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Part of paid clinical trials in Boston, Massachusetts.

Sponsor
University of Virginia
Study ID
NCT06618586
Status
Recruiting
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Conditions

  • Infant Death
  • Sudden Infant Death

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • TodaysBaby — BEHAVIORAL
    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 .

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
10,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: New low touch (LT) hospital implementation strategy
    This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm mothers will be attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code. These mothers will also receive standard postpartum care.
  • Active Comparator: Original high touch (HT) hospital implementation strategy
    This will occur during either the first or second 6-month intervention time period (order randomly assigned). For the period of time hospitals are randomized into this arm hospital staff will help mothers sign up and view the first 2 TodaysBaby in a one-on-one conversation format. These mothers will also receive standard postpartum care.
  • No Intervention: Control- Standard of Care
    During the 3 months immediately prior to the first intervention time period, hospitals will recruit approximately 100 mothers to complete surveys regarding infant care practices. These mothers will also receive postpartum standard of care.

Primary Outcome Measure

Penetration of sign up for TodaysBaby [ Time Frame: First week after birth ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston UniversityBostonMassachusetts02118
Sarah Roth
[email protected]
617-734-6006

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By research site
Boston University· Boston, MA

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