Breastfeeding Education Support Tool

Not Applicable

Not yet recruiting

• Conditions: Breastfeeding, Exclusive; Infant Development; Infant Growth; Breast Feeding

• Registration Number: NCT06797063
• Lead Sponsor: Thomas Jefferson University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Study Start: 2025-09-01
• Primary Completion: 2029-09-01
• Study Completion: 2029-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1152

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

KLE Univeristy; 🇮🇳 Belgaum, Karnataka, India