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Effect of Breastfeeding Optimization on Early Vascular Development (BRAVO)

U

University of Indonesia (UI)

Status

Unknown

Conditions

Breast Feeding
Cardiovascular Diseases

Treatments

Behavioral: Breast feeding optimization
Behavioral: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT01566812
BRAVO_trial

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,000 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

  • Plan to breast feed for ≤2 months
  • Residing in vicinity ≤ 5 km from the hospital/agree to comply to health visit schedule
  • Telephone communication is possible
  • No known HIV or active tuberculosis in mother
  • Uncomplicated pregnancy

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,000 participants in 2 patient groups

Breast feeding optimization
Experimental group
Treatment:
Behavioral: Usual care
Behavioral: Breast feeding optimization
Usual/routine care
Active Comparator group
Treatment:
Behavioral: Usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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