Exclusive Breastfeeding Clinical Trial
Official title:
Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding
Objective: Evaluate the effectiveness of an educational group intervention performed by
primary healthcare professionals in terms of increasing the proportion of mother-infant pairs
using exclusive breastfeeding at six months compared to routine practice. Design: cluster
randomized trial. Setting: Multicentre. Primary Care Health Centres (PCHC). Madrid. Subjects:
mother-infant pairs using exclusive breastfeeding who come for any query to the health
centre, as long as the infant is not older than four weeks and who consent to participate in
the study.
Sample size: N= 432 (216 in each arm). Randomisation: Unit of randomization: primary
healthcare centres.
Analysis unit: mother-infant pairs, recruitment to consecutive sampling. Intervention:
Educational group intervention in the treatment group and the usual intervention in the
control group.
Variables: Main response variable: mother-infant pairs using exclusive breastfeeding (EBF) at
six months. Secondary variables: type of breastfeeding at 6 months, duration of EBF, reasons
for ceasing breastfeeding, satisfaction with the intervention (SERVQUAL). Prognostic
variables: infant, mother and professional.
Data Analysis: Analysis of main effectiveness by intention to treat, comparing the proportion
of mother-infant pairs using EBF at six months in both groups. The estimation adjusted using
an explanatory logistics regression model. To assess the effect of the educational group
intervention on the duration of the various type of breastfeeding, a survival analysis will
be used comparing the two groups using the log-rank test. The control of potential
confounding variables will be performed by the construction of various Cox regression models.
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