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Starting soon Not applicable

Breastfeeding Education Support Tool

NCT06797063 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-05-05

Condition(s) studied

Breastfeeding, ExclusiveInfant DevelopmentInfant GrowthBreast Feeding

Investigational drug(s) / intervention(s)

BEST4BabyUsual Care

BEST4Baby: 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 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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
KLE Univeristy Belagavi Karnataka
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06797063 on ClinicalTrials.gov ↗ ← All trials in India