Breast Feeding, Breastfeeding, Exclusive, Infant Development, Infant Growth
Conditions
Keywords
breastfeeding, India, infant feeding, peer counselors
Brief summary
The proposed project seeks to evaluate the effectiveness and implementation of the Breastfeeding Education Support Tool for Baby (BEST4Baby) intervention, an mHealth-supported community-based peer counselor breastfeeding intervention for mothers in India. Given that rates of optimal infant feeding practices have remained stagnant over the past two decades in India, and that India is the most populous country and icontributes one-fifth of all global live births, this project could have major global health implications if the intervention is found to improve maternal breastfeeding practices and infant clinical outcomes. The project will also provide evidence needed to adopt BEST4Baby nationally and in other low resource communities.
Interventions
BEHAVIORALBEST4Baby
BEST4Baby consists of prenatal and post-delivery breastfeeding education and support for mothers provided by community-based peer counselors who are trained in a modified 5-day WHO/UNICEF Breastfeeding Counselling Course and supported by an mHealth application.
BEHAVIORALUsual Care
Participants in the control clusters will continue with local practice for antenatal breastfeeding support and referral to facilities. It is expected that they will receive routine health education recommended by the national health system during the prenatal and postnatal period and offered through PHC and community level workers, including ASHAs. ASHAs may visit a woman after delivery to provide lactation support, as needed, with visits ceasing at 42 days post-delivery. Breastfeeding mothers requiring advanced lactation support may be referred to a community subcenter for care with more skilled clinicians.
Sponsors
Thomas Jefferson University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
KLE University Jawaharlal Nehru Medical College
Benten Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 18 years of age, * pregnant and 20-27 weeks of gestation at study enrollment, * singleton pregnancy, * no major antepartum complications, * living in a research site, * planning to deliver in the cluster area, * capable of giving informed consent, * willing to be visited by a PC and research personnel for up to 12 months post-delivery.
Exclusion criteria
comorbidities impacting breastfeeding, \- severe psychological illness that could interfere with consent and study participation. Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences: illness or clinical complications warranting prolonged hospitalization, stillbirth, low birth weight (\< 2500 g), congenital abnormality, or neonatal death.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| exclusive breastfeeding at 6 months | 6 months | proportion of infants exclusively breastfed at 6 mo as measured with the infant feeding behavior questionnaire. EBF will be defined as receiving breast milk as the only source of nourishment for the first 6 mo of life, except for oral rehydration solution, vitamins, medicines. |
| Infant growth velocity | 6 months and 12 months | mean change in length from birth to 6 months, and birth to 12 months |
| Infant cognitive development | 12 months | mean Bayley Scales of Infant and Toddler Development cognitive domain scores at 12 months |
Countries
India
Contacts
CONTACTVanessa Short, PhD, MPH
CONTACTParth Lalakia
Outcome results
None listed