Nurse Family Partnership for Women With Previous Live Births

Trial of Nurse Family Partnership for Women With Previous Live Births

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:

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy, High Risk; Post Partum Depression; Child Development
• Intervention / Treatment: Behavioral: Nurse Family Partnership

Detailed Description

The proposed study will be conducted in partnership with two or more NFP sites in Columbus and Dayton, Ohio. Investigators will work with pregnancy resource referral centers to identify a process that fits into each site's flow for identifying and recruiting eligible multiparous pregnant women at 32 weeks EGA (estimated gestational age) or less to participate in the study. The study will recruit 500 women to participate. Half will be receiving NFP and half will be receiving any other community services available outside of NFP. Researchers will compare the intervention group with the control group to test the effects described in the Aims above (as outlined in the following hypotheses).

Hypothesis 1-Compared to multiparous women who receive usual care, women who receive NFP will have reductions in pregnancy-related hypertension and tobacco use.

Hypothesis 2-Compared to children of women who receive usual care, those whose mothers receive NFP will have improved language development.

Supplemental study hypotheses:

Hypothesis 1: maternal NFP participation causes DNAm variation at glucocorticoid-sensitive sites across the genome at birth, controlling for genetic ancestry

Hypothesis 2: NFP participation reduces DNAm age acceleration from birth to 12 months of age, controlling for genetic variation.

Hypothesis 3: Glucocorticoid-sensitive DNAm and epigenetic aging in offspring measured across infancy (birth to 12 months) will correlate with infant development at 12 months.

Women will be asked to participate in four data collection episodes at study enrollment/baseline (prior to 36 weeks gestation), 6 to 8 weeks postpartum, and child ages 6 and 9 months, and (if consented), to an additional visit at child age 12 months for the supplemental DNAm study.

Researchers will use the following data sources for this study: 1) data routinely collected by the NFP team to determine enrollment and engagement in the NFP program of study participants randomized to NFP; 2) self-administered and interview surveys of study participants collected by the research assistant; 3) formal observation-based assessment tools (such as the Bayley assessment of child development) administered by the research assistant; 4) videos of parent-child interactions recorded by the research assistant and coded by parenting experts; 5) data from medical record review of mothers and their children; 6) birth certificate data; 7) buccal cell samples (infants) collected by the research assistant or self-collected by the participant with guidance from the research assistant.

The research assistants will conduct all the primary data collection from mother-child dyads who have agreed to participate in the trial, and primary data collection will be separate from NFP program delivery which will be conducted by the NFP nurses. Primary data collection will occur at 4 time points as described above. Primary data collection will occur in the participants' homes or at another location where the participant and research assistant feel comfortable (such as a meeting room in a public library). The majority of measures could be collected in a variety of settings with the exception of the video-taped interactions between parents and children which would ideally occur in the child's natural environment. The post partum and 6 month visits only involve maternal report measures and can be conducted by telephone/video using online surveys, unless the participant consents to the cheek swab at the post partum visit, which would be collected in-person.

The research assistant will record where each data collection episode occurred. The research assistant will also record all attempts made to contact study participants for data collection and missed episodes of data collection (i.e., if a visit were arranged and the participant were not available). The research assistant will be trained regarding appropriate collection, transport, and storage procedures for biologic samples and will be trained to conduct the Bayley assessment of child development.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. pregnant at 32 weeks EGA or less
2. history of previous live birth
3. covered by Medicaid or Medicaid-eligible
4. 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).

Exclusion Criteria:

