Support Via Online Social Networks to Promote Safe Infant Care Practices (SUPERSONIC)

University of Virginia

Status: Enrolling

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

Treatments: Behavioral: Early Brain Development and Parent-Child Relationships; Behavioral: Breastfeeding; Behavioral: Safe Sleep

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05767658

5R01MD007702-07 (U.S. NIH Grant/Contract)

H-43455

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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3,000 participants in 4 patient groups

Safe Sleep

Experimental group

Description:

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

Treatment:

Behavioral: Safe Sleep

Breastfeeding

Experimental group

Description:

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

Treatment:

Behavioral: Breastfeeding

Safe Sleep and Breastfeeding

Experimental group

Description:

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, and b) an online community and social network of other pregnant WIC clients and new parents

Treatment:

Behavioral: Safe Sleep

Behavioral: Breastfeeding

Early Brain Development and Parent -Child Relationships

Active Comparator group

Description:

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.

Treatment:

Behavioral: Early Brain Development and Parent-Child Relationships