Effectiveness of a new approach for exclusive breastfeeding counselling on breastfeeding prevalence, infant growth velocity and postpartum weight loss in overweight or obese women: Protocol for a randomized controlled trial

Background: Maternal overweight, infant feeding and early growth velocity are risk factors for obesity later in life. The first one thousand days are a window of opportunity to program health and disease. Exclusive breastfeeding may protect against obesity; however, it is not consistently practiced. Obesity rates have been increasing worldwide. Overweight or obese women have lower rates of breastfeeding and face mechanical, psychological and biological difficulties. Breastfeeding counselling is a successful strategy to support breastfeeding in normal weight women; but there is a lack of evidence on its effectiveness in overweight women. Our purpose is to evaluate a new approach to exclusive breastfeeding counselling based on Carl Rogers' Centred-Client Theory in overweight women, and to examine effects on breastfeeding prevalence, infant growth velocity and maternal postpartum weight loss. Methods: A two-arm simple randomized controlled trial will be conducted in overweight and obese women recruited in a Baby Friendly Hospital in Bogotá, Colombia. The intervention is exclusive breastfeeding counselling based on Rogers' theory but adapted for overweight women; it will be performed during the last month of pregnancy, 24 h after delivery and during early infancy (1 and 3 months postpartum). The primary outcomes will be exclusive breastfeeding prevalence, infant growth velocity and maternal weight loss from birth up to 4 months after delivery; and the secondary outcomes will be prolactin and macronutrient levels in breast milk and serum prolactin levels. Intention to treat analysis will be performed to estimate the effect of the new counselling approach compared to standard management on the prevalence of exclusive breastfeeding, infant growth velocity and maternal weight loss. Discussion: We hypothesize that the intervention will result in an increase in the initiation and maintenance of exclusive breastfeeding, allowing adequate infant growth velocity and maternal weight loss after delivery. It is hoped that the results of this trial will provide evidence to support public health policy on supporting breastfeeding in this vulnerable group of women. Trial registration: (UTN) U1111-1228-9913 February 20th 2019; ISRCTN15922904 February 27th 2019, retrospectively registered.