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Clinical Trials/NCT03019484
NCT03019484
Completed
Not Applicable

A Complex Intervention to Promote Breastfeeding Self-efficacy

Clinica Universidad de Navarra, Universidad de Navarra4 sites in 1 country125 target enrollmentApril 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Feeding
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Enrollment
125
Locations
4
Primary Endpoint
Changes on Breastfeeding status reported by mothers
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of the study was to evaluate the effectiveness of a breastfeeding self-efficacy promotion intervention. More specifically our objectives were to: explore changes in self-efficacy following the intervention; explore changes in the initiation and maintenance of breastfeeding following the intervention.

Detailed Description

Breastfeeding is the optimal choice for feeding infants in order to ensure a healthy growth and development. Although breastfeeding has many benefits for the infant and the mother, breastfeeding rates drop drastically during the first three months after birth. There is a number of factors that influence the initiation and maintenance of breastfeeding. One of the key factors is maternal self-efficacy in relation to breastfeeding. The aim of the study was the development and evaluation of an intervention to enhance maternal perceived self-efficacy in order to contribute positively to the initiation and maintenance of breastfeeding. This was done by using a complex intervention approach (MRC framework) to design and assess a multi-center controlled trial, involving midwives and nurses working at the Complejo Hospitalario de Navarra (CHN) of the Servicio Navarro de Salud and at the Clínica Universidad de Navarra (CUN). These health professionals were trained to deliver the intervention. The intervention was focused on self-efficacy related aspects and took place at three instances with every mother: in the final stage of pregnancy, during the maternal hospital stay after giving birth, and in the first days after discharge. The participants in the control group received the standard care as provided in each health institution.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
November 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Responsible Party
Principal Investigator
Principal Investigator

Olga López-Dicastillo

PhD

University of Navarra

Eligibility Criteria

Inclusion Criteria

  • Intention to breastfeed and no contraindication to do so
  • Speak Spanish
  • Give informed consent

Exclusion Criteria

  • Unwillingness to breastfeed
  • Preterm birth (at \<37 weeks gestation)
  • Breastfeeding contraindication (galactosemia)
  • Breastfeeding-related especial situations (multiple birth; newborn weight \<2000g; leporine lip; newborn in intensive care unit)

Outcomes

Primary Outcomes

Changes on Breastfeeding status reported by mothers

Time Frame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth

The mothers reported whether they were breastfeeding or not.

Changes on maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire

Time Frame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth

The mothers completed the questionnaire in person in T1 and by phone in T2, T3 and T4

Study Sites (4)

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