Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 16, 2025
Open Peer Review Period: Apr 17, 2025 - Jun 12, 2025
Date Accepted: Aug 31, 2025
(closed for review but you can still tweet)
Study Protocol: Social Transfers for Exclusive Breastfeeding in Brazil (STEBB) Randomized Control Trial
ABSTRACT
Background:
According to the World Health Organization (WHO)’s infant and young child feeding (IYCF) guidelines, infants should be exclusively breastfed for the first 6 months of life. Despite public health campaigns to increase exclusive breastfeeding (EBF) rates, socioeconomic inequities persist among low-income breastfeeding mothers, especially in countries with large wealth and health gaps, such as Brazil. Social transfer programs could help to reduce these gaps, increasing EBF rates while addressing the economic and financial burden that breastfeeding mothers face.
Objective:
The aim of the project is to implement a randomized control trial (RCT) to assess whether conditional and unconditional social transfers can improve EBF rates at 6-months postpartum for mothers in low-income communities in São Paulo, Brazil.
Methods:
: A prospective, randomized control trial will be conducted among 400 mothers who gave birth in the last week and who plan to exclusively breastfeed. Participants will be recruited at the University Hospital from the University of São Paulo. Participants will be randomly assigned to one of the following groups: 1) control group, no social transfer; 2) intervention group one, an unconditional social transfer at 6 months postpartum; and 3) intervention group two, a social transfer at 6 months postpartum conditional upon mothers exclusively breastfeeding. All groups will receive educational materials supporting mothers to exclusively breastfeed. The study will have visits at birth, 1 month, 6 months, 1 year, and 2 years and will include a questionnaire and biological collections of breastmilk samples, infant fecal samples, and blood samples (finger pricks) from both the mother and infant.
Results:
Recruitment for the study began on March 6, 2024. As of now, we have enrolled 18 participants. Our goal is to recruit a total of 400 mother-infant dyads by October 2025, with all study visits expected to be completed by October 2027.
Conclusions:
The Social Transfers for Exclusive Breastfeeding in Brazil (STEBB) intervention is based on a similar program implemented in Vientiane, Lao People’s Democratic Republic, which was highly effective in improving both rates of EBF at 6-month and overall EBF duration. We hypothesize that it will have the same positive effect among mothers in São Paulo, Brazil. If STEBB is successful, there will be potential to work with the Ministry of Health to improve the existing social transfer program for new mothers. Clinical Trial: The RCT was registered on ClinicalTrial.gov on December 6, 2023 (NCT06157697); https://clinicaltrials.gov/study/NCT06157697?term=STEBB&rank=1
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