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

Sponsor

University of Virginia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05767658

Collaborator

Boston University (Other), Washington University School of Medicine (Other), Boston Medical Center (Other), University of Kentucky (Other), National Institute on Minority Health and Health Disparities (NIMHD) (NIH)

3,000

Enrollment

Arms

32.1

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Infant Death Syndrome (SIDS) Sudden Unexplained Infant Death (SUID) Breastfeeding	Behavioral: Safe Sleep Behavioral: Breastfeeding Behavioral: Safe Sleep and Breastfeeding Behavioral: Early Brain Development and Parent-Child Relationships	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Safe Sleep	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.
Experimental: Breastfeeding	Behavioral: 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.
Experimental: Safe Sleep and Breastfeeding	Behavioral: Safe Sleep and 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 infant safe sleep and breastfeeding (combined intervention) b) an online community and social network of other pregnant WIC clients and new parents.
Active Comparator: Early Brain Development and Parent -Child Relationships	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Infant sleep position in the previous two weeks [Between 2 and 6 months]
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.
Infant sleep location in the previous two weeks [Between 2 and 6 months]
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.
Soft bedding use in the previous two weeks [Between 2 and 6 months]
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.
Pacifier use in the previous two weeks [Between 2 and 6 months]
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.
Breastmilk feeding in the previous two weeks [Between 2 and 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Must be enrolled (or in process of enrolling) at a participating WIC center
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.