Evaluating lifestyle counseling strategies for pregnant women
Bridging Maternal Lifestyle Education, and Counseling With Community Health Workers and Health Equity - Phase II
This study is testing two different ways to provide lifestyle advice to pregnant women—one using text messages and videos, and the other with help from community health workers—to see which works better for their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Female |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06349070 on ClinicalTrials.gov |
What this trial studies
This study evaluates two different strategies for delivering lifestyle counseling to pregnant women: a low-touch approach using text messaging and online videos, and a high-touch approach led by Community Health Workers. The study will involve interviews and focus groups with clinic providers and staff before implementation, and a subsample of participants will complete surveys during and after pregnancy. The primary goals are to compare the adoption rates of each strategy, assess implementation fidelity, and evaluate their impacts on maternal health.
Who should consider this trial
Good fit: Ideal candidates are pregnant women under 20 weeks gestational age, aged 18 or older, who can communicate in English or Spanish and have access to a smartphone with internet.
Not a fit: Patients with significant psychiatric or developmental disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve maternal health outcomes by identifying effective counseling delivery methods for pregnant women.
How similar studies have performed: Other studies have shown success with community-based participatory approaches in maternal health, suggesting potential for positive outcomes in this study.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York and 1 other locations
- NYC Health + Hospitals/Bellevue — New York, New York, United States (Recruiting)
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Natasha Williams, EdD — NYU Langone Health
- Study coordinator: Natasha Williams, EdD
- Email: Natasha.williams2@nyulangone.org
- Phone: 646-501-3433
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.