Prenatal Starting Early Program mHealth

NYU Langone Health

Status: Active, not recruiting

Conditions: Pregnancy

Treatments: Other: Routine Care; Behavioral: StEP:Prenatal

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06087133

23-00902

Details and patient eligibility

About

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 prenatal and pediatric care at Bellevue Hospital. The primary aims are to determine the efficacy of the remotely delivered StEP:Prenatal intervention on diet, lifestyle behaviors, social determinants of health (SDoH), and pregnancy outcomes.

Enrollment: 276 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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276 participants in 2 patient groups

Routine Care + StEP:Prenatal

Experimental group

Description:

Participants will receive routine care and up to 8 StEP:Prenatal sessions. Routine care will follow through the post-partum period.

Treatment:

Behavioral: StEP:Prenatal

Other: Routine Care

Routine Care

Active Comparator group

Description:

Participants will receive routine care during pregnancy and the post-partum period.

Treatment:

Other: Routine Care