Social Transfers for Exclusive Breastfeeding in Brazil

NCT ID: NCT06157697

Last Updated: 2025-06-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-06

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Feeding, Exclusive Breastfeeding Development, Child Development, Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control Group

Only educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group 1 - Non-Conditional Social Transfer

Educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided. At the baseline visit, participants are told that at the 6-month visit, they will receive a gift of their choice - which is meant to show our appreciation and support for their efforts in breastfeeding.

Intervention: Behavioral: Social Transfer

Group Type EXPERIMENTAL

Social Transfer

Intervention Type BEHAVIORAL

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.

Intervention Group 2 - Conditional Social Transfer

Educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided. At the baseline visit, participants are told that at the 6-month visit, they will receive a gift of their choice if they are still exclusively breastfeeding.

Intervention: Behavioral: Social Transfer

Group Type EXPERIMENTAL

Social Transfer

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role collaborator

University of Basel

OTHER

Sponsor Role collaborator

Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordyn Wallenborn

Role: PRINCIPAL_INVESTIGATOR

Swiss Tropical & Public Health Institute

Locations

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University of Sao Paulo

São Paulo, Butantã, Brazil

Site Status RECRUITING

Federal University of São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jordyn Wallenborn

Role: CONTACT

+41 76 525 01 83

Stephanie Khoury

Role: CONTACT

+41 78 265 20 60

Facility Contacts

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Alexandra Brentani, MD, PhD

Role: primary

Kelly Coca

Role: primary

+55 11 99909 1256

References

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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.

Reference Type DERIVED
PMID: 40991943 (View on PubMed)

Other Identifiers

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steb2

Identifier Type: -

Identifier Source: org_study_id

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