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01.12.2016 | Study protocol | Ausgabe 1/2016 Open Access

Trials 1/2016

BReastfeeding Attitude and Volume Optimization (BRAVO) trial: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2016
Autoren:
Ary I. Savitri, Nikmah S. Idris, Wahyuni Indawati, Siti Rizny F. Saldi, Dwirani Amelia, Mohammad Baharuddin, Sudigdo Sastroasmoro, Diederick E. Grobbee, Cuno S. P. M. Uiterwaal
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Electronic supplementary material

The online version of this article (doi:10.​1186/​s13063-016-1397-y) contains supplementary material, which is available to authorized users.

Abstract

Background

A 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/design

This 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.

Discussion

To 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 registration

ClinicalTrials.gov, NCT01566812. Registered on 27 March 2012.
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