Recruiting

Observational StudySupport Via Online Social Networks to Promote Safe Infant Care Practices

Sponsor:

University of Virginia

Code:

NCT05767658

Conditions

Breastfeeding

Infant Death

Sudden Infant Death Syndrome Without Mention of Autopsy

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Safe Sleep

Breastfeeding

Early Brain Development and Parent-Child Relationships

Study Details

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.

Conditions

Breastfeeding

Infant Death

Sudden Infant Death Syndrome Without Mention of Autopsy

Study ID

NCT05767658

Start date

Mar 1, 2024

Status verified date

Jan, 2026

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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

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

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

active comparator: 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.

Interventions

Safe Sleep

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.

Primary outcome measure

Exclusive infant supine sleep position in the previous two weeks [ Time Frame: Between 2 and 6 months ]
Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks [ Time Frame: Between 2 and 6 months ]
Soft bedding use in the previous two weeks [ Time Frame: Between 2 and 6 months ]
Breastmilk feeding in the previous two weeks [ Time Frame: Between 2 and 6 months ]

Central Contacts and Locations

Central contacts

Katherine Boguszewski, MA

434-243-9663 Keb5un@uvahealth.org

Locations

Boston University Medical Campus

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Katherine Boguszewski, MA

617-206-6269 kbogusze@bu.edu

More Information

Sponsor

University of Virginia

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

Safe Sleep
Breastfeeding
Social Media

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-01-12.