Nurse Family Partnership for Women With Previous Live Births
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Terminated
- People taking part
- 23 people enrolled
- Started
- 29 Apr 2024
- Ended
- 31 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Nurse Family Partnership
- Record updated
- 4 September 2025
- Why it stopped
- Recruitment milestones not met; funding withdrawn
Who can take part
- Age
- 16 years to 46 years
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
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Who can take part
- pregnant at 32 weeks EGA or less
- history of previous live birth
- covered by Medicaid or Medicaid-eligible
- at least one of the following risks or adversities -age 19 or younger, no high school degree or equivalent, homeless (using a standardized definition), previous birth with low birth weight or prematurity, previous pregnancy with severe morbidity based on Centers for Disease Control definition, current pregnancy within 18 months of previous pregnancy, currently using tobacco or marijuana, history of substance use disorder, and self-identification as Black/African American (as a marker of facing the adversity of structural racism)
Who cannot take part
- have previously been enrolled in NFP
- under the age of 16 years. Note that we propose to exclude those who don't speak English or Spanish from our study because the community served by the two NFP delivery sites participating in our study is mostly English-speaking with some Spanish-speaking. However, those who don't speak English or Spanish are not excluded from participation in NFP, and NFP routinely provides services to all eligible families regardless of language spoken using bilingual/multilingual nurses when available or using interpretation services. NFP materials for nurses to use with families, known as 'facilitators', are available in several languages. In the rare circumstance that a pregnant woman is excluded from participating in our study based on language, they will not be excluded from receiving NFP
- unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
- are already enrolled in a home-visiting intervention with this pregnancy
Where in United States
- Nationwide Children's HospitalColumbus, United States
About the trial
What the trial wants to find out
The goal of this clinical trial is to test the Nurse Family Partnership (NFP) in mothers with previous live births (multiparous or multip individuals). The main aims are:
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Specific Aim 1-Determine the effectiveness of NFP among multiparous women for reducing maternal morbidity and improving pregnancy outcomes.
Specific Aim 2-Determine the effectiveness of NFP among index children (child from pregnancy when mother was enrolled) of multiparous women for improving child outcomes.
Specific Aim 3 (Exploratory)-In preparation for a future study of the effects of preventive home-visiting programs on mother-index child-sibling triads, describe siblings (characteristics, role, influence) in the context of nurse home-visiting and evaluate the effectiveness of NFP on outcomes for prior-born siblings younger than 6 years old living in the home, including cognitive development, socioemotional development, and identification and referral to needed services.
A supplemental study to this study, led by investigators at Yale and Columbia, includes the following Aims:
Aim 1: Test whether the NFP causes variation in DNAm at Glucocorticoid-sensitive sites in infants over the first year of life.
Aim 2: Determine whether NFP causes differences in epigenetic age in infants over the first year of life.
Aim 3: Evaluate DNAm signatures as predictors of infant development at 12 months of age.
The 2 groups in the trial
- Intervention (NFP)Existing treatment, for comparison
In the standard NFP intervention, low-income pregnant women are recruited to voluntarily join the program through their 28th week of pregnancy. Enrolled women receive home visits from a nurse. The visits can occur in-person or via telehealth. In-person visits can occur in the client's home or in another community location agreed upon by the client and the nurse (such as a library or coffee shop). The typical schedule for visits is weekly during the first month after enrollment, every two weeks until the birth of the infant, weekly during the post-partum period, then every two to four weeks until child age two.
Treatment: Nurse Family Partnership
- ControlNo study treatment, for comparison
The control group will receive usual care for pregnant people, which may include home visiting services from another source other than NFP. Participants who are randomly selected to receive other services will be given information about other services for which they may qualify and information about how to access those services.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Trial of Nurse Family Partnership for Women With Previous Live Births
- Record updated
- 4 September 2025