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Published in: BMC Pregnancy and Childbirth 1/2018

Open Access 01-12-2018 | Study protocol

Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study

Authors: Susana Martín-Iglesias, M. Jesús Santamaría-Martín, Ahinoa Alonso-Álvarez, Milagros Rico-Blázquez, Isabel del Cura-González, Ricardo Rodríguez-Barrientosn, Aurora Barberá-Martín, Teresa Sanz-Cuesta, M. Isabel Coghen-Vigueras, Isabel de Antonio-Ramírez, Isabel Durand-Rincón, Felisa Garrido-Rodriguez, María Jesús Geijo-Rincón, Rebeca Mielgo-Salvador, M. Soledad Morales-Montalvá, M. Asunción Reviriego-Gutiérrez, Carmen Rivero-Garrido, Micaela Ruiz-Calabria, M. Pilar Santamaría-Mechano, Roberto Santiago-Fernández, M. Isabel Sillero-Quintana, Beatriz Soto-Almendro, María Terol-Claramonte, María Villa-Arranz

Published in: BMC Pregnancy and Childbirth | Issue 1/2018

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Abstract

Background

The 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.

Methods

This 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.

Discussion

We 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 registration

The trial was registered with ClinicalTrials.​gov under code number NCT01869920 (Date of registration: June 3, 2013).
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Metadata
Title
Effectiveness of an educational group intervention in primary healthcare for continued exclusive breast-feeding: PROLACT study
Authors
Susana Martín-Iglesias
M. Jesús Santamaría-Martín
Ahinoa Alonso-Álvarez
Milagros Rico-Blázquez
Isabel del Cura-González
Ricardo Rodríguez-Barrientosn
Aurora Barberá-Martín
Teresa Sanz-Cuesta
M. Isabel Coghen-Vigueras
Isabel de Antonio-Ramírez
Isabel Durand-Rincón
Felisa Garrido-Rodriguez
María Jesús Geijo-Rincón
Rebeca Mielgo-Salvador
M. Soledad Morales-Montalvá
M. Asunción Reviriego-Gutiérrez
Carmen Rivero-Garrido
Micaela Ruiz-Calabria
M. Pilar Santamaría-Mechano
Roberto Santiago-Fernández
M. Isabel Sillero-Quintana
Beatriz Soto-Almendro
María Terol-Claramonte
María Villa-Arranz
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2018
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-018-1679-3

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