Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding (PROLACT)
|ClinicalTrials.gov Identifier: NCT01869920|
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Exclusive Breastfeeding||Behavioral: Intervention group Behavioral: Usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||434 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: intervention group
Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care
Behavioral: Intervention group
Education on breastfeeding
Behavioral: Usual care
- Exclusive breastfeeding (EBF) [ Time Frame: six months ]Evaluate the presence of EBF 6 months after educational intervention.
- Type of breastfeeding and duration of EBF [ Time Frame: Six months ]EBF or not exclusive breastfeeding and duration in months
- breastfeeding ceasing [ Time Frame: During follow-up ]Reasons for breastfeeding ceasing
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869920
|Gerencia de Atencion Primaria|
|Principal Investigator:||María J Santamaría, Nurse||Gerencia de Atención Primaria, Madrid|
|Principal Investigator:||Susana Martín, Nurse||Gerencia de Atención Primaria, Madrid|