1. unable converse and demonstrate adequate understanding to provide consent for study participation in English or Spanish
2. are already enrolled in a home-visiting intervention with this pregnancy
3. have previously been enrolled in NFP
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention (NFP); 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.	Behavioral: Nurse Family Partnership; During NFP visits, the nurse: 1) engages in a therapeutic nurse-client relationship focused on promoting client abilities and behavior change to protect and promote her own health and child's health; 2) provides service coordination based on client's identified needs, referring to available community services; 3) follows NFP Visit Guidelines tailoring them to the strengths and challenges of each family; 4) works with client to support a healthy pregnancy by recognizing and reducing risk factors and promoting prenatal health care, healthy diet, exercise, and stress management; and 5) gathers data on program implementation and maternal and child health. The visits include content from six domains: personal health, environmental health, life-course, maternal role, family and friends, and health and human services. Nurses use educational materials to address the content from the six domains with their clients.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Pregnancy-related hypertension	High Blood Pressure associated with pregnancy	Birth of index child
Change in maternal tobacco use by cotinine	Measured by cotinine level in saliva	Less than 28 weeks gestation and 36 weeks gestation
Change in self reported maternal tobacco use	Measured by self-report (yes/no)	Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
Index child language development measured by the Bayley IV language subscale	Scaled, age-adjusted score from 1-19 with 19 being best outcome	Index child age 12 months
Index child language development measured by the Peabody Picture Vocabulary Test	Percentage out of 100; 100 being best outcome	Index child age 9 months
DNA methylation biomarkers	Epigenetic age and glucocorticoid-sensitive DNA methylation score from methylation array data	Within 6 weeks of index birth (postpartum) and child age 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with infection during pregnancy based on medical record review	Receipt of screening for common infections; if positive, receipt of appropriate treatment	Index child age 1 month
Number of infants born with weight less than 2500 grams per medical record review		Index child age 1 month
Number of infants born less than 34 weeks gestation per medical record review		Index child age 1 month
Change in self-reported maternal substance use	Past month use per self-report (yes/no)	Less than 36 weeks gestation, within 6 weeks of index birth (postpartum), index child age 6 months, 9 months
Initiation and continuation of any breastfeeding per maternal report	Maternal report of any breastfeeding	Index child age 1 month, 6 months
Percentage of well-child visits attended for index child per medical record review	Number out of 6 visits by 9 months	Index child age 9-12 months
Index child immunization use per medical record review	Immunizations up-to-date for age at 9 months	Record review at index child age 9-12 months
Index child emergency room visits for serious preventable injuries and sentinel injuries for child abuse.	Visit rate and reason for visit per medical record review	Index child age birth to 9 months, Record review at index child age 9-12 months
Index child hospitalization for injuries	Number of days hospitalized for injury per medical record review	Record review at index child age 9-12 months
Change in quality of home environment measured by the HOME (Home Observation Measurement of the Environment) Inventory short form	53 yes/no measures; score scaled based on child age, self-report and interviewer observation	36 weeks gestation, index child age 6 months
Change in quality of home environment measured by the CHAOS (Confusion, Hubbub and Order Scale) Scale	On a scale of 1-15, The higher the score the higher the level of environmental chaos in the home	36 weeks gestation, index child age 6 months
Mother-child interaction measured by the Dyadic Assessment of Naturalistic Caregiver-child Experiences (DANCE)	Video recorded interactions are scored by trained research assistants, for each behavior the frequency and proportion of time spent is recorded.	Index child age 9 months
Child's developmental index measured by Bayley IV developmental assessment	Scaled, age-adjusted score from 1-19 with 19 being best outcome	Index child age 12 months
Index child's social and emotional development based on Bayley IV socio-emotional subscale	Scaled, age-adjusted score from 1-19 with 19 being best outcome	Index child age 12 months
Index child's social and emotional development measured by the Child Behavior Checklist (CBCL) (maternal report)	54 question scored on a scale of 0-2; lower scores are more emotionally regulated children	Index child age 6 months
Change in maternal perceived stress measured by Perceived Stress Scale (maternal report)	Scale of 0-40 based on 10 questions; 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.	Less than 36 weeks gestation and index child age 6 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Yale University; Columbia University; Nationwide Children's Hospital; University of Rochester
• Investigators: Principal Investigator: Mandy A Allison, MD, MSPH, University of Colorado School of Medicine; Principal Investigator: Deena Chisolm, PhD, Nationwide Children's Hospital

