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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Gerencia de Atención Primaria, Madrid.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Susana Martín Iglesias, Gerencia de Atención Primaria, Madrid Identifier:
First received: June 3, 2013
Last updated: April 8, 2015
Last verified: April 2015
Hypothesis: An educational intervention increases the proportion of mother-infant pairs using exclusive breastfeeding

Condition Intervention
Exclusive Breastfeeding
Behavioral: Intervention group
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effectiveness of an Educational Group Intervention in Primary Care to Maintain Exclusive Breastfeeding. Cluster Randomised Clinical Trial. PROLACT Study.

Resource links provided by NLM:

Further study details as provided by Gerencia de Atención Primaria, Madrid:

Primary Outcome Measures:
  • Exclusive breastfeeding(EBF) [ Time Frame: six months ]
    Evaluate the presence of EBF 6 months after educational intervention.

Secondary Outcome Measures:
  • Type of breastfeeding, duration of EBF, reasons for breastfeeding ceasing intervention satisfaction (SERVQUAL). [ Time Frame: Six months ]

Estimated Enrollment: 432
Study Start Date: February 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Controll group
Usual care
Behavioral: Usual care
Usual care

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01869920

Gerencia de Atencion Primaria Recruiting
Madrid, Spain
Contact: Susana Martín, Nurse   
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Principal Investigator: María J Santamaría, Nurse Gerencia de Atención Primaria, Madrid
Principal Investigator: Susana Martín, Nurse Gerencia de Atención Primaria, Madrid
  More Information

Responsible Party: Susana Martín Iglesias, Nurse, Gerencia de Atención Primaria, Madrid Identifier: NCT01869920     History of Changes
Other Study ID Numbers: PI12/02609_PI12/02020
Study First Received: June 3, 2013
Last Updated: April 8, 2015

Keywords provided by Gerencia de Atención Primaria, Madrid:
intervention processed this record on April 21, 2017