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Purpose

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.

Conditions

  • Infant Death
  • Sudden Infant Death

Eligibility

Eligible Ages
All ages
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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 Criteria

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
This is a hybrid type 3 implementation-effectiveness cluster randomized trial at 20 US birth hospitals. In a crossover design separated by a 1-month washout period, we will test 2 strategies for recruitment of mothers into the 2-month-long TodaysBaby mobile safe sleep education program: 1) The original TodaysBaby implementation strategy (HT), in which hospital staff recruit mothers and view the first 2 videos with them; and 2) A new low-touch (LT) hospital implementation strategy, in which mothers are attracted to TodaysBaby through direct-to-consumer marketing and sign themselves up using a QR code.
Primary Purpose
Health Services Research
Masking
None (Open Label)
Masking Description
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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 .
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.
  • Behavioral: 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 .
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.

Recruiting Locations

Boston University
Boston, Massachusetts 02118
Contact:
Sarah Roth
617-734-6006
saroth@bu.edu

More Details

Status
Recruiting
Sponsor
University of Virginia

Study Contact

Sarah Roth, MPH
(617)206-6198
saroth@bu.edu