Publications and helpful links

General Publications

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• Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9. doi: 10.1542/peds.2004-0962.
• Kitzman H, Olds DL, Sidora K, Henderson CR Jr, Hanks C, Cole R, Luckey DW, Bondy J, Cole K, Glazner J. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000 Apr 19;283(15):1983-9. doi: 10.1001/jama.283.15.1983.
• Kitzman H, Olds DL, Henderson CR Jr, Hanks C, Cole R, Tatelbaum R, McConnochie KM, Sidora K, Luckey DW, Shaver D, Engelhardt K, James D, Barnard K. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997 Aug 27;278(8):644-52.
• Olds DL, Eckenrode J, Henderson CR Jr, Kitzman H, Powers J, Cole R, Sidora K, Morris P, Pettitt LM, Luckey D. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997 Aug 27;278(8):637-43.
• Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the life-course development of socially disadvantaged mothers: a randomized trial of nurse home visitation. Am J Public Health. 1988 Nov;78(11):1436-45. doi: 10.2105/ajph.78.11.1436.
• Olds DL, Henderson CR Jr, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.
• Bowlby J. Attachment and loss: retrospect and prospect. Am J Orthopsychiatry. 1982 Oct;52(4):664-678. doi: 10.1111/j.1939-0025.1982.tb01456.x. No abstract available.
• Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CR Jr, Holmberg J, Tutt RA, Stevenson AJ, Bondy J. Effects of nurse home visiting on maternal and child functioning: age-9 follow-up of a randomized trial. Pediatrics. 2007 Oct;120(4):e832-45. doi: 10.1542/peds.2006-2111.
• Evans GW, Gonnella C, Marcynyszyn LA, Gentile L, Salpekar N. The role of chaos in poverty and children's socioemotional adjustment. Psychol Sci. 2005 Jul;16(7):560-5. doi: 10.1111/j.0956-7976.2005.01575.x.
• Olds D, Henderson CR Jr, Cole R, Eckenrode J, Kitzman H, Luckey D, Pettitt L, Sidora K, Morris P, Powers J. Long-term effects of nurse home visitation on children's criminal and antisocial behavior: 15-year follow-up of a randomized controlled trial. JAMA. 1998 Oct 14;280(14):1238-44. doi: 10.1001/jama.280.14.1238.
• Bor J, Cohen GH, Galea S. Population health in an era of rising income inequality: USA, 1980-2015. Lancet. 2017 Apr 8;389(10077):1475-1490. doi: 10.1016/S0140-6736(17)30571-8.
• Freudenberg N, Ruglis J. Reframing school dropout as a public health issue. Prev Chronic Dis. 2007 Oct;4(4):A107. Epub 2007 Sep 15.
• Wang E, Glazer KB, Howell EA, Janevic TM. Social Determinants of Pregnancy-Related Mortality and Morbidity in the United States: A Systematic Review. Obstet Gynecol. 2020 Apr;135(4):896-915. doi: 10.1097/AOG.0000000000003762.
• Cheng TL, Johnson SB, Goodman E. Breaking the Intergenerational Cycle of Disadvantage: The Three Generation Approach. Pediatrics. 2016 Jun;137(6):e20152467. doi: 10.1542/peds.2015-2467. Epub 2016 May 9.
• Noble KG, Houston SM, Brito NH, Bartsch H, Kan E, Kuperman JM, Akshoomoff N, Amaral DG, Bloss CS, Libiger O, Schork NJ, Murray SS, Casey BJ, Chang L, Ernst TM, Frazier JA, Gruen JR, Kennedy DN, Van Zijl P, Mostofsky S, Kaufmann WE, Kenet T, Dale AM, Jernigan TL, Sowell ER. Family income, parental education and brain structure in children and adolescents. Nat Neurosci. 2015 May;18(5):773-8. doi: 10.1038/nn.3983. Epub 2015 Mar 30.
• Noble KG, Engelhardt LE, Brito NH, Mack LJ, Nail EJ, Angal J, Barr R, Fifer WP, Elliott AJ; PASS Network. Socioeconomic disparities in neurocognitive development in the first two years of life. Dev Psychobiol. 2015 Jul;57(5):535-51. doi: 10.1002/dev.21303. Epub 2015 Mar 30.
• Brito NH, Noble KG. Socioeconomic status and structural brain development. Front Neurosci. 2014 Sep 4;8:276. doi: 10.3389/fnins.2014.00276. eCollection 2014.
• Bradley RH, Corwyn RF. Socioeconomic status and child development. Annu Rev Psychol. 2002;53:371-99. doi: 10.1146/annurev.psych.53.100901.135233.
• Falk-Rafael A. Advancing nursing theory through theory-guided practice: the emergence of a critical caring perspective. ANS Adv Nurs Sci. 2005 Jan-Mar;28(1):38-49. doi: 10.1097/00012272-200501000-00005.
• Olds DL, Kitzman HJ, Cole RE, Hanks CA, Arcoleo KJ, Anson EA, Luckey DW, Knudtson MD, Henderson CR Jr, Bondy J, Stevenson AJ. Enduring effects of prenatal and infancy home visiting by nurses on maternal life course and government spending: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):419-24. doi: 10.1001/archpediatrics.2010.49.
• Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817.
• Fraser JA, Armstrong KL, Morris JP, Dadds MR. Home visiting intervention for vulnerable families with newborns: follow-up results of a randomized controlled trial. Child Abuse Negl. 2000 Nov;24(11):1399-429. doi: 10.1016/s0145-2134(00)00193-9.
• Alonso-Marsden S, Dodge KA, O'Donnell KJ, Murphy RA, Sato JM, Christopoulos C. Family risk as a predictor of initial engagement and follow-through in a universal nurse home visiting program to prevent child maltreatment. Child Abuse Negl. 2013 Aug;37(8):555-65. doi: 10.1016/j.chiabu.2013.03.012. Epub 2013 May 6.
• Duggan A, Caldera D, Rodriguez K, Burrell L, Rohde C, Crowne SS. Impact of a statewide home visiting program to prevent child abuse. Child Abuse Negl. 2007 Aug;31(8):801-27. doi: 10.1016/j.chiabu.2006.06.011. Epub 2007 Sep 5.
• DuMont K, Mitchell-Herzfeld S, Greene R, Lee E, Lowenfels A, Rodriguez M, Dorabawila V. Healthy Families New York (HFNY) randomized trial: effects on early child abuse and neglect. Child Abuse Negl. 2008 Mar;32(3):295-315. doi: 10.1016/j.chiabu.2007.07.007.
• Swain JE, Kim P, Spicer J, Ho SS, Dayton CJ, Elmadih A, Abel KM. Approaching the biology of human parental attachment: brain imaging, oxytocin and coordinated assessments of mothers and fathers. Brain Res. 2014 Sep 11;1580:78-101. doi: 10.1016/j.brainres.2014.03.007. Epub 2014 Mar 15.
• Miller TR. Projected Outcomes of Nurse-Family Partnership Home Visitation During 1996-2013, USA. Prev Sci. 2015 Aug;16(6):765-77. doi: 10.1007/s11121-015-0572-9.
• Bandura A. Self-efficacy: The exercise of control. Macmillan; 1997 Feb 15.
• Bandura A. Social foundations of thought and action. Englewood Cliffs, NJ. 1986;1986(23-28):2.
• Duncan GJ, Dowsett CJ, Claessens A, Magnuson K, Huston AC, Klebanov P, Pagani LS, Feinstein L, Engel M, Brooks-Gunn J, Sexton H, Duckworth K, Japel C. School readiness and later achievement. Dev Psychol. 2007 Nov;43(6):1428-1446. doi: 10.1037/0012-1649.43.6.1428.
• Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the delivery of prenatal care and outcomes of pregnancy: a randomized trial of nurse home visitation. Pediatrics. 1986 Jan;77(1):16-28.

