Breast Feeding, ExclusiveSTEBBNCT06157697
Social Transfers for Exclusive Breastfeeding in Brazil
A study testing Social Transfer in people with Breast Feeding, Exclusive and Breastfeeding, run by Swiss Tropical & Public Health Institute at 2 sites in Brazil.
Trial 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. Are social transfers effective at increasing exclusive breastfeeding rates 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Feeding, Exclusive, Breastfeeding, Development, Child
- What is being tested?
- Social Transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesBrazil
- Study dates
- 6 Mar 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Plans to move permanently outside study area
- Has a medical, intellectual or psychological disability
- Contraindication for breastfeeding
- Preterm births
- Children born with < 2500 grams
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of Sao Paulo
São Paulo, Butantã, 05508-220
Federal University of São Paulo
São Paulo, 04021-001
About this study
Official title: Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil
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:
- Are social transfers effective at increasing exclusive breastfeeding rates
- Are social transfers effective in prolonging the duration of exclusive breastfeeding
- Are social transfers effective in prolonging the duration of complementary breastfeeding
- What are the long-term impacts of social transfers for breastfeeding on child health and development
Read more
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.
- Being tested
- Social Transfer
- Keywords
- exclusive breastfeeding, child development, social transfer
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social TransferBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Social Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months postpartum
Secondary outcomes (4)
Child Health Outcomes
We will assess the child's health outcomes by using a questionnaire. The questionnaire will ask a range of yes or no questions about disease/illness history, hospitalizations, and other health events.
Measured: 1 month, 6 months, 1 year, 2 years
Early Childhood Development
When the child is two years of age, a comprehensive end line assessment will be conducted to evaluate early childhood development indicators (e.g. The Global Scale for Early Development (GSED). This indicator will be normalized to a mean of 0 and a standard deviation of 1 to facilitate interpretation of estimated group differences.
Measured: 1 year, 2 years
Prevalence of Complementary Breastfeeding
The proportion of women complementary breastfeeding at 1-year, and 2-years postpartum will be assessed using a questionnaire. Complementary breastfeeding is defined as receipt of human milk in combination with complementary foods and liquid. At each time point 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 complementary breastfeeding status.
Measured: 6 months, 1 year, 2 years
Duration of Complementary Breastfeeding
The duration of complementary breastfeeding at 1-year, and 2-years postpartum will be assessed using a questionnaire. Complementary breastfeeding is defined as receipt of human milk in combination with complementary foods and liquid. At each time point 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 complementary breastfeeding status.
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Mar 2025
- Primary completion19 Jan 2026
- Study completion30 Jun 2026
Why it stopped: The loss of follow-up was too large to justify completing the long-term follow-up of participants. Only the 6-month follow-up was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, University of Basel, Swiss National Science Foundation, Federal University of São Paulo
- Responsible party
- Sponsor
- Investigators
- Jordyn Wallenborn, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157697
- Sponsor's protocol ID
- steb2
- Acronym
- STEBB
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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;21(1):75. doi: 10.1186/s13006-026-00865-2.
PubMed 42321811Khoury 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.
PubMed 40991943
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil
- ClinicalTrials.gov ID
- NCT06157697
- Acronym / sponsor ID
- STEBB / steb2
- Keywords
- exclusive breastfeeding, child development, social transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The loss of follow-up was too large to justify completing the long-term follow-up of participants. Only the 6-month follow-up was completed.
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- University of Sao Paulo, University of Basel, Swiss National Science Foundation, Federal University of São Paulo
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are social transfers effective at increasing exclusive breastfeeding rates
- Are social transfers effective in prolonging the duration of exclusive breastfeeding
- Are social transfers effective in prolonging the duration of complementary breastfeeding
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Social TransferEducational 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 |
| Intervention Group 2 - Conditional Social Transfer | Experimental | Behavioral: Social TransferEducational 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Plans to move permanently outside study area
- Has a medical, intellectual or psychological disability
- Contraindication for breastfeeding
- Preterm births
- Children born with < 2500 grams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social TransferSocial 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. | Behavioural | Intervention Group 1 - Non-Conditional Social Transfer, Intervention Group 2 - Conditional Social Transfer |
Primary outcome
Prevalence of Exclusive Breastfeeding
Time frame: 6 months postpartum
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.
Duration of Exclusive Breastfeeding
Time frame: 6 months postpartum
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.
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: The loss of follow-up was too large to justify completing the long-term follow-up of participants. Only the 6-month follow-up was completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 42321811Khoury 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;21(1):75. doi: 10.1186/s13006-026-00865-2.
- Derived from this study: PubMed 40991943Khoury 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordyn Wallenborn principal investigator
Swiss Tropical & Public Health Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Transfer in people with Breast Feeding, Exclusive and Breastfeeding, run by Swiss Tropical & Public Health Institute at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The loss of follow-up was too large to justify completing the long-term follow-up of participants. Only the 6-month follow-up was completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Exclusive Breastfeeding (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157697, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.