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

Self Efficacy Clinical Trial

— SIALAC  

Official title:

A Complex Intervention to Promote Breastfeeding Self-efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019484
• Other study ID #: NUR-SIALAC
• Status: Completed
• Phase: N/A
• First received: December 26, 2016
• Last updated: January 10, 2017
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2017
• Source: Clinica Universidad de Navarra, Universidad de Navarra
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Breast Feeding
• Self Efficacy

Intervention

Behavioral:
• Breastfeeding support
Self-efficacy

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Departamento de Ciencias de la Salud. Universidad Pública de Navarra	Pamplona	Navarra
Spain	Facultad de Enfermería. Universidad de Navarra	Pamplona	Navarra

Sponsors (3)

Lead Sponsor	Collaborator
Clinica Universidad de Navarra, Universidad de Navarra	Complejo Hospitalario de Navarra, Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No