BReast Feeding Attitude and Volume Optimization (BRAVO) Trial: A Randomized Breast Feeding Optimization Experiment
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Indonesia University
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Cardiovascular risk
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Exclusion Criteria
- Not provided
Arms & Interventions
Breast feeding optimization
Intervention: Breast feeding optimization (Behavioral)
Breast feeding optimization
Intervention: Usual care (Behavioral)
Usual/routine care
Intervention: Usual care (Behavioral)
Outcomes
Primary Outcomes
Cardiovascular risk
Time Frame: 5 years
Abdominal aortic/carotid intima media thickness, distensibility, elastic modulus; pulse wave velocity, stiffness index, blood pressure; echocardiography: ejection fraction (%), fractional shortening (%), TAPSE (cm), cardiac index (L/min/m2), LV mass (grams)
Breastfeeding habits
Time Frame: 1 years
Breastfeeding practice: Y/N, night/day, frequency (time interval between breastfeeding, e.g 2 hours) Supplementary formula: frequency/day, volume per feeding Complementary feeding: Y/N, type of foods; frequency/day Employer and employee satisfaction
Secondary Outcomes
- Lung function(5 years)
- Child growth(5 years)
- Illness(1 year)
- Microbiome(1 years)
- Development(5 years)
- Inflammation(1 year)
Investigators
Nikmah Salamia Idris
Dr.
Indonesia University