Community-wide prevention program for maternal and infant health
Evaluation of the Navigation Prevention Program: Durham
NA · Duke University · NCT04438031
This study is testing a new community program called 'Navigation' to see if it can help improve the health of mothers and their babies by connecting them with the right healthcare resources.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 0 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04438031 on ClinicalTrials.gov |
What this trial studies
This study evaluates the implementation and impact of a new community-wide prevention program called 'Navigation' aimed at improving maternal and infant health. The program recruits mothers during their OB/GYN or pediatrician visits and provides multiple follow-up visits to assess family needs and connect them with healthcare providers. The study aims to enroll 800 families, focusing on their health and well-being over a period of 36 months. Data from a previous version of the program will not be included in the analysis due to design changes.
Who should consider this trial
Good fit: Ideal candidates for this study are families attending specific OB/GYN offices for their first prenatal visit or those visiting a pediatric care practice for their child's well visits.
Not a fit: Families residing outside of Durham County or those planning to move shortly will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance maternal and infant health outcomes by providing tailored support and resources.
How similar studies have performed: While similar community-based health interventions have shown promise, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Families will be eligible for the study if they go to the certain OB/GYN offices (to be updated later) for their first prenatal visit * Families will be eligible for the study if they go to the Roxboro Road Pediatric Care Practice for their child's 12-, 24-, or 36-month well visit * Primary language is English or Spanish Exclusion Criteria: * Families residing outside of Durham County * Families that are planning to move out of either county within the next 2 months at the time of recruitment * Families will also be ineligible if the parent has a cognitive impairment that impairs their ability to consent/participate.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Kenneth Dodge, PhD — Duke University
- Study coordinator: W. Benjamin Goodman, PhD
- Email: ben.goodman@duke.edu
- Phone: 919-668-4126
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.
Conditions: Prenatal, Postnatal