Status:

ACTIVE_NOT_RECRUITING

Prenatal Starting Early Program mHealth

Lead Sponsor:

NYU Langone Health

Collaborating Sponsors:

United States Department of Agriculture (USDA)

Conditions:

Pregnancy

Eligibility:

FEMALE

18-99 years

Phase:

NA

Brief Summary

The purpose of this interventional trial is to test the efficacy of the remote delivery of the StEP:Prenatal intervention compared to standard prenatal care in pregnant individuals planning to receive...

Eligibility Criteria

Inclusion

  • Currently pregnant in the first trimester (up to 13 weeks, 6 days)
  • Speak English or Spanish fluently
  • Intent to receive prenatal and pediatric care at Bellevue
  • ≥18 years
  • Have a smart phone or device with internet access
  • Willing and able to provide consent

Exclusion

  • Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).
  • Note: Diabetes, hypertension, depression are not excluded.
  • Living in a shelter
  • Receiving treatment for drug or alcohol use

Key Trial Info

Start Date :

December 8 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 14 2026

Estimated Enrollment :

276 Patients enrolled

Trial Details

Trial ID

NCT06087133

Start Date

December 8 2023

End Date

April 14 2026

Last Update

July 11 2025

Active Locations (1)

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NYC Health + Hospitals/Bellevue

New York, New York, United States, 10016