Social Transfers for Exclusive Breastfeeding in Brazil

Not Applicable

Recruiting

• Conditions: Development, Child; Breast Feeding, Exclusive; Development, Infant; Breastfeeding

• Registration Number: NCT06157697
• Lead Sponsor: Swiss Tropical & Public Health Institute

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. 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

Not available

Study Timeline

• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-06
• Status Verified: 2024-09
• Study Start: 2025-03-06
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2025-12
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of Exclusive Breastfeeding	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	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.

Secondary Outcome Measures

Name	Time	Method
Early Childhood Development	1 year, 2 years	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.
Prevalence of Complementary Breastfeeding	6 months, 1 year, 2 years	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.
Child Health Outcomes	1 month, 6 months, 1 year, 2 years	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.
Duration of Complementary Breastfeeding	6 months, 1 year, 2 years	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.

Trial Locations

Locations (2)

University of Sao Paulo; 🇧🇷 São Paulo, Butantã, Brazil

Federal University of São Paulo; 🇧🇷 São Paulo, Brazil