Support Via Online Social Networks to Promote Safe Infant Care Practices

Not Applicable

Recruiting

• Conditions: Infant Death; Breastfeeding; Sudden Infant Death Syndrome Without Mention of Autopsy

• Registration Number: NCT05767658
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-14
• Study Start: 2024-03-01
• Status Verified: 2024-06
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

• Currently enrolled in WIC, 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 regular 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 feeding any breastmilk 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 received a TodaysBaby educational program (randomized to a TodaysBaby program through either the SMARTER, or SUPERSONIC study), either in their current or a previous pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Boston University Medical Campus; 🇺🇸 Boston, Massachusetts, United States