Social Transfers for Exclusive Breastfeeding in Brazil

Breastfeeding Clinical Trial

— STEBB  

Official title:

Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157697
• Other study ID #: steb2
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Swiss Tropical & Public Health Institute
• Contact: Jordyn Wallenborn
• Phone: +41 76 525 01 83
• Email: jordyn.wallenborn[@]swisstph.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Gave birth in the last week

• Exclusively breastfeeding at time of recruitment and intend to continue to exclusively breastfeed

• Part of Bolsa Familia or on the Bolsa Familia list (CAD Unico)

• Lives in São Paulo in the Butantã Jaguaré district

• 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

Related Conditions & MeSH terms

• Breast Feeding, Exclusive
• Breastfeeding
• Development, Child
• Development, Infant

Intervention

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 42 USD would fairly subsidize women's breastfeeding efforts. Therefore, all social transfer options equate to approximately 42 USD. The options include: diapers, child developmental toys, cash, or a combination of these.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo	Butantã

Sponsors (4)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Swiss National Science Foundation, University of Basel, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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