Prenatal Starting Early Program mHealth

NCT ID: NCT06087133

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2026-04-14

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 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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Routine Care + StEP:Prenatal

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

Group Type: EXPERIMENTAL

StEP:Prenatal

Intervention Type: BEHAVIORAL

StEP is a health care-based intervention based on elements of Social Cognitive Theory, in which registered dietitians with additional certified lactation counselor training (RD/CLC) provide individual and group-based support for healthy diet, physical activity, other lifestyle behaviors, stress reduction, and healthy gestational weight gain. StEP:Prenatal will be delivered remotely. There are up to 8 sessions scheduled around the routine prenatal care visits and designed to be offered from the first trimester of pregnancy through delivery.

Routine Care

Intervention Type: OTHER

Routine care includes routine prenatal and post-partum primary care visits, on-site WIC services and referrals for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional nutrition visits).

Routine Care

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

Group Type: ACTIVE_COMPARATOR

Routine Care

Intervention Type: OTHER

Routine care includes routine prenatal and post-partum primary care visits, on-site WIC services and referrals for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional nutrition visits).

Interventions

StEP:Prenatal

StEP is a health care-based intervention based on elements of Social Cognitive Theory, in which registered dietitians with additional certified lactation counselor training (RD/CLC) provide individual and group-based support for healthy diet, physical activity, other lifestyle behaviors, stress reduction, and healthy gestational weight gain. StEP:Prenatal will be delivered remotely. There are up to 8 sessions scheduled around the routine prenatal care visits and designed to be offered from the first trimester of pregnancy through delivery.

Intervention Type: BEHAVIORAL

Routine Care

Routine care includes routine prenatal and post-partum primary care visits, on-site WIC services and referrals for additional services as needed (e.g., women with poor weight gain, obesity, or diabetes may be offered additional nutrition visits).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Agriculture (USDA)

FED

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Messito, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYC Health + Hospitals/Bellevue

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

23-00902

Identifier Type: -

Identifier Source: org_study_id