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RecruitingNCT06618586

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Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
10,000 (estimated)
Sponsor
University of Virginia · Academic / Other
Sex
Female
Age
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALTodaysBabyThe 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 .

Timeline

Start date
2025-05-01
Primary completion
2027-06-01
Completion
2028-06-01
First posted
2024-10-01
Last updated
2025-06-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06618586. Inclusion in this directory is not an endorsement.