Social Media and Risk Reduction Teaching-Enhanced Reach (SMARTER)

February 5, 2024 updated by: Boston University

Improving Care Giver Adherence to Recommended Infant Care Practices

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fiona Rice, MPH
  • Phone Number: 617-206-6149
  • Email: fionar@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston University Medical Campus
        • Contact:
          • Fiona Rice, MPH
          • Phone Number: 617-206-6149
          • Email: fionar@bu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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: Postnatal Breastfeeding Mobile Health (mHealth) Messaging
Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
Behavioral: Prenatal Breastfeeding Mobile Health (mHealth) Messaging
Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usual 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 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
Time Frame: 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.
Between 2 and 6 months
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.
Between 2 and 6 months
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.
Between 2 and 6 months
Breast milk 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.
Between 2 and 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

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

Investigators

  • Principal Investigator: Michael J Corwin, MD, Boston University School of Public Health, Dept of Pediatrics, BUSM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-39495
  • R01HD072815-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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