Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality

Study Overview
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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.

Official Title
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Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality

Conditions
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Breastfeeding, Sudden Infant Death Syndrome (SIDS), Sudden Unexplained Infant Death (SUID)

Intervention / Treatment
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* Behavioral: Safe Sleep
* Behavioral: Breastfeeding
* Behavioral: Safe Sleep and Breastfeeding
* Behavioral: Early Brain Development and Parent-Child Relationships


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be enrolled (or in process of enrolling) at a participating WIC center Must be English speaking Must be pregnant and less than 30 weeks gestation Must live in the United States Must have daily 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 breastfeeding 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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Safe Sleep<br> | Behavioral: Safe Sleep<br>* 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.<br>|
| Experimental: Breastfeeding<br> | Behavioral: Breastfeeding<br>* 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.<br>|
| Experimental: Safe Sleep and Breastfeeding<br> | Behavioral: Safe Sleep and Breastfeeding<br>* 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 (combined intervention) b) an online community and social network of other pregnant WIC clients and new parents.<br>|
| Active Comparator: Early Brain Development and Parent -Child Relationships<br> | Behavioral: Early Brain Development and Parent-Child Relationships<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant 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. | Between 2 and 6 months | 
| Infant sleep location 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. | 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 | 
| Pacifier use in the previous two weeks | An investigator-developed maternal survey will be used to assess the infant's pacifier use 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safe Sleep, Breastfeeding, Social Media, Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)