Support Via Online Social Networks to Promote Safe Infant Care Practices Toward Reducing Racial Disparities in Infant Mortality
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Exclusive infant supine sleep position in the previous two weeks
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Safe Sleep (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
干预措施: Breastfeeding (Behavioral)
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
干预措施: Safe Sleep (Behavioral)
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
干预措施: Breastfeeding (Behavioral)
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.
干预措施: Early Brain Development and Parent-Child Relationships (Behavioral)
结局指标
主要结局
Exclusive infant supine sleep position in the previous two weeks
时间窗: Between 2 and 6 months
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.
Infant sleep location (exclusive room sharing without bed sharing) in the previous two weeks
时间窗: Between 2 and 6 months
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.
Soft bedding use in the previous two weeks
时间窗: Between 2 and 6 months
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.
Breastmilk feeding in the previous two weeks
时间窗: Between 2 and 6 months
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.
次要结局
- 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)
研究者
Rachel Moon, MD
Professor, Department of Pediatrics
University of Virginia