 6 months. Secondary variables were type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the effectiveness, the difference in the proportions of dyads with exclusive breastfeeding at 6 months was calculated, and the relative risk (RR) and number needed to treat (NNT) were calculated with their 95% CIs. To study the factors associated with the maintenance of exclusive breastfeeding at 6 months, a multilevel logistic regression model was fitted. All analyses were performed to intention to treat.ResultsThe percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. PROLACT intervention obtained an RR =2.53 (95% CI: 1.54–4.15) and an NNT = 7 (95%CI: 5–14). The factors associated with exclusive breastfeeding at 6 months were the PROLACT intervention, OR = 3.51 (95%CI: 1.55–7.93); age > 39 years, OR = 2.79 (95%CI: 1.02–7.6); previous breastfeeding experience, OR = 2.61 (95%CI: 1.29–5.29); income between 500 and 833.33 €, OR = 3.52 (95%CI 1.47–8.47).); planning to start work before the infant was 6 months old, OR = 0.35 (0.19–0.63) .ConclusionsThe PROLACT intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months, and can therefore be considered evidence-based practice for implementation in standard practice.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).
PB BioMed Central Ltd
SN 1471-2393
YR 2022
FD 2022
LK https://hdl.handle.net/20.500.14352/122440
UL https://hdl.handle.net/20.500.14352/122440
LA eng
NO Santamaría-Martín MJ, Martín-Iglesias S, Schwarz C, Rico-Blázquez M, Portocarrero-Nuñez JA, Diez-Izquierdo L, et al. Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial. BMC pregnancy and childbirth. 2022;22(1):132.
NO European Commission 
NO Instituto de Salud Carlos III
DS Docta Complutense
RD 26 feb 2026