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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Pública de Navarra
Complejo Hospitalario de Navarra

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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