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ACTIVE NOT RECRUITING
NCT06087133
NA

Prenatal Starting Early Program mHealth

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

Official title: Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy

Key Details

Gender

FEMALE

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

276

Start Date

2023-12-08

Completion Date

2026-04-14

Last Updated

2025-07-11

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

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.

OTHER

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).

Locations (1)

NYC Health + Hospitals/Bellevue

New York, New York, United States