Support Via Online Social Networks to Promote Safe Infant Care Practices

Breastfeeding Clinical Trial

— SUPERSONIC  

Official title:

Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767658
• Other study ID #: H-43455
• Secondary ID: 5R01MD007702-07
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: January 2026

Study information

• Verified date: March 2024
• Source: University of Virginia
• Contact: Nicole Geller, MPH
• Phone: 617-206-6269
• Email: nls[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to improve adherence to American Academy of Pediatrics safe sleep (SS) recommendations and improve rates of initiation and duration of partial and exclusive breastfeeding (BF); and reduce Black/White disparities in these practices through the use of private Facebook groups providing a) evidence-based education through videos and other multi-media supporting best practices and b) an online community and social network of other pregnant WIC clients and new parents.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently enrolled in WIC, TANF, EBT, or SNAP; or it not, then have either Medicaid or no health insurance
• Must be English speaking
• Must be pregnant and less than 30 weeks gestation
• Must live in the United States
• Must have daily access to Facebook and short message service (SMS) texting (mobile phone)

Exclusion Criteria:

• Not planning to live in same home as infant after birth.
• Prenatal diagnosis expected to impact on infant care practices in a manner not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning.
• Known or reported mental health or other issues that would preclude custody of the infant or being able to participate in the informed consent process.
• Meets the definition of a minor according to applicable state law.
• Participants who consent to participation in the study, must complete the Agile Onboarding process before they reach 30+0 weeks gestation.
• Currently or previously enrolled in another TodaysBaby educational program and study (SMART, SMARTER, or SUPERSONIC), either in their current or a previous pregnancy

Related Conditions & MeSH terms

• Breastfeeding
• Death
• Infant Death
• Sudden Infant Death

Intervention

Behavioral:
• Safe Sleep
Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for infant safe sleep and b) an online community and social network of other pregnant WIC clients and new parents.
• Breastfeeding
Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for breastfeeding and b) an online community and social network of other pregnant WIC clients and new parents.
• Early Brain Development and Parent-Child Relationships
Participants will be part of a private Facebook group from approximately 32 weeks gestation to 6 months postpartum. The Facebook group will provide a) evidence-based education through videos and other multi-media supporting best practices for early brain development and parent-child interactions (control intervention) and b) an online community and social network of other pregnant WIC clients and new parents.

Locations

Country	Name	City	State
United States	Boston University Medical Campus	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
University of Virginia	Boston Medical Center, Boston University, National Institute on Minority Health and Health Disparities (NIMHD), University of Kentucky, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant sleep position in the previous two weeks	An investigator-developed maternal survey will be used to assess infant's usual sleep position during the previous two weeks with categorical responses of back, stomach, side, and other.	Between 2 and 6 months
Primary	Infant sleep location in the previous two weeks	An investigator-developed maternal survey will be used to assess the infant's usual sleep location during the previous two weeks with categorical responses of room sharing without bed sharing, room sharing with bed sharing, no room sharing and no bed sharing.	Between 2 and 6 months
Primary	Soft bedding use in the previous two weeks	An investigator-developed maternal survey will be used to assess soft bedding placed in and around the infant (while sleeping) during the previous two weeks with categorical responses of Yes or No.	Between 2 and 6 months
Primary	Pacifier use in the previous two weeks	An investigator-developed maternal survey will be used to assess the infant's pacifier use during the previous two weeks with categorical responses of Yes or No.	Between 2 and 6 months
Primary	Breastmilk feeding in the previous two weeks	An investigator-developed maternal survey will be used to assess whether the infant was breast fed during the previous two weeks with categorical responses of exclusively breast fed, partially breast fed, or not breast fed.	Between 2 and 6 months