Abstract
Background: The rates of exclusive breastfeeding at 6 months in Spain are far from the target 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.Method: Multicentre cluster randomized clinical trial. A total of 434 mother-child dyads (215 in the control group and 219 in the intervention group) who breastfed exclusively in the first 4 weeks of the infant's life and agreed to participate were included. The main outcome variable was exclusive breastfeeding at 6 months. Secondary variables were the 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 according to intention to treat.Results: The percentage of dyads with exclusive breastfeeding at 6 months was 22.4% in the intervention group and 8.8% in the control group. The PROLACT intervention obtained an RR of 2.53 (95% CI 1.54-4.15) and an NNT of 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); monthly income/person > 833.33 €, OR 2.15 (95% CI: 0.996-4.65); planning to start work before the infant was 6 months old, OR 0.35 (0.19-0.63); and use of a pacifier, OR 0.58 (95% CI 0.30-1.11).Conclusions: The PROLACT group educational intervention in primary care is more effective than the usual practice for maintaining exclusive breastfeeding at 6 months.Trial registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).
Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project)
