Get Social Media and Risk-Reduction Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Virginia
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
A prenatal diagnosis expected to have impact on infant care practices not compatible with study goals, such as supine infant sleep positioning.
Trial design
Design model
Crossover
Treatments tested in this trial
TodaysBaby
BehavioralThe 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 .
Treatment groups
10,000 Participants
are divided into 3 treatment groupsGroup A: New low touch (LT) hospital implementation strategyExperimental treatment 1 intervention
Group B: Original high touch (HT) hospital implementation strategyActive comparator 1 intervention
Group C: Control- Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Penetration 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 birth2
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 birthSecondary outcomes
1
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 survey2
Acceptability
Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews)
Time frame
Within a year of participant enrollment3
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 periods4
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 birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Virginia
Lead sponsor
Washington University School of Medicine
Collaborator
Boston Medical Center
Collaborator
Boston University
Collaborator
University of Massachusetts, Worcester
Collaborator
Columbia University
Collaborator
University of Colorado, Denver
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov