Breastfeeding Education Support Tool

N/ANot Yet RecruitingNCT06797063

Thomas Jefferson University1,152 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,152

Conditions

Breastfeeding, Exclusive Infant Development Infant Growth Breast Feeding

Interventions

BEST4BabyBEHAVIORAL

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.

Usual CareBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

exclusive breastfeeding at 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.

Time frame: 6 months

Infant growth velocity

mean change in length from birth to 6 months, and birth to 12 months

Time frame: 6 months and 12 months

Infant cognitive development

mean Bayley Scales of Infant and Toddler Development cognitive domain scores at 12 months

Time frame: 12 months

Central Contacts

Vanessa Short, PhD, MPH

CONTACT

412-352-1226 vanessa.short@jefferson.edu

Parth Lalakia