Helpful Links

• McIntosh K, Moss, E., Nunn, R., and Shambaugh, J. Examining the Black-white wealth gap. The Brookings Institute. https://www.brookings.edu/blog/up-front/2020/02/27/examining-the-black-white-wealth-gap/. Published 2020. Accessed2020.
• Darity Jr. W, Hamilton, D., Paul, M., Aja, A., Price, A., Moore, A., and Chiopris, C. What We Get Wrong About Closing the Racial Wealth Gap. Samuel DuBois Cook Center on Social Equality, Insight Center for Community Economic Development.
• Hart B, Risley TR. The early catastrophe. EDUCATION REVIEW-LONDON-. 2003;17(1):110-118.
• Nurse-Family Partnership: A nurse home visitation program for low-income, pregnant women. Social Programs that Work. Prenatal/Early Childhood. . https://evidencebasedprograms.org/policy_area/prenatal-earlychildhood/. Published 2019. Accessed 6/12/2019.
• Effectiveness HVEo. What is Home Visiting Evidence of Effectiveness? U.S. Department of Health and Human Serivces: Administration for Children and Families. https://homvee.acf.hhs.gov/. Published 2020. Accessed2020.
• Haskins R, Paxson, C., Brooks-Gunn, J. Social Science Rising: A Tale of Evidence Shaping Public Policy. Princeton, Brookings. ;2009.
• Braveman PE, S. . Overcoming Obstacles to Health in 2013 and Beyond. RQJF Commission to Build a Healthier America https://www.rwjf.org/en/library/research/2013/06/overcoming-obstacles-to-health-in-2013-and-beyond.html. Published 2013. Accessed2019.

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Home Visiting; Nurse Family Partnership
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 20-0470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share de-identified individual participant data with researchers who desire to conduct additional analyses. Investigators who are interested in accessing de-identified individual participant data should e-mail the Prevention Research Center for Family and Child Health (FamilyChildPRC@cuanschutz.edu) to request an application for data use. The leadership team at the PRC (Prevention Research Center for Family and Child Health) will review the application and determine whether to grant access. The criteria are listed below under 'Access Criteria'.
• IPD Sharing Time Frame: Data will become available at the close of currently funded study (January 2027) and will be available for 10 years (through December 2036).

IPD Sharing Access Criteria

Criteria used in the review are as follows:

1. Proposal has reasonable scientific merit; allows data to be put to good scientific use. Proposal is both theoretically and empirically sound.

   1. Statistical power is appropriate given level of project
   2. Likely usefulness for investigator.
   3. Likely to contribute to existing knowledge base
2. Investigator's collaborator should be associated with our team. They provide link to our team, may provide access to data or at least communicate what data are available.
3. Proposed analyses have not already been completed or proposed by other collaborators or members of the research team.

4. Demands on current staff time are minimal including:

   1. Variable construction
   2. Statistical consultation
   3. Providing computer access/resources
   4. Data cleaning
   5. Providing access to data
   6. Current load of staff, including existing outside projects

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No