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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
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
Usual care applied in the hospital
Budi Kemuliaan Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Cardiovascular risk
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)
Time frame: 5 years
Breastfeeding habits
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
Time frame: 1 years
Child growth
Body weight, height, head circumference, abdominal circumference
Time frame: 5 years
Lung function
Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry
Time frame: 5 years
Microbiome
Infant nasopharyngeal \& oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture.
Time frame: 1 years
Development
Bayley Infant Scales, IQ
Time frame: 5 years
Illness
Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms
Time frame: 1 year
Inflammation
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Serum hs-CRP, Fibrinogen
Time frame: 1 year