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

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ClinicalTrials.gov Identifier: NCT01869920
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Exclusive Breastfeeding Behavioral: Intervention group Behavioral: 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 434 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2015
Primary Completion Date : June 2017
Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

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

Secondary Outcome Measures :
  1. Type of breastfeeding and duration of EBF [ Time Frame: Six months ]
    EBF or not exclusive breastfeeding and duration in months

  2. breastfeeding ceasing [ Time Frame: During follow-up ]
    Reasons for breastfeeding ceasing

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869920

Gerencia de Atencion Primaria
Madrid, Spain
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
ClinicalTrials.gov Identifier: NCT01869920     History of Changes
Other Study ID Numbers: PI12/02609_PI12/02020
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Susana Martín Iglesias, Gerencia de Atención Primaria, Madrid: