None listed
Conditions
Interventions
Intervention1: Intervention Arm: participants in the intervention clusters will receive BEST4Baby, a theory-based, breastfeeding education and support intervention that spans the perinatal period from
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Eligibility
Inclusion criteria
Inclusion criteria: 1) At least 18 years of age 2) Pregnant and having reached 20-27 weeks of gestation at study enrollment 3) Singleton pregnancy with no major antepartum complications 4) Living in a research area site 5) Planning to deliver in the cluster area 6) Capable of giving informed consent 7) Willing to be visited by peer counselors and research personnel for up to 12 months post-delivery
Exclusion criteria
Exclusion criteria: 1) Comorbidities impacting breastfeeding 2) Severe psychological illness that could interfere with consent and study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aim 1 EBF at 6 months: proportion of infants exclusively breastfed at 6 months, 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 month of life, except for oral rehydration solution, vitamins, medicines) Aim 2 Infant growth velocity: mean change in length from birth to 6 months, and birth to 12 month. Length at the 3 day and the 6 month and 12 month study visits will be used Infant cognitive development: mean BSID-IV cognitive domain scores at 12 months. Timepoint: 6 months after delivery, 12 months after delivery | — |
Secondary
| Measure | Time frame |
|---|---|
| Infant feeding behaviors: measured with infant feeding behavior questionnaire Timepoint: 3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery;Maternal infant feeding knowledge, attitudes, and self-efficacy: mean scores on infant feeding knowledge items, the IIFAS, and the BSES-SF at baseline, 6 and 12 months; mean changes in scores from baseline to 6 and 12 months.Timepoint: 3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery;Infant health: measured with infant morbidity questionnaireTimepoint: 3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery;Infant weight: mean change in weight from birth to 6 months, and birth to 12 months. Weight at 3 day, 6 month, and 12 month study visits will be used.Timepoint: 3 days post-delivery, and 2, 4, 6, 8, 10 and 12 months post-delivery;Infant language, motor, social-emotional and adaptive skill development: mean BSID-IV language, motor, social-emotional and adaptive skill domain scores at 12 months.Timepoint: 12 months after delivery | — |
Countries
India
Contacts
Public ContactDr Shivaprasad S Goudar
Jawaharlal Nehru Medical College
Outcome results
None listed