Support Via Online Social Networks to Promote Safe Infant Care Practices

NCT ID: NCT05767658

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-07-01

Brief Summary

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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

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Conditions

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Breastfeeding Infant Death Sudden Infant Death Syndrome Without Mention of Autopsy

Keywords

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Safe Sleep Breastfeeding Social Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Safe Sleep

Intervention Type 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.

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

Group Type EXPERIMENTAL

Breastfeeding

Intervention Type 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.

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

Group Type EXPERIMENTAL

Safe Sleep

Intervention Type 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.

Breastfeeding

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Early Brain Development and Parent-Child Relationships

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Boston University

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role collaborator

University of Kentucky

OTHER

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Rachel Moon, MD

Professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Y Moon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia School of Medicine

Locations

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Boston University Medical Campus

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine Boguszewski, MA

Role: CONTACT

Phone: 434-243-9663

Email: [email protected]

Facility Contacts

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Katherine Boguszewski, MA

Role: primary

Other Identifiers

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5R01MD007702-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-43455

Identifier Type: -

Identifier Source: org_study_id