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NCT06618586 | Recruiting DMC

• 2 other identifiers: 202401227R01HD110568-01A1
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Safe Sleep; Mobile Messaging

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• Feasibility of implementation

  Within a year of participant enrollment (qualitative) and >60 day after birth survey

• Acceptability

  Within a year of participant enrollment

• Sustainability

  Within a year of participant enrollment (qualitative) and during the 6-month study implementation periods

• Fidelity

  First 60 days after birth

• Effectiveness of TodaysBaby on safe sleep practices

  60-180 days (average 80 days) after birth survey

Study Arms (3)

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.

Behavioral: TodaysBaby

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.

Behavioral: TodaysBaby

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.

Interventions

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 .

New low touch (LT) hospital implementation strategy; Original high touch (HT) hospital implementation strategy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• 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

Study Sites (1)

Boston University

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Infant Death; Sudden Infant Death

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death, Sudden

Study Officials

• Rachel Y Moon, MD

  University of Virginia School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Roth, MPH

CONTACT

(617)206-6198; saroth@bu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: October 1, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)