Clinical trial NCT06157697: Social Transfers for Exclusive Breastfeeding in Brazil
Official title: Social Transfers for Exclusive Breastfeeding in São Paulo, Brazil
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Feeding, Exclusive
Breastfeeding
Development, Child
Development, Infant
Keywords: exclusive breastfeeding
child development
social transfer
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: University of Basel
name: Swiss National Science Foundation
First posted: 2023-12-06
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* Gave birth in the last 72 hours
* 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 area
* 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

Primary outcomes:
measure: Prevalence of Exclusive Breastfeeding
timeFrame: 6 months postpartum
measure: Duration of Exclusive Breastfeeding
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Child Health Outcomes
timeFrame: 1 month, 6 months, 1 year, 2 years
measure: Early Childhood Development
timeFrame: 1 year, 2 years
measure: Prevalence of Complementary Breastfeeding
timeFrame: 6 months, 1 year, 2 years
measure: Duration of Complementary Breastfeeding
timeFrame: 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Butantã
Study officials:
affiliation: Swiss Tropical & Public Health Institute
name: Jordyn Wallenborn
role: PRINCIPAL_INVESTIGATOR
References: