RecruitingNot ApplicableNCT06618586

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Sponsor

University of Virginia

Enrollment

10,000 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study examines the implementation of the TodaysBaby™ mobile safe sleep intervention program in US hospitals. The main aims of this study are to examine: 1) differences in program penetration and the equity of penetration according to income and race/ethnicity; 2) differences in feasibility, acceptability, sustainability and fidelity top the intervention; and 3) the effectiveness of the intervention.


Eligibility

Sex: FEMALE

Inclusion Criteria5

  • Must speak English or Spanish
  • Must live in the United States
  • Must have given birth to a healthy, term infants (37 weeks or greater) and be discharged within 7 days of birth
  • Must plan to care for infant and live in the same household as infant after birth
  • Must enroll in the TodaysBaby program by the time their infant is 7 days of age

Exclusion Criteria1

  • A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.

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Interventions

BEHAVIORALTodaysBaby

The TodaysBaby intervention is comprised of: 1) Text message-delivered, short educational videos in the first 2 months after birth, with each video timed to match content addressing anticipated barriers and facilitators to adhering to guidelines (e.g. parental concerns that infant will choke while supine). Participants will also have access to a web portal where intervention videos will be maintained. 2) Text queries regarding safe sleep practices, which collect data on sleep practices in near real-time and provide reinforcement of adherence. Mothers will receive 1-2 text message questions weekly that assess sleep practices in near real-time .


Locations(1)

Boston University

Boston, Massachusetts, United States

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NCT06618586


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