Clinical trial NCT05767658: Support Via Online Social Networks to Promote Safe Infant Care Practices
Official title: Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breastfeeding
Infant Death
Sudden Infant Death Syndrome Without Mention of Autopsy
Keywords: Safe Sleep
Breastfeeding
Social Media
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Boston University
name: Washington University School of Medicine
name: Boston Medical Center
name: University of Kentucky
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-03-14
Enrollment: 3000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Infant sleep position in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Infant sleep location in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Soft bedding use in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Pacifier use in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Breastmilk feeding in the previous two weeks
timeFrame: Between 2 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Campus
state: Massachusetts
Study officials:
affiliation: University of Virginia School of Medicine
name: Rachel Y Moon, MD
role: PRINCIPAL_INVESTIGATOR
References: