A randomized controlled trial to evaluate the effectiveness of a brief motivational intervention to improve exclusive breastfeeding rates: Study protocol

Aims To estimate the effectiveness of a brief motivational intervention (BMI) in increasing the duration of exclusive breastfeeding in the first 6 months postpartum. A complementary aim was to examine a potential mediating role of breastfeeding self-efficacy in the effectiveness of the BMI. Background Breastfeeding is associated with benefits for babies and mothers' health. Among the pool of techniques used to encourage healthy behaviours, BMI is highlighted based on the principles of motivational interviewing. One of the main components of these interventions is the promotion of self-efficacy, which, in fact, is a key factor for breastfeeding success. Design A multi-centre randomized controlled clinical trial of parallel groups. Methods Women who begin to breastfeed in the first hour after birth will be randomly assigned to the intervention group (receiving a BMI at immediate postpartum plus a telephone booster at the 1st and 3rd month postpartum) or the control group (receiving standard breastfeeding education at the same time). Outcome measures include the following: breastfeeding, breastfeeding self-efficacy, general self-efficacy, and postnatal depression. Data will be collected before the intervention and at the 1st, 3rd, and 6th month after birth. The study protocol has been approved by Badajoz Ethics Committee of Clinical Research in October 2017. Discussion This study will identify the effectiveness of BMI in improving exclusive breastfeeding rates. The findings will give useful evidence to health professionals about how to support breastfeeding. Impact This study will address the low-exclusive breastfeeding rates, that in our country are far lower than World Health Organization's recommendation.