NCT01869920

Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding

Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 434 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding

Detailed description

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.

Conditions

• Exclusive Breastfeeding

Interventions

Type	Name	Description
BEHAVIORAL	Intervention group	Education on breastfeeding
BEHAVIORAL	Usual care	Usual care

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2013-06-05
• Last updated: 2017-08-22

Locations

1 site across 1 country: Spain