ACTIVE_NOT_RECRUITING

Prenatal Starting Early Program mHealth

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-12-08
Study Completion:2026-04-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06087133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently pregnant in the first trimester (up to 13 weeks, 6 days)
  2. * Speak English or Spanish fluently
  3. * Intent to receive prenatal and pediatric care at Bellevue
  4. * ≥18 years
  5. * Have a smart phone or device with internet access
  6. * Willing and able to provide consent
  1. * Severe illness (severe medical or mental health condition e.g. cancer, epilepsy neuromuscular disease, psychosis or bipolar disorder).
  2. * Living in a shelter
  3. * Receiving treatment for drug or alcohol use

Contacts and Locations

Principal Investigator

Mary Messito, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYC Health + Hospitals/Bellevue
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Mary Messito, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-08
Study Completion Date2026-04-14

Study Record Updates

Study Start Date2023-12-08
Study Completion Date2026-04-14

Terms related to this study

Keywords Provided by Researchers

  • Prenatal care

Additional Relevant MeSH Terms

  • Pregnancy