Breastfeeding Education Support Tool
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BEST4Baby, Usual Care.
- Who it may be relevant to
- Registry conditions: Breastfeeding, Exclusive, Infant Development, Infant Growth, Breast Feeding. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral 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. - Behavioral 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 r
Primary outcome measures
- exclusive breastfeeding at 6 months [Time frame: 6 months]
- Infant growth velocity [Time frame: 6 months and 12 months]
- Infant cognitive development [Time frame: 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
India · 1 center
- KLE Univeristy — Belagavi
Identifiers
NCT: NCT06797063 · 2024-3092 · 1R01HD112492