Support Via Online Social Networks to Promote Safe Infant Care Practices

NCT05767658 | Recruiting

• 2 other identifiers: H-434555R01MD007702-07
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

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

Keywords

Safe Sleep; Breastfeeding; Social Media

Outcome Measures

Primary Outcomes (4)

• Exclusive infant supine 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, with the proportion of infants using exclusive supine sleep position as the primary outcome measure.

  Between 2 and 6 months

• Infant sleep location (exclusive room sharing without bed sharing) 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, with the proportion of infants exclusively room sharing without bed sharing as the primary outcome measure.

  Between 2 and 6 months

• 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

• 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

Secondary Outcomes (3)

• Usual infant sleep position in the previous two weeks

  Between 2 and 6 months

• . Usual infant sleep location in the previous two weeks

  Between 2 and 6 months

• Pacifier use in the previous two weeks

  Between 2 and 6 months

Study Arms (4)

Safe Sleep

EXPERIMENTAL

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

Behavioral: Safe Sleep

Breastfeeding

EXPERIMENTAL

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

Behavioral: Breastfeeding

Safe Sleep and Breastfeeding

EXPERIMENTAL

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

Behavioral: Safe Sleep; Behavioral: Breastfeeding

Early Brain Development and Parent -Child Relationships

ACTIVE COMPARATOR

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.

Behavioral: Early Brain Development and Parent-Child Relationships

Interventions

Safe Sleep BEHAVIORAL

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.

Safe Sleep; Safe Sleep and Breastfeeding

Breastfeeding BEHAVIORAL

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.

Breastfeeding; Safe Sleep and Breastfeeding

Early Brain Development and Parent-Child Relationships BEHAVIORAL

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.

Early Brain Development and Parent -Child Relationships

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Medical Center: collaborator
• University of Kentucky: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• University of Virginia: lead
• Boston University: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Breast Feeding; Infant Death

Interventions

Lactation

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Postpartum Period

Study Officials

• Rachel Y Moon, MD

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Boguszewski, MA

CONTACT

434-243-9663; Keb5un@uvahealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)