Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados) (SIALAC)

January 10, 2017 updated by: Olga López-Dicastillo, Clinica Universidad de Navarra, Universidad de Navarra

A Complex Intervention to Promote Breastfeeding Self-efficacy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clinica Universidad de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Departamento de Ciencias de la Salud. Universidad Pública de Navarra
      • Pamplona, Navarra, Spain, 31008
        • Facultad de Enfermería. Universidad de Navarra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The intervention consisted on breastfeeding support at three stages: a) week 28-39 pregnancy: women were provided with written information and watch a breastfeeding self-efficacy enhancing video; b) during hospitalization after birth: based on their responses to the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire and the observation of a whole breastfeed, nurses provided specific advice using active listening. All the relevant information was registered; c) within one week after birth: a nurse or midwife made a phone call to follow-up mothers breastfeeding behaviour, addressing issues that during the hospitalization needed reinforcement, solving any question or matter that they had and providing positive reinforcement.
Behavioral: Breastfeeding support
Self-efficacy
Other Names:
  • SIALAC
No Intervention: Control: Standard Care

This group received standard antenatal and postnatal care by midwives and nurses caring for them during their regular antenatal visits and after delivery.

The professionals delivering the intervention were the same than those providing the standard care. That was the reason to first collect the data from the control group and after that organising the training of health professionals to deliver de intervention.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Universidad Pública de Navarra
Complejo Hospitalario de Navarra

Investigators

  • Principal Investigator: Elena Antoñanzas, MSc,BSc,RN, Complejo Hospitalario de Navarra
  • Principal Investigator: Olga Lopez-Dicastilo, PhD,MSc,BSc, University of Navarra

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NUR-SIALAC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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