NCT03019484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

10 months

First QC Date

December 26, 2016

Last Update Submit

January 10, 2017

Conditions

Breast FeedingSelf Efficacy

Keywords

Self-efficacySelf EfficacyNurses's RoleProfessional RoleClinical TrialBreast Feeding

Outcome Measures

Primary Outcomes (2)

  • Changes on Breastfeeding status reported by mothers

    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

    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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control: Standard Care

NO INTERVENTION

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.

Interventions

Breastfeeding supportBEHAVIORAL

Self-efficacy

Also known as: SIALAC
Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain

Location

Departamento de Ciencias de la Salud. Universidad Pública de Navarra

Pamplona, Navarre, 31008, Spain

Location

Facultad de Enfermería. Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Elena Antoñanzas, MSc,BSc,RN

    Complejo Hospitalario de Navarra

    PRINCIPAL INVESTIGATOR

  • Olga Lopez-Dicastilo, PhD,MSc,BSc

    University of Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 26, 2016

First Posted

January 12, 2017

Study Start

April 1, 2014

Primary Completion

February 1, 2015

Study Completion

November 1, 2015

Last Updated

January 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(4)