Effectiveness of a group educational intervention - prolact - in primary care to promote exclusive breastfeeding: a cluster randomized clinical trial

Background: The rates of exclusive breastfeeding at 6months in Spain are far from recommended by the World Health Organization, which is 50% by 2025. Evidence of the efectiveness of group interventions in late postpartum is limited. The objective of this study was to evaluate the efectiveness of the PROLACT group educational intervention for increasing the proportion of mother-child dyads with exclusive breastfeeding at 6months compared to the usual practice in primary care. Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads who breastfed exclusively in the frst 4weeks of the children’s life and agreed to participate were included. The main outcome was exclusive breast‑feeding at 6months. Secondary variables were type of breastfeeding, reasons for abandonment, degree of adherence and satisfaction with the intervention. To study the efectiveness, the diference in the proportions of dyads with exclusive breastfeeding at 6months 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 6months, a multilevel logistic regression model was ftted. All analyses were performed to intention to treat. Results: The percentage of dyads with exclusive breastfeeding at 6months 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 6months 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 6months old, OR=0.35 (0.19–0.63). Conclusions: The PROLACT intervention in primary care is more efective than the usual practice for maintaining exclusive breastfeeding at 6months, and can therefore be considered evidence-based practice for implementation in standard practice. Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).This study was funded by the Projects PI12/02609 and PI12/02020 as a part of the Plan Nacional de I+D+I (National Plan for R+D+I) and co-funded by the ISCIII Subdirectorate General for Evaluation and the European Regional Development Fund (ERDF). The primary researcher received a grant for publication from the Fundación para la Investigación e Innovacion en Atención Primaria (Foundation for Research and Innovation in Primary Care) in its 2019 call. The funding source had no role in the design of this study and did not have any role in its execution, analyses, interpretation of the data or the decision to submit the results.S