Clinical trial NCT04387552: Social Media and Risk Reduction Teaching-Enhanced Reach
Official title: Improving Care Giver Adherence to Recommended Infant Care Practices
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breastfeeding
SUID
SIDS
Keywords: Breastfeeding (BF)
Sleep position
Safe Sleep (SS)
Mobile Messaging
Social Media
WIC
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: Washington University School of Medicine
name: Boston Medical Center
name: University of Kentucky
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-05-14
Enrollment: 2126
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Usual infant sleep position in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Usual infant sleep location in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Soft bedding use in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Pacifier use in the previous two weeks
timeFrame: Between 2 and 6 months
measure: Breast milk feeding in the previous two weeks
timeFrame: Between 2 and 6 months
Secondary outcomes:
measure: Age in weeks when Infant stopped supine sleep position
timeFrame: Weekly until the infant is 26 weeks of age.
measure: Age in weeks when infant stopped room sharing without bed sharing
timeFrame: Weekly until the infant is 26 weeks of age.
measure: Age in weeks when infant starts using soft bedding
timeFrame: Weekly until the infant is 26 weeks of age.
measure: Age in weeks when infant starts to use a pacifier
timeFrame: Weekly until the infant is 26 weeks of age.
measure: Age in weeks when infant breast milk feedings change
timeFrame: Weekly until the infant is 26 weeks of age.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University Medical Campus
state: Massachusetts
Study officials:
affiliation: Boston University School of Public Health, Dept of Pediatrics, BUSM
name: Michael J Corwin, MD
role: PRINCIPAL_INVESTIGATOR
References: