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

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.

The effect of non-organophosphate household pesticides exposure during pregnancy on infants birth sizes and growth rate: a cohort study

“…This was a prospective cohort study as part of the Breastfeeding Attitude and Volume Optimization (BRAVO) study (NCT01566812) in Jakarta, Indonesia [21].The participant enrollment was performed from June 2012 to January 2017. From 718 participants enrolled in BRAVO study, initially, 282 participants were excluded due to incomplete data on exposure.…”

“…Pregnant women in three centers, i.e., one private maternal and children hospital (Budi Kemuliaan Hospital) and two primary care centers in Senen and Jatinegara districts, Jakarta, Indonesia were recruited for participation in the BRAVO study during their 3rd trimester antenatal care visit. BRAVO was ethically approved by the Institutional Review Board of the Faculty of Medicine Universitas Indonesia/Cipto Mangunkusumo Hospital, Jakarta, Indonesia (reference number: 913/UN2.F1/ETIK/X/ 2012) [21].Informed consent was obtained from all study participants prior to study enrolment [21].…”

“…Maternal characteristics including maternal age, parity, history of abortion, family income, level of education, weight gain during pregnancy (expressed as ΔBMI: the difference between BMI at labor and BMI prior to pregnancy), and alcohol or illicit drug use in pregnancy were obtained from self-report questionnaires filled out by pregnant women at recruitment [21]. Gestational age at delivery, Apgar score, maternal hypertension and diabetes (pre-existing or gestational), certain neonatal morbidities (special nursery care requirements, including sepsis, respiratory distress, and hyperbilirubinemia) were obtained from medical records [21].…”

“…Exposure to household pesticides was obtained by validated self-report questionnaires filled out by the pregnant women at recruitment [21]. Mothers were considered as exposed to household pesticides when they use mosquito insecticides, or other pesticides to eliminate cockroaches or other insects during their pregnancy.…”

“…pesticides used against cockroaches might be more potent than pesticides used against mosquitos. No data on the type or brand of household pesticides was recorded [21]. Exposure to other possible EDCs including water sources, fuel usage at home, and garbage burning were recorded [21].…”