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

Study Overview
=================
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.

Official Title
-----------------
A Complex Intervention to Promote Breastfeeding Self-efficacy

Conditions
-----------------
Breast Feeding, Self Efficacy

Intervention / Treatment
-----------------
* Behavioral: Breastfeeding support


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Self-efficacy<br>* Other names: SIALAC;|
| No Intervention: Control: Standard Care<br>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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Self-efficacy, Self Efficacy, Nurses's Role, Professional Role, Clinical Trial, Breast Feeding