Breast Feeding, Cardiovascular Diseases
Conditions
Keywords
Breast Feeding, Cardiovascular Risk
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.
Interventions
BEHAVIORALBreast 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
BEHAVIORALUsual care
Usual care applied in the hospital
Sponsors
CEEBM
Julius Center
Budi Kemuliaan Hospital
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular risk | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Microbiome | 1 years | Infant nasopharyngeal & oral flora, digestive tract/feces flora, maternal oropharyngeal evaluated using PCR and culture. |
| Development | 5 years | Bayley Infant Scales, IQ |
| Child growth | 5 years | Body weight, height, head circumference, abdominal circumference |
| Inflammation | 1 year | Serum hs-CRP, Fibrinogen |
| Illness | 1 year | Infection/fever, allergic symptoms, wheezing, upper/lower respiratory disease, gastrointestinal symptoms |
| Lung function | 5 years | Resistance, compliance, time constant, FVC (liters), FEV1 (liters) measured by spirometry |
Countries
Indonesia
Outcome results
None listed