Social Transfers for Exclusive Breastfeeding in Brazil
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSwiss Tropical & Public Health Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Plans to move permanently outside study area
Has a medical, intellectual or psychological disability
Contraindication for breastfeeding
Preterm births
Trial design
Design model
Parallel
Treatments tested in this trial
Social Transfer
BehavioralSocial 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.
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention Group 1 - Non-Conditional Social TransferExperimental treatment 1 intervention
Group C: Intervention Group 2 - Conditional Social TransferExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months postpartum2
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.
Time frame
6 months postpartumSecondary outcomes
1
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.
Time frame
1 month, 6 months, 1 year, 2 years2
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.
Time frame
1 year, 2 years3
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.
Time frame
6 months, 1 year, 2 years4
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.
Time frame
6 months, 1 year, 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Swiss Tropical & Public Health Institute
Lead sponsor
University of Sao Paulo
Collaborator
University of Basel
Collaborator
Swiss National Science Foundation
Collaborator
Federal University of São Paulo
Collaborator
Source ClinicalTrials.gov