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

María Jesús Santamaría-Martín, Susana Martín-Iglesias, Christine Schwarz, Milagros Rico-Blázquez, Julián Alexander Portocarrero-Nuñez, Laura Diez-Izquierdo, Laura Llamosas-Falcón, Ricardo Rodríguez-Barrientos, Isabel Del-Cura-González, Grupo PROLACT, Francisca Martín-Llorente, Leopoldo Casero-Perona, Paz Plasencia-Plasencia, Marta Yolanda Sánchez-Méndez, Pilar Santamaría-Medrano, Rebeca Mielgo-Salvador, Carolina Cañón-Cañón, Dolores Valor-Sánchez, Ramona Fernández-Fernández, Soledad López-Lozano, Marisol Morales-Montalva, María Elena Pérez-Mañanes, Isabel Durand-Rincón, Sara Valdecantos-Coscollano, Verónica Hernández-Hernández, Maria Dolores Noceco-Paredes, Clara Malde-García, Ma Ángeles Miranda-Martín, Nuria de la Peña Antón, Elena Martín-Díaz, Dolores Robas-García, Manuel Parra-Moro, María Concepción Ruiz-Del-Castillo, Maria Jesús Geijo-Rincón, Carmen Rivero-Garrido, María Gema Alameda-Hernández, Miriam González-Macías, Isabel Coghen-Vigueras, Raquel Arenas-Yaguez, Carolina San Pablo-Campos, Rosa M Prados-Bueno, Ma Adoración Bejarano-López, Natividad García-Ruiz, Gema Magdaleno-Del-Rey, Lucía Tirado-Jiménez, Ma Jesús Santamaria-Martín, Asunción Reviriego-Gutierrez, Beatriz Soto-Almendro, Paula García-Romero, Elena Zarco-Cid, María Villa-Arranz, Alma Mejía Fernández-de-Velasco, Laura Anta-Rodríguez, María Isabel Sánchez-Prieto-Emmanuel, Luz Divina Barrios-García, Carmen Lozano-Adeva, Luis Mariano Casado-García, Lourdes Gómez-Pérez, Ma Dolores Martínez-Sierra, Martha Olga Escobar-García, Ma Dolores Guerra-Nieto, Elena Azcona-Domínguez, María Ángeles Delgado-Domínguez, Rafael Verdugo-Hernández, María Jesús Santamaría-Martín, Susana Martín-Iglesias, Christine Schwarz, Milagros Rico-Blázquez, Julián Alexander Portocarrero-Nuñez, Laura Diez-Izquierdo, Laura Llamosas-Falcón, Ricardo Rodríguez-Barrientos, Isabel Del-Cura-González, Grupo PROLACT, Francisca Martín-Llorente, Leopoldo Casero-Perona, Paz Plasencia-Plasencia, Marta Yolanda Sánchez-Méndez, Pilar Santamaría-Medrano, Rebeca Mielgo-Salvador, Carolina Cañón-Cañón, Dolores Valor-Sánchez, Ramona Fernández-Fernández, Soledad López-Lozano, Marisol Morales-Montalva, María Elena Pérez-Mañanes, Isabel Durand-Rincón, Sara Valdecantos-Coscollano, Verónica Hernández-Hernández, Maria Dolores Noceco-Paredes, Clara Malde-García, Ma Ángeles Miranda-Martín, Nuria de la Peña Antón, Elena Martín-Díaz, Dolores Robas-García, Manuel Parra-Moro, María Concepción Ruiz-Del-Castillo, Maria Jesús Geijo-Rincón, Carmen Rivero-Garrido, María Gema Alameda-Hernández, Miriam González-Macías, Isabel Coghen-Vigueras, Raquel Arenas-Yaguez, Carolina San Pablo-Campos, Rosa M Prados-Bueno, Ma Adoración Bejarano-López, Natividad García-Ruiz, Gema Magdaleno-Del-Rey, Lucía Tirado-Jiménez, Ma Jesús Santamaria-Martín, Asunción Reviriego-Gutierrez, Beatriz Soto-Almendro, Paula García-Romero, Elena Zarco-Cid, María Villa-Arranz, Alma Mejía Fernández-de-Velasco, Laura Anta-Rodríguez, María Isabel Sánchez-Prieto-Emmanuel, Luz Divina Barrios-García, Carmen Lozano-Adeva, Luis Mariano Casado-García, Lourdes Gómez-Pérez, Ma Dolores Martínez-Sierra, Martha Olga Escobar-García, Ma Dolores Guerra-Nieto, Elena Azcona-Domínguez, María Ángeles Delgado-Domínguez, Rafael Verdugo-Hernández

Abstract

Background: The 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.

Method: Multicentre 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.

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. 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) .

Conclusions: The 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 registration: The trial was registered with ClinicalTrials.gov under code number NCT01869920 (03/06/2013).

Keywords: Breast-feeding; Clinical trial; Health education; Health promotion; Primary healthcare.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The flow of participants and the reasons for the losses
Fig. 2
Fig. 2
Prevalence of the different types of breastfeeding after 6 months in the intervention and control group

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Source: PubMed

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