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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10,000
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 .
Boston University
Boston, Massachusetts, United States
RECRUITINGPenetration of sign up for TodaysBaby
Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies
Time frame: First week after birth
Equity of sign up for TodaysBaby
Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies
Time frame: First week after birth
Feasibility of implementation
Staff perception that the implementation strategies were successfully used or carried out (measured through semi-structured interviews; Rate of maternal report that signing up for TodaysBaby was simple and fast
Time frame: Within a year of participant enrollment (qualitative) and >60 day after birth survey
Acceptability
Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)
Time frame: Within a year of participant enrollment
Sustainability
Staff perception that the implementation strategies could continue to be delivered after the end of the study (measured through semi-structured interviews); monthly penetration rates
Time frame: Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods
Fidelity
Number of videos viewed by mother, divided by total videos among mothers enrolled in the different implementation strategies
Time frame: First 60 days after birth
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Effectiveness of TodaysBaby on safe sleep practices
We will measure 4 sleep practices in the past 2 weeks among mothers enrolled in the different implementation strategies: Sleep position: % reporting supine position only Sleep location: % reporting roomsharing not bedsharing only Soft bedding: % reporting no soft bedding in sleep space Pacifier: % reporting usual pacifier use when infant sleeping
Time frame: 60-180 days (average 80 days) after birth survey
Program cost of TodaysBaby
Differences in rate of sign up for TodaysBaby by maternal insurance status and race/ethnicity among mothers that sign up during different implementation strategies
Time frame: 60-180 days during the program sign up periods.