Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The RESTORE trial is a research study aimed at improving maternal health by testing two different ways to provide lifestyle counseling to pregnant women. The study will compare a technology-supported approach, where participants receive text messages and can watch videos online, to a more hands-on method led by Community Health Workers who will guide both group and individual sessions. The goal is to see which method works better for helping pregnant women adopt healthy habits and how well these strategies are implemented in real-life settings.
To participate in the trial, women must be confirmed pregnant for less than 20 weeks and be receiving care at one of the 10 participating clinics. They should be at least 18 years old, able to read and speak English or Spanish, and have a smartphone or mobile device with internet access. Participants will be asked to complete surveys during their pregnancy and after giving birth, providing valuable feedback on their experiences. This study is currently recruiting participants, and it will also assess how well the strategies continue to be used after the initial support period and evaluate the costs associated with each method.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria (Implementation Group (Low Touch and High Touch)):
- • Confirmed pregnant and \<20 weeks 0 days gestational age
- • receiving care at one of the 10 clinics
- • ≥18 years old
- • able to speak and read English or Spanish
- • Has a smartphone or mobile device with a data plan to accept text messages and internet connection to watch videos
- Inclusion Criteria (Follow-up Group):
- • Enrolled as a subject in the Implementation Group (Low Touch or High Touch) within the first trimester (before the end of the 13th week (13w6d))
- • willing and able to provide consent for baseline and follow up surveys
- Exclusion Criteria:
- • Significant psychiatric or developmental disability as noted in the medical record.
About Nyu Langone Health
NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
New York, New York, United States
Patients applied
Trial Officials
Natasha Williams, EdD
Principal Investigator
NYU Langone Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported