Evaluation of the impact of breastfeeding support groups in primary health CENTRES in Andalusia, Spain: a study protocol for a cluster randomized controlled trial (GALMA project)

BACKGROUND: In 2003, the World Health Organization recommended exclusive breastfeeding (EB) during the newborn’s first 6 months of life and, if possible, during the first 2 years. However, EB rates resist these recommendations. In developed countries, only 1 out of 3 babies is breastfed during its first 6 months of life, and great differences between areas and countries can be observed. Only 35% of the newborns receive breastfeeding at 3–4 months of age. There are diverse strategies described in the literature that have proven their efficiency in improving breastfeeding rates. It has also been proven that professional support is an effective tool to extend any kind of breastfeeding; besides, it has been observed that mother-to-mother support also increases breastfeeding initiation, sustainment, and exclusive duration. The overall aim of the study is to assess the impact of the support groups on the sustainment of exclusive breastfeeding until 6 months after birth. METHODS/DESIGN: This study is a cluster-random multicentric clinical trial with a control group and an intervention group, without blinding because it is impossible to mask the intervention. A randomization by centres of primary health (clusters) will be carried out. The women allocated to the intervention or control group will be randomized with a simple randomization sampling. The participants’ breastfeeding rate will be followed up at the first 10 days, and at 2, 4, and 6 months of their newborn’s life. DISCUSSION: There is a need to assess the impact of mother support groups on exclusive breastfeeding. This study aims to analyse the outcomes related to the support received and to identify what should the structure of these groups be; in other words, to describe factors related to a better breastfeeding experience in order to help women increase breastfeeding rates. TRIAL REGISTRATION: The trial is prospectively recorded at the ISRCTN registry (Trial ID: ISRCTN17263529). Date recorded: 17/06/2020.