Remote prenatal care program for pregnant individuals
Prenatal Starting Early Program: Randomized Controlled Trial of an mHealth Intervention in Prenatal Care and Wic to Improve Nutrition and Physical Activity During Pregnancy
This study tests a new remote prenatal care program using smartphones to see if it helps pregnant individuals improve their health and pregnancy outcomes better than regular in-person care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06087133 on ClinicalTrials.gov |
What this trial studies
This interventional trial evaluates the effectiveness of the StEP:Prenatal program, which delivers prenatal care remotely, compared to standard prenatal care. The study focuses on improving diet, lifestyle behaviors, and social determinants of health among pregnant individuals. Participants will be monitored for pregnancy outcomes while receiving care through their smartphones. The trial aims to enhance prenatal care accessibility and effectiveness for those planning to receive care at Bellevue Hospital.
Who should consider this trial
Good fit: Ideal candidates are pregnant individuals in their first trimester who are fluent in English or Spanish and have access to a smartphone with internet.
Not a fit: Patients with severe medical or mental health conditions, those living in shelters, or receiving treatment for substance use may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could improve pregnancy outcomes and overall health for pregnant individuals through enhanced access to prenatal care.
How similar studies have performed: Other studies have shown success with remote prenatal care interventions, indicating potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- NYC Health + Hospitals/Bellevue — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mary Messito, MD — NYU Langone Health
- Study coordinator: Mary Messito, MD
- Email: Mary.Messito@nyulangone.org
- Phone: 212-263-6424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.