Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10000 participants
INTERVENTIONAL
2025-05-01
2028-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
TodaysBaby
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 .
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.
TodaysBaby
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 .
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.
No interventions assigned to this group
Interventions
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TodaysBaby
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 .
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
FEMALE
Yes
Sponsors
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Washington University School of Medicine
OTHER
Boston Medical Center
OTHER
Boston University
OTHER
University of Massachusetts, Worcester
OTHER
Columbia University
OTHER
University of Colorado, Denver
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Virginia
OTHER
Responsible Party
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Rachel Moon, MD
Professor, Department of Pediatrics
Principal Investigators
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Rachel Y Moon, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia School of Medicine
Locations
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Boston University
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202401227
Identifier Type: -
Identifier Source: org_study_id
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