Social Media and Risk Reduction Teaching-Enhanced Reach

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) through direct education of mothers using Mobile Health (mHealth) technologies (ex. text messaging).

Detailed Description
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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.

Official Title
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Improving Care Giver Adherence to Recommended Infant Care Practices

Conditions
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Breastfeeding, SUID, SIDS

Intervention / Treatment
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* Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging
* Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging
* Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging
* Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prenatal SS/Postnatal BF<br>Prenatal Safe Sleep/Postnatal Breastfeeding Mobile Health Messages | Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging<br>* Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.<br>Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging<br>* Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.<br>|
| Experimental: Prenatal BF/Postnatal SS<br>Prenatal Breastfeeding/Postnatal Safe Sleep Mobile Health Messages | Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging<br>* Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.<br>Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging<br>* Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.<br>|
| Experimental: Prenatal SS/Postnatal SS<br>Prenatal Safe Sleep/Postnatal Safe Sleep Mobile Health Messages | Behavioral: Prenatal Safe Sleep Mobile Health (mHealth) Messaging<br>* Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.<br>Behavioral: Postnatal Safe Sleep Mobile Health (mHealth) Messaging<br>* Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.<br>|
| Experimental: Prenatal BF/Postnatal BF<br>Prenatal Breastfeeding/Postnatal Breastfeeding Mobile Health Messages | Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging<br>* Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.<br>Behavioral: Postnatal Breastfeeding Mobile Health (mHealth) Messaging<br>* Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usual 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 | 
| Usual 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 | 
| Breast milk 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age in weeks when Infant stopped supine sleep position | The infant's age in weeks when supine sleep position is stopped will be assessed by maternal response to weekly text messages about sleep position during the past week. | Weekly until the infant is 26 weeks of age. | 
| Age in weeks when infant stopped room sharing without bed sharing | The infant's age in weeks when sleep location of room sharing without bed sharing stopped will be assessed by maternal response to weekly text messages about sleep location during the past week. | Weekly until the infant is 26 weeks of age. | 
| Age in weeks when infant starts using soft bedding | The infant's age in weeks when soft bedding use starts will be assessed by maternal response to weekly text messages about type of bedding during the past week. | Weekly until the infant is 26 weeks of age. | 
| Age in weeks when infant starts to use a pacifier | The infant's age in weeks when pacifier use started will be assessed by maternal response to weekly text messages about pacifier use during the past week. | Weekly until the infant is 26 weeks of age. | 
| Age in weeks when infant breast milk feedings change | The infant's age in weeks when breast feeding changed will be assessed by maternal response to weekly text messages about type of breast feeding categorized as either exclusive, partial or no breast milk during the past week. | Weekly until the infant is 26 weeks of age. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WIC, Breastfeeding (BF), Sleep position, Safe Sleep (SS), Mobile Messaging, Social Media