Effectiveness of an Educational Intervention to Maintain Exclusive Breastfeeding (PROLACT)

Gerencia de Atención Primaria, Madrid

Status: Completed

Conditions: Exclusive Breastfeeding

Treatments: Behavioral: Usual care; Behavioral: Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT01869920

PI12/02609_PI12/02020

Details and patient eligibility

About

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

Full 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.

Enrollment: 434 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female 18 years old or older,
• mother-infant pairs using exclusive breastfeeding,
• Signed Informed Consent

Exclusion criteria

• Any medical conditions that prevents breastfeeding
• infant should be not older than four weeks

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 2 patient groups

intervention group

Experimental group

Description:

Intervention group receive a training education on breastfeeding. Education training is provided by an expert group from General Direction of Primary Care

Treatment:

Behavioral: Intervention group

Controll group

Other group

Description:

Usual care

Treatment:

Behavioral: Usual care