Social Transfers for Exclusive Breastfeeding in Brazil (STEBB)

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:

1. Are social transfers effective at increasing exclusive breastfeeding rates
2. Are social transfers effective in prolonging the duration of exclusive breastfeeding
3. 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 Overview

• Status: Not yet recruiting
• Conditions: Development, Infant; Breastfeeding; Development, Child; Breast Feeding, Exclusive
• Intervention / Treatment: Behavioral: Social Transfer

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordyn Wallenborn; Phone Number: +41 76 525 01 83; Email: jordyn.wallenborn@swisstph.ch
• Study Contact Backup: Name: Stephanie Khoury; Phone Number: +41 78 265 20 60; Email: stephanie.khoury@swisstph.ch

Study Locations

• Brazil
  • Butantã
    • São Paulo, Butantã, Brazil, 05508-220
      • University of Sao Paulo
      • Contact: Alexandra Brentani, MD, PhD; Email: alexandra@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Given birth in the last four weeks
• Exclusively breastfeeding at time of recruitment
• Lives in São Paulo in the Butantã Jaguaré district
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Only educational materials focused on the benefits of exclusive breastfeeding and the current international recommendations are provided.
Experimental: 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	Behavioral: Social Transfer; Social transfers are defined as a cash or in-kind transfer. Based on the monthly minimum wage in Brazil and an estimated 15 full working days needed to exclusively breastfeed over a 6-month period, a social transfer of approximately 100 USD would fairly subsidize women's breastfeeding efforts. Therefore, all social transfer options equate to approximately 100 USD. The options include: diapers, child developmental toys, cash, or a combination of these.
Experimental: 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	Behavioral: Social Transfer; Social transfers are defined as a cash or in-kind transfer. Based on the monthly minimum wage in Brazil and an estimated 15 full working days needed to exclusively breastfeed over a 6-month period, a social transfer of approximately 100 USD would fairly subsidize women's breastfeeding efforts. Therefore, all social transfer options equate to approximately 100 USD. The options include: diapers, child developmental toys, cash, or a combination of these.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prevalence of Complementary Breastfeeding	The proportion of women complementary breastfeeding at 6-months 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.	6 months postpartum
Duration of Complementary Breastfeeding	The duration complementary breastfeeding at 6-months 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.	6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother and Child Anemia Levels	We will assess the mother and child anemia levels. The HemoCue Hb 301 will be used to give an instant measurement of the Haemoglobin (Hb) level of the patient. Capillary blood will be collected through a finger prick. Blood samples drawn for the haemoglobin assessment will be discarded after the test. Iron levels will be analyzed as a continuous outcome.	1 month, 6 months, 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.	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.	1 year, 2 years
Infant Anthropometric Measurements	Infants will be measured for length, weight, head circumference, skinfold thickness. Height will be measured in centimeters by using a Height Measuring Device, stadiometer, 20-205cm. Weight will be measured in kilograms by a mobile weighing scale. Skin fold measurements will be collected using a skin fold caliper. Head, waist, and hip measurements and Mid-upper arm circumference (MUAC) will be measured using non-stretchable measuring tape. All measurements will be analyzed as age standardized z-scores.	1 month, 6 months, 1 year, 2 years
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.	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.	1 year, 2 years
Maternal Anthropometric Measurements	We will measure the mothers height (meters) and weight (kilograms) in order to calculate the body mass index (kg/m2).	1 month, 6 months, 1 year, 2 years
Maternal Mental Health Outcomes	The mothers mental health will be assessed using a standardized questionnaire (Edinburgh Postnatal Depression Scale (EPDS)). The score ranges from 0 to 30, 0 being none to minimal depression and 30 being severe depression.	1 month, 6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Swiss National Science Foundation; University of Sao Paulo; University of Basel
• Investigators: Principal Investigator: Jordyn Wallenborn, Swiss Tropical & Public Health Institute

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: child development; exclusive breastfeeding; social transfer
• Other Study ID Numbers: steb2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No