Health TrialsbyHealthPanel

Breastfeeding Education Support Tool

ConditionsBreastfeeding, ExclusiveInfant DevelopmentInfant GrowthBreast Feeding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

at least 18 years of age,

pregnant and 20-27 weeks of gestation at study enrollment,

singleton pregnancy,

no major antepartum complications,

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

336 Participants
are divided into 2 treatment groups
Group A: ControlOther 1 intervention
Group B: BEST4BabyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

Infant growth velocity

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

Time frame
6 months and 12 months
3

Infant cognitive development

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

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Jefferson University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

KLE University Jawaharlal Nehru Medical College

Collaborator

Benten Technologies, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: