Clinical trial NCT03019484: Synergy, Self-efficacy, Breastfeeding and Care (SInergia, Autoeficacia, Lactancia y Cuidados)
Official title: A Complex Intervention to Promote Breastfeeding Self-efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Feeding
Self Efficacy
Keywords: Self-efficacy
Self Efficacy
Nurses's Role
Professional Role
Clinical Trial
Breast Feeding
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario de Navarra
name: Universidad Pública de Navarra
First posted: 2017-01-12
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

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)

Primary outcomes:
measure: Changes on Breastfeeding status reported by mothers
timeFrame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth
measure: Changes on maternal breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) questionnaire
timeFrame: at 4 time points: after birth while in hospital (T1); and 4 weeks (T2); 8 weeks (T3); and 6 months (T4) after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Departamento de Ciencias de la Salud. Universidad Pública de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Facultad de Enfermería. Universidad de Navarra
state: Navarra
Study officials:
affiliation: Complejo Hospitalario de Navarra
name: Elena Antoñanzas, MSc,BSc,RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Navarra
name: Olga Lopez-Dicastilo, PhD,MSc,BSc
role: PRINCIPAL_INVESTIGATOR
References: