SMARTER: Social Media and Risk Reduction Teaching-Enhanced Reach

Sponsor

Boston University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04387552

Collaborator

University of Virginia (Other), Washington University School of Medicine (Other), Boston Medical Center (Other), University of Kentucky (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

2,500

Enrollment

Location

Arms

27.3

Anticipated Duration (Months)

91.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding SUID SIDS	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	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2500 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Improving Care Giver Adherence to Recommended Infant Care Practices

Actual Study Start Date :

Jan 20, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Usual infant sleep position in the previous two weeks [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.
Usual infant sleep location in the previous two weeks [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.
Soft bedding use in the previous two weeks [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.
Pacifier use in the previous two weeks [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.
Breast milk feeding in the previous two weeks [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.

Secondary Outcome Measures

Age in weeks when Infant stopped supine sleep position [Weekly until the infant is 26 weeks of age.]
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.
Age in weeks when infant stopped room sharing without bed sharing [Weekly until the infant is 26 weeks of age.]
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.
Age in weeks when infant starts using soft bedding [Weekly until the infant is 26 weeks of age.]
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.
Age in weeks when infant starts to use a pacifier [Weekly until the infant is 26 weeks of age.]
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.
Age in weeks when infant breast milk feedings change [Weekly until the infant is 26 weeks of age.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston University Medical Campus	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

Boston University
University of Virginia
Washington University School of Medicine
Boston Medical Center
University of Kentucky
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)