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

This study is not yet open for participant recruitment.
Verified June 2013 by Gerencia de Atención Primaria, Madrid
Sponsor:
Information provided by (Responsible Party):
Susana Martín Iglesias, Gerencia de Atención Primaria, Madrid
ClinicalTrials.gov Identifier:
NCT01869920
First received: June 3, 2013
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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:
  • Effective Breast Feeding (EBF) [ Time Frame: six months ] [ Designated as safety issue: No ]
    Evaluate the presence of EBF 6 months after educational intervention.


Secondary Outcome Measures:
  • Type of breastfeeding, duration of EBF, reasons for breastfeeding withdrawal, intervention satisfaction (SERVQUAL). [ Time Frame: Six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 432
Study Start Date: December 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 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 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 attending any query in 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 EBF at six months. Secondary variables: types of breastfeeding at 6 months, duration of EBF, reasons for abandoning 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 types 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01869920

Locations
Spain
Gerencia de Atencion Primaria
Madrid, Spain
Sponsors and Collaborators
Gerencia de Atención Primaria, Madrid
Investigators
Principal Investigator: María J Santamaría, Nurse Gerencia de Atención Primaria, Madrid
  More Information

No publications provided

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
Study First Received: June 3, 2013
Last Updated: June 4, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Gerencia de Atención Primaria, Madrid:
breastfeeding
education
intervention

ClinicalTrials.gov processed this record on April 17, 2014