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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD110568-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Boston Medical Center | OTHER |
| Boston University | OTHER |
| University of Massachusetts, Worcester |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New low touch (LT) hospital implementation strategy | Experimental | 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. |
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| Original high touch (HT) hospital implementation strategy | Active Comparator | 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. |
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| Control- Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 . |
| Measure | Description | Time Frame |
|---|---|---|
| Penetration of sign up for TodaysBaby | Rate of sign up for TodaysBaby among mothers that sign up during the different implementation strategies | 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 | First week after birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within a year of participant enrollment (qualitative) and >60 day after birth survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Roth, MPH | Contact | (617)206-6198 | saroth@bu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rachel Y Moon, MD | University of Virginia School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston University | Recruiting | Boston | Massachusetts | 02118 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41814244 | Derived | Moon RY, Hwang SS, Hauck FR, Kellams AL, Shafer PR, Colvin BN, Karpman H, Carlin RF, Corwin MJ, Colson E, Parker MG. Get Social Media and Risk-Reduction Training (GET SMART) to improve infant safe sleep practices through a mobile text message-delivered video safe sleep intervention for new parents: study protocol for a type 3 hybrid implementation-effectiveness cluster randomized trial in 20 US birth hospitals. BMC Pediatr. 2026 Mar 11;26(1):346. doi: 10.1186/s12887-026-06715-8. |
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| ID | Term |
|---|---|
| D066088 | Infant Death |
| D013398 | Sudden Infant Death |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003645 | Death, Sudden |
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| OTHER |
| Columbia University | OTHER |
| University of Colorado, Denver | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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.
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None (Open Label)
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| Acceptability |
Staff perception that the delivery of the implementation strategies was satisfactory (measured through semi-structured interviews) |
| 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 | 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 | First 60 days after birth |
| 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 | 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 | 60-180 days during the program sign up periods. |