RT Journal Article T1 Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study A1 Martín Iglesias, Susana A1 Santamaría Martín, M. Jesús A1 Alonso Álvarez, Ahinoa A1 Rico Blázquez, Milagros A1 del Cura González, Isabel A1 Rodríguez Barrientosn, Ricardo A1 Barberá Martín, Aurora A1 Sanz Cuesta, Teresa A1 Isabel Coghen Vigueras, M. A1 de Antonio Ramírez, Isabel A1 Durand Rincón, Isabel A1 Garrido Rodriguez, Felisa A1 Geijo Rincón, María Jesús A1 Mielgo Salvador, Rebeca A1 Morales Montalvá, M. Soledad A1 Reviriego Gutiérrez, M. Asunción A1 Rivero Garrido, Carmen A1 Ruiz Calabria, Micaela A1 Santamaría Mechano, M. Pilar A1 Santiago Fernández, Roberto A1 Sillero Quintana, M. Isabel A1 Soto Almendro, Beatriz A1 Terol Claramonte, María A1 Villa Arranz, María AB BackgroundThe World Health Organization leads a global strategy to promote the initiation and maintenance of breast-feeding.Existing literature shows that education and supportive interventions, both for breast-feeding mothers as well as for healthcare professionals, can increase the proportion of women that use exclusive breast-feeding, however, more evidence is needed on the effectiveness of group interventions.MethodsThis study involves a community-based cluster randomised trial conducted at Primary Healthcare Centres in the Community of Madrid (Spain). The project aims to evaluate the effectiveness of an educational group intervention performed by primary healthcare professionals in increasing the proportion of mother-infant pairs using exclusive breastfeeding at six months compared to routine practice.The number of patients required will be 432 (216 in each arm). All mother-infant pairs using exclusive breastfeeding that seek care or information at healthcare centres will be included, as long as the infant is not older than four weeks, and the mother has used exclusive breastfeeding in the last 24 h and who gives consent to participate.The main response variable is mother-infant pairs using exclusive breast-feeding at six months.Main effectiveness will be analysed by comparing the proportion of mother-infant pairs using exclusive breast-feeding at six months between the intervention group and the control group. All statistical tests will be performed with intention-to-treat. The estimation will be adjusted using an explanatory logistic regression model. A survival analysis will be used to compare the two groups using the log-rank test to assess the effect of the intervention on the duration of breastfeeding. The control of potential confounding variables will be performed through the construction of Cox regression models.DiscussionWe must implement strategies with scientific evidence to improve the percentage of exclusive breast-feeding at six months in our environment as established by the WHO. Group education is an instrument used by professionals in Primary Care that favours the acquisition of skills and modification of already-acquired behaviour, all making it a potential method of choice to improve rates of exclusive breast-feeding in this period.Trial registrationThe trial was registered with ClinicalTrials.gov under code number NCT01869920 (Date of registration: June 3, 2013). PB BioMed Central Ltd SN 1471-2393 YR 2018 FD 2018-02-26 LK https://hdl.handle.net/20.500.14352/122658 UL https://hdl.handle.net/20.500.14352/122658 LA eng NO Martín-Iglesias S, Santamaría-Martín MJ, Alonso-Álvarez A, Rico-Blázquez M, del Cura-González I, Rodríguez-Barrientosn R, et al. Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study. BMC Pregnancy and Childbirth. 2018;18(1). NO Este estudio fue financiado por los proyectos PI12/02609 y PI12/02020 como parte del Plan Nacional de I+D+i, y cofinanciado por el ISCIII–Subdirección General de Evaluación y el Fondo Europeo de Desarrollo Regional (FEDER). La fuente de financiación no tuvo ningún papel en el diseño de este estudio y no lo tendrá durante su ejecución, análisis, interpretación de los datos ni en la decisión de publicar los resultados. DS Docta Complutense RD 25 abr 2026