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Recruiting NCT06157697

Social Transfers for Exclusive Breastfeeding in Brazil

No phase Interventional Breast Feeding, Exclusive Breastfeeding Development, Child Development, Infant

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: Social Transfer.
Who it may be relevant to
Registry conditions: Breast Feeding, Exclusive, Breastfeeding, Development, Child, Development, Infant. Basic parameters: 18 years — 50 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
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil

Overview

The goal of this study is to assess the effectiveness of social transfers on exclusive breastfeeding rates in São Paulo, Brazil. The main research questions are: 1. Are social transfers effective at increasing exclusive breastfeeding rates 2. Are social transfers effective in prolonging the duration of exclusive breastfeeding 3. Are social transfers effective in prolonging the duration of complementary breastfeeding 4. What are the long-term impacts of social transfers for breastfeeding on child health and development Participants will be randomly assigned to one of three groups: 1) control, no social transfer 2) non-conditional social transfer at 6-months postpartum, and 3) conditional social transfer at six months postpartum; conditional upon the mothers exclusive breastfeeding status. All participants receive education about the benefits of exclusive breastfeeding and current international recommendations. Researchers will compare the intervention groups to the control group to see if social transfers are effective at increasing exclusive breastfeeding rates at six months postpartum.

Interventions

  • Behavioral Social Transfer
    Social transfers are defined as a cash or in-kind transfer. Based on previous social transfer programs in Brazil, we will offer gift packages for mothers at 6 months. The options include: diapers, hygiene products, child developmental toys, transport vouchers, or a combination of these.

Primary outcome measures

  • Prevalence of Exclusive Breastfeeding [Time frame: 6 months postpartum]
  • Duration of Exclusive Breastfeeding [Time frame: 6 months postpartum]
Secondary outcome measures (4)
  • Child Health Outcomes [Time frame: 1 month, 6 months, 1 year, 2 years]
  • Early Childhood Development [Time frame: 1 year, 2 years]
  • Prevalence of Complementary Breastfeeding [Time frame: 6 months, 1 year, 2 years]
  • Duration of Complementary Breastfeeding [Time frame: 6 months, 1 year, 2 years]

Eligibility criteria

Inclusion criteria

  • Gave birth in the last 72 hours
  • Exclusively breastfeeding at time of recruitment and intend to continue to exclusively breastfeed
  • Part of or eligible Bolsa Familia or on the Bolsa Familia list (CAD Unico)
  • Lives in São Paulo
  • No illnesses that contraindicates breastfeeding
  • Had a healthy singleton infant of 37 weeks or more gestation with a birth weight of at least 2500 grams
  • Agrees to participate and sign an informed consent; if under age (12-17 years), a legal representative will also have to agree to sign the informed consent

Exclusion criteria

  • Plans to move permanently outside study area
  • Has a medical, intellectual or psychological disability
  • Contraindication for breastfeeding
  • Preterm births
  • Children born with < 2500 grams

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
Open label
Primary purpose
Other

Study locations

Brazil · 2 centers
  • University of Sao Paulo — São Paulo
  • Federal University of São Paulo — São Paulo

Publications

  • Khoury S, Onofre AC, Sartorio B, Coca K, Costa ML, Karimian-Marnani N, Merten S, Brentani A, Wallenborn J. Barriers to breastfeeding and targeted breastfeeding social transfer programs in Sao Paulo, Brazil: a qualitative study. Int Breastfeed J. 2026 Jun 19. doi: 10.1186/s13006-026-00865-2. Online ahead of print. PMID 42321811
  • Khoury S, Brentani A, Brentani H, Fiamoncini J, Francisco R, Onofre AC, Rodrigues Henrique SE, Fink G, Wallenborn J. Social Transfers for Exclusive Breastfeeding in Brazil: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 24;14:e75796. doi: 10.2196/75796. PMID 40991943

Identifiers

NCT: NCT06157697 · steb2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