Effect of Mobile-Based Counselling on Breastfeeding in Spain: A Randomized Controlled Trial Protocol (COMLACT Study)

Purpose: The primary aim of this study is to determine the influence of an intervention in women based on a free mobile application (LactApp(®), Barcelona, Spain) in maintaining breastfeeding (BF) up to 6 months postpartum. The secondary aim is to assess the effect of health literacy (HL) on breastfeeding duration. Methods: A multicenter, randomized controlled clinical trial of parallel groups will be carried out. Women will be randomly assigned to each of the parallel groups. In the control group, usual clinical practice will be followed from the third trimester of pregnancy to promote BF. In the intervention group, and in addition to usual clinical practice, the women will use a free mobile application (LactApp(®)) from the third trimester to 6 months postpartum. The type of BF at birth, at 15 days and at 3 and 6 months postpartum and the causes of cessation of BF in both groups will be monitored. The hypothesis will be tested using inferential analysis, considering an alpha of 5%. The study protocol was approved by the Clinical Research Ethics Committee of Hospital de la Ribera (Alzira, Valencia, Spain) in February 2021. A per protocol analysis and an intention-to-treat analysis will be performed. Discussion: This study will identify the influence of a mobile application on improving BF rates. If the application proves effective, we will have a tool with free information available to any user at any time of day, which may be complemented by normal clinical practice and be integrated into our health care system. Trial registration: ClinicalTrials.gov ID: NCT05432700.