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Completed

NCT Number: NCT04387552

Social Media and Risk Reduction Teaching-Enhanced Reach

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).

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Death Death, Sudden Feeding Behavior Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms SIDS SUID Sudden Infant Death

Age range

14 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prenatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral

Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.

Prenatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral

Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.

Postnatal Safe Sleep Mobile Health (mHealth) Messaging

Behavioral

Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.

Postnatal Breastfeeding Mobile Health (mHealth) Messaging

Behavioral

Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.

Primary outcomes

  1. Infant sleep position in the previous two weeks

    Time frame: 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

  2. Infant sleep location in the previous two weeks

    Time frame: 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

  3. Any Soft bedding use in the previous two weeks

    Time frame: 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.

  4. Any Pacifier use in the previous two weeks

    Time frame: 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.

  5. Infant feeding in the previous two weeks

    Time frame: 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

Secondary outcomes

  1. Any Initiation of breast milk feeding

    Time frame: Between 36 weeks gestational age and birth

    The impact of the only the prenatal intervention on initiation of breast milk feeding obtained through maternal survey responses on the prenatal survey

  2. Planned infant sleep position after birth of baby

    Time frame: Between 36 weeks gestational age and birth.

    The impact of the only the prenatal intervention on planned infant sleep position after birth of baby obtained through maternal survey responses on the prenatal survey

  3. Planned infant sleep location after birth of baby

    Time frame: Between 36 weeks gestational age and birth.

    The impact of the only the prenatal intervention on planned infant sleep location after birth of baby obtained through maternal survey responses on the prenatal survey

  4. Planned breast milk feeding after birth of baby

    Time frame: Between 36 weeks gestational age and birth.

    The impact of the only the prenatal intervention on planned breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey

  5. Planned duration of breast milk feeding after birth of baby

    Time frame: Between 36 weeks gestational age and birth

    An investigator-developed maternal prenatal survey will be used to assess planned duration of breast milk feeding after birth of baby obtained through maternal survey responses on the prenatal survey

  6. Days from postnatal randomization to first report of not exclusively in the supine sleep position

    Time frame: Weekly until the infant is 26 weeks of age.

    The number of days after postnatal randomization when supine sleep position is stopped will be assessed by maternal response to weekly text messages about sleep position during the past week.

  7. Days from postnatal randomization to first report of not exclusively room sharing without bed sharing

    Time frame: Weekly until the infant is 26 weeks of age.

    The number of days after postnatal randomization 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.

  8. Days from postnatal randomization to first report of using any soft bedding

    Time frame: Weekly until the infant is 26 weeks of age.

    The number of days after postnatal randomization when soft bedding use starts will be assessed by maternal response to weekly text messages about type of bedding during the past week.

  9. Days from postnatal randomization to first report of not receiving exclusively Breast Milk feedings

    Time frame: Weekly until the infant is 26 weeks of age.

    The days from postnatal randomization 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.

  10. Days from postnatal randomization to first report of not receiving any Breast Milk feedings

    Time frame: Weekly until the infant is 26 weeks of age.

    The number of days after postnatal randomization to first report of not receiving any Breast Milk feedings will be assessed by maternal response to weekly text messages about type of breast feeding categorized as or no breast milk during the past week.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

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

Registry information

Official study title

Improving Care Giver Adherence to Recommended Infant Care Practices

Acronym: SMARTER

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 14, 2020
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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