NCT01566812

Effect of Breastfeeding Optimization on Early Vascular Development

BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This study aims to find out whether breast feeding optimization will increase breast feeding rates and to evaluate its effect on cardiovascular risk and general health of children.

Detailed description

Breast feeding is suggested to give many benefits for babies and there are some initial prove that it might affect their future health, including the development of cardiovascular diseases. In Indonesia, breast feeding rates are very low, while there is a strong upsurge of cardiovascular disease. In this study, we propose to randomly allocate pregnant Indonesian women who plan to give breast feeding for no more than two months, to either care as usual or to a breast feeding empowerment program lasting to 6 months post partum. At the age of one year, all randomized offspring will undergo non-invasive echographic aortic vascular measurements and cardiovascular risk profiling. Measurements for assessing children's general health status will also be performed, including growth monitoring, repeated lung function test, and microbiomic sampling.

Conditions

• Breast Feeding
• Cardiovascular Diseases

Interventions

Type	Name	Description
BEHAVIORAL	Breast feeding optimization	Breast feeding optimization program extends from late pregnancy period to 6 months after birth. Prenatal intervention consists of individual and group counseling/education; perinatal intervention consists of in-hospital lactation support; postnatal intervention consists of home visit, counseling session, reminding telephone call and bulk SMS, special counseling for working mothers, breast pump rental, occupational-related support
BEHAVIORAL	Usual care	Usual care applied in the hospital

Timeline

• Start date: 2012-06-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2012-03-29
• Last updated: 2017-03-07

Locations

1 site across 1 country: Indonesia