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NCT Number: NCT06797063

Breastfeeding Education Support Tool

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. exclusive breastfeeding at 6 months

    Time frame: 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.

  2. Infant growth velocity

    Time frame: 6 months and 12 months

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

  3. Infant cognitive development

    Time frame: 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Parth Lalakia

CONTACT

[email protected]

Vanessa Short, PhD, MPH

CONTACT

[email protected]

412-352-1226

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

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

Registry information

Acronym: BEST4Baby

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 28, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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