NCT Number: NCT06157697
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.
Interested in participating?
Request Info18 year–50 year
Female
Interventional
Not applicable
University of Sao Paulo, São Paulo, Butantã, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Jordyn Wallenborn
CONTACT
Stephanie Khoury
CONTACT
Swiss Tropical & Public Health Institute
Other
Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil
Acronym: STEBB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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