Abstract
BackgroundA growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases. However, evidence on the long-term benefits of breastfeeding is scarce and often conflicting. The BReastfeeding Attitude and Volume Optimization (BRAVO) trial is designed to study the effect of breastfeeding on early signs of later chronic diseases, particularly cardiovascular, respiratory, and metabolic risks later in life. In addition, the effectiveness of breastfeeding empowerment in promoting breastfeeding will also be evaluated.Methods/designThis study is an ongoing randomized trial in Jakarta, Indonesia, that began in July 2012. Pregnant women are being screened for their breastfeeding plan in the third trimester, and those with low intention to breastfeed are randomly allocated to either receiving an add-on breastfeeding-optimization program or usual care. Primary outcomes include breastfeeding rate, lung function, and blood pressure during the first year of life and vascular/cardiac characteristics, which will be measured at the age of 4 to 5 years. Child growth and infection/illness episodes are measured, whereas cognitive testing is planned for the children at 5 years of age.DiscussionTo date, 784 women (80 %) have been randomized of the 1,000 planned, with satisfactory completeness of the 1-year follow up (90.1 %). Included mothers are of lower socioeconomic status and more often have blue-collar jobs, similar to what was observed in the pilot study.Trial registrationClinicalTrials.gov, NCT01566812. Registered on 27 March 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1397-y) contains supplementary material, which is available to authorized users.
Highlights
A growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases
Included mothers are of lower socioeconomic status and more often have blue-collar jobs, similar to what was observed in the pilot study
The largest and probably most informative is a cluster-randomized trial, the Promotion of Breastfeeding Intervention Trial (PROBIT), in over 17,000 women in Belarus, which showed that empowerment raised breastfeeding rates and decreased infant gastrointestinal infection and atopic eczema rates, clearly underpinning short-term benefits [35]
Summary
BRAVO is the first randomized breastfeeding empowerment study that is focused on estimating the early life cardiovascular and cardiometabolic consequences of breastfeeding. A threat to the BRAVO design is that women who are randomly allocated to care as usual will, knowing about the study objectives, change their breastfeeding plans, leaving a smaller contrast between the experimental intervention arms. A cluster-randomized design would have required larger numbers of pregnant women, in whose offspring highly specialized cardiovascular and respiratory measurements were considered unfeasible. A cluster-randomized design bears intrinsic prior uncertainties, such as achieved (differences in) cluster sizes and unknown within-cluster correlations Such variation can be dealt with in analysis, the BRAVO design with individual randomization was considered a priori a more robust approach, concerning its overall aim, the study of cardiovascular and cardiometabolic consequences of breastfeeding.
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