Breastfeeding Education Support Tool

NCT06797063 | Not Yet Recruiting

• 2 other identifiers: 2024-30921R01HD112492
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding, Exclusive; Infant Development; Infant Growth; Breast Feeding

Keywords

breastfeeding; India; infant feeding; peer counselors

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• Infant growth velocity

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

  6 months and 12 months

• Infant cognitive development

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

  12 months

Study Arms (2)

Control

OTHER

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 Indian national health system during the prenatal and postnatal period.

Behavioral: Usual Care

BEST4Baby

EXPERIMENTAL

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.

Behavioral: BEST4Baby

Interventions

BEST4Baby BEHAVIORAL

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.

BEST4Baby

Usual Care BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study focuses on breastfeeding.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• KLE University Jawaharlal Nehru Medical College: collaborator
• Benten Technologies, Inc.: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

KLE Univeristy

Belagavi, Karnataka, 19107, India

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Vanessa Short, PhD, MPH

CONTACT

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

Parth Lalakia

CONTACT

parth.lalakia@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 28, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All de-identified data will be available upon either publication of related work or completion of the project. The data will be available for at least 10 years after the funding period.

Locations

IN (1)