Breastfeeding Education Support Tool (BEST4Baby)

Thomas Jefferson University

Status: Not yet enrolling

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

Treatments: Behavioral: BEST4Baby; Behavioral: Usual Care

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06797063

2024-3092

1R01HD112492 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,152 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,152 participants in 2 patient groups

Control

Other group

Description:

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.

Treatment:

Behavioral: Usual Care

BEST4Baby

Experimental group

Description:

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.

Treatment:

Behavioral: BEST4Baby