NCT06157697

Brief Summary

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. 1.Are social transfers effective at increasing exclusive breastfeeding rates
  2. 2.Are social transfers effective in prolonging the duration of exclusive breastfeeding
  3. 3.Are social transfers effective in prolonging the duration of complementary breastfeeding
  4. 4.What are the long-term impacts of social transfers for breastfeeding on child health and development

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Mar 2025Oct 2027

First Submitted

Initial submission to the registry

November 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Expected
Last Updated

June 24, 2025

Status Verified

September 1, 2024

Enrollment Period

9 months

First QC Date

November 27, 2023

Last Update Submit

June 18, 2025

Conditions

Breast Feeding, ExclusiveBreastfeedingDevelopment, ChildDevelopment, Infant

Keywords

exclusive breastfeedingchild developmentsocial transfer

Outcome Measures

Primary Outcomes (2)

  • Prevalence of Exclusive Breastfeeding

    The proportion of women exclusively breastfeeding at 6-months postpartum will be assessed using a questionnaire. Exclusive breastfeeding is defined as receipt of only human milk - which is consistent with the World Health Organization guidelines. At six months postpartum, mothers are asked if they are still currently breastfeeding. If they answer yes, a follow-up question on if they provided any other liquids, solids, or supplements to their child to determine the exclusive breastfeeding status.

    6 months postpartum

  • Duration of Exclusive Breastfeeding

    The duration of exclusive breastfeeding will be assessed using a questionnaire. Exclusive breastfeeding is defined as receipt of only human milk - which is consistent with the World Health Organization guidelines. At six months postpartum, mothers are asked if they are still currently breastfeeding. If they answer yes, a follow-up question on if they provided any other liquids, solids, or supplements to their child to determine the exclusive breastfeeding status.

    6 months postpartum

Secondary Outcomes (4)

  • Child Health Outcomes

    1 month, 6 months, 1 year, 2 years

  • Early Childhood Development

    1 year, 2 years

  • Prevalence of Complementary Breastfeeding

    6 months, 1 year, 2 years

  • Duration of Complementary Breastfeeding

    6 months, 1 year, 2 years

Study Arms (3)

Control Group

NO INTERVENTION

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

Intervention Group 1 - Non-Conditional Social Transfer

EXPERIMENTAL

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

Behavioral: Social Transfer

Intervention Group 2 - Conditional Social Transfer

EXPERIMENTAL

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

Behavioral: Social Transfer

Interventions

Social TransferBEHAVIORAL

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 1 - Non-Conditional Social TransferIntervention Group 2 - Conditional Social Transfer

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Sao Paulo

São Paulo, Butantã, 05508-220, Brazil

RECRUITING

Federal University of São Paulo

São Paulo, 04021-001, Brazil

RECRUITING

Related Publications (1)

  • 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: 40991943DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Jordyn Wallenborn

    Swiss Tropical & Public Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordyn Wallenborn

CONTACT

+41 76 525 01 83jordyn.wallenborn@swisstph.ch

Stephanie Khoury

CONTACT

+41 78 265 20 60stephanie.khoury@swisstph.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 6, 2023

Study Start

March 6, 2025

Primary Completion

December 1, 2025

Study Completion (Estimated)

October 1, 2027

Last Updated

June 24, 2025

Record last verified: 2024-09

Locations

BR(2)