Improving Care Giver Adherence to Recommended Infant Care Practices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,093
- 试验地点
- 1
- 主要终点
- Number of Infants Usually Sleeping Supine 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) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).
详细描述
The goal of this study is to assess the effectiveness of mHealth prenatal and postnatal interventions aimed at promoting safe sleep (SS) practices and breastfeeding (BF) within a population of pregnant Supplemental Nutrition Program for Women, Infants, and Children (WIC) clients.
The study will randomize 2,000 pregnant women, when they reach 34 weeks gestation, to one of four mHealth prenatal/postnatal messaging combinations of safe sleep and breastfeeding practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Must be client at a WIC center participating in study.
- •Must be pregnant and less than 34 weeks gestation
- •Must speak English or Spanish
- •Must live in the United States
- •Must have texting capabilities via mobile phone
- •Must plan to live in same household as infant after birth.
排除标准
- •A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, including contraindications to breastfeeding or supine infant sleep positioning.
- •Meets the definition of a minor according to applicable state law.
研究组 & 干预措施
Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
干预措施: Prenatal Safe Sleep Mobile Health (mHealth) Messaging (Behavioral)
Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
干预措施: Postnatal Safe Sleep Mobile Health (mHealth) Messaging (Behavioral)
Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
干预措施: Prenatal Breastfeeding Mobile Health (mHealth) Messaging (Behavioral)
Prenatal SS/Postnatal BF
Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages
干预措施: Postnatal Breastfeeding Mobile Health (mHealth) Messaging (Behavioral)
Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
干预措施: Prenatal Breastfeeding Mobile Health (mHealth) Messaging (Behavioral)
Prenatal BF/Postnatal SS
Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages
干预措施: Postnatal Safe Sleep Mobile Health (mHealth) Messaging (Behavioral)
Prenatal SS/Postnatal SS
Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages
干预措施: Prenatal Safe Sleep Mobile Health (mHealth) Messaging (Behavioral)
Prenatal BF/Postnatal BF
Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages
干预措施: Postnatal Breastfeeding Mobile Health (mHealth) Messaging (Behavioral)
结局指标
主要结局
Number of Infants Usually Sleeping Supine in the Previous Two Weeks
时间窗: Between 2 and 6 months following postnatal randomization, on average 67.7 days
An investigator-developed maternal survey will be used to assess infant's sleep position during the previous two weeks with categorical responses of supine (back), prone (stomach), side, and other.
Number of Infants Usually Room Sharing Without Bedsharing in the Previous Two Weeks
时间窗: Between 2 and 6 months following postnatal randomization, on average 67.7 days
An investigator-developed maternal survey will be used to assess the infant's 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.
Number of Infants With no Soft Bedding Use in the Previous Two Weeks
时间窗: Between 2 and 6 months following postnatal randomization, on average 67.7 days
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.
Number of Infants With Pacifier Use in the Previous Two Weeks
时间窗: Between 2 and 6 months following postnatal randomization, on average 67.7 days
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.
Number of Infants With Any Breastmilk Feeding in the Previous Two Weeks
时间窗: Between 2 and 6 months following postnatal randomization, on average 67.7 days
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.
Infant 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 sleep position during the previous two weeks with categorical responses of back, stomach, side, and other. We will examine: A) Usual position; B) Exclusive use of supine position
Infant sleep location 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 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. We will examine: A) Usual location; B) Exclusive location of room sharing without bedsharing
Any 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.
Any Pacifier use 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 pacifier use during the previous two weeks with categorical responses of Yes or No.
Infant 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. We will examine: A) Any breast milk feeding; B) Exclusive breast milk feeding
次要结局
- Number of Infants Exclusively Sleeping Supine in the Previous Two Weeks(Between 2 and 6 months following postnatal randomization, on average 67.7 days)
- Number of Infants Exclusively Room Sharing Without Bedsharing in the Previous Two Weeks(Between 2 and 6 months following postnatal randomization, on average 67.7 days)
- Number of Infants With Exclusive Breastmilk Feeding in the Previous Two Weeks(Between 2 and 6 months following postnatal randomization, on average 67.7 days)
- Any Initiation of breast milk feeding(Between 36 weeks gestational age and birth)
- Planned infant sleep position after birth of baby(Between 36 weeks gestational age and birth.)
- Planned infant sleep location after birth of baby(Between 36 weeks gestational age and birth.)
- Planned breast milk feeding after birth of baby(Between 36 weeks gestational age and birth.)
- Planned duration of breast milk feeding after birth of baby(Between 36 weeks gestational age and birth)
- Days from postnatal randomization to first report of not exclusively in the supine sleep position(Weekly until the infant is 26 weeks of age.)
- Days from postnatal randomization to first report of not exclusively room sharing without bed sharing(Weekly until the infant is 26 weeks of age.)
- Days from postnatal randomization to first report of using any soft bedding(Weekly until the infant is 26 weeks of age.)
- Days from postnatal randomization to first report of not receiving exclusively Breast Milk feedings(Weekly until the infant is 26 weeks of age.)
- Days from postnatal randomization to first report of not receiving any Breast Milk feedings(Weekly until the infant is 26 weeks of age.)