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Breast FeedingSIALACNCT03019484

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

A study testing Breastfeeding support in people with Breast Feeding and Self Efficacy, run by Clinica Universidad de Navarra, Universidad de Navarra at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Feeding, Self Efficacy
What is being tested?
Breastfeeding support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
4 sitesSpain
Study dates
Apr 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

4 sites in 1 country.

Spain4 sites

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Departamento de Ciencias de la Salud. Universidad Pública de Navarra

    Pamplona, Navarre, 31008

  • Facultad de Enfermería. Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Breastfeeding support
Keywords
Self-efficacy, Self Efficacy, Nurses's Role, Professional Role, Clinical Trial, Breast Feeding
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breastfeeding supportBehavioural

    Also called SIALAC

    Self-efficacy

Study groups in NCT03019484
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Behavioral: Breastfeeding support
Control: Standard CareNo interventionThis 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes on Breastfeeding status reported by mothers

    The mothers reported whether they were breastfeeding or not.

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2017 (estimated)
  2. Study startApr 2014
  3. Primary completionFeb 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03019484
Sponsor's protocol ID
NUR-SIALAC
Acronym
SIALAC
Status last verified
Jan 2017
First submitted
26 Dec 2016
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Breastfeeding support in people with Breast Feeding and Self Efficacy, run by Clinica Universidad de Navarra, Universidad de Navarra at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03019484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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