Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
1152 participants
INTERVENTIONAL
2025-09-01
2029-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Control
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.
Usual Care
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.
BEST4Baby
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
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.
Interventions
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BEST4Baby
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
\- 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.
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
KLE University Jawaharlal Nehru Medical College
UNKNOWN
Benten Technologies, Inc.
INDUSTRY
Thomas Jefferson University
OTHER
Responsible Party
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Locations
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KLE Univeristy
Belagavi, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-3092
Identifier Type: -
Identifier Source: org_study_id
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