Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease

Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease: 29-year Follow-Up of a Randomized Clinical Trial

This study is a longitudinal cohort study that follows participants in a randomized clinical trial of a program of prenatal and early child home visiting on maternal and offspring risks for chronic disease.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Behavioral: Transportation and Developmental Screening; Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy

Detailed Description

Addressing the unacceptably high rates of chronic disease and premature mortality among low-income African Americans (AA) is a public health imperative. The proposed study addresses this challenge by building upon decades of follow-up of low-income, primarily AA participants in a randomized clinical trial of the Nurse-Family Partnership (NFP), a program of prenatal and infant/toddler nurse home visiting for low-income mothers with no previous live births. It examines NFP effects on risks for cardiovascular disease (CVD), type 2 diabetes (T2D), and chronic kidney disease (CKD), as well as premature mortality among both mothers and their first-born offspring at offspring age 30. It is the first adequately powered study of a very early intervention to examine risks for chronic disease and mortality, assessing both mothers and their first-born offspring.

Please note that for this section of the longitudinal study, just the outcome measures for 30 years after delivery are being measured. The study team also measured these outcome measures at baselines, 12 years, and 18 years after delivery in other studies, but for this specific study, the time frame for the listed outcome measures is 30 years after delivery.

• Study Type: Interventional
• Enrollment (Actual): 1055
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mothers who participated in a randomized clinical trial of nurse home visiting and their first-born offspring.
• Women < 29 weeks pregnant --> No previous live births
• No specific chronic illnesses thought to contribute to fetal growth retardation or preterm delivery
• At least two of the following sociodemographic risk conditions: unmarried, less than 12 years of education, and unemployed

Exclusion Criteria:

• Participants who refused assessments at earlier phases of data gathering.
• Women > 29 weeks pregnant
• Previous live births
• Possessing chronic illnesses like hypertensive disorders requiring medical treatment, severe cardiac disease, large uterine fibroids.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1. Transportation and Screening; Free transportation for scheduled prenatal care, developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.	Behavioral: Transportation and Developmental Screening; Arm 1. Transportation and Screening The 514 families in this condition received: 1) free transportation for scheduled prenatal care; and 2) developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.
Experimental: Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy; Free transportation for scheduled prenatal care; intensive nurse home-visitation services during pregnancy and through the child's second birthday; and developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.	Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy; Arm 2. Transportation, Screening, and Nurse-Visitiation During Pregnancy and Infancy The 228 families in this condition received: 1) free transportation for scheduled prenatal care; 2) intensive nurse home-visitation services during pregnancy and through the child's second birthday; and 3) developmental screening and referral services for the child at the 6th, 12th, and 24th months of the child's life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height (standing)	Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece	Approximately 30 years after delivery
Weight	weight measured in pounds	Approximately 30 years after delivery
Waist circumference	waist circumference measured in cm, after exhaling, just above iliac crest, using a non-stretchable cloth measuring tape.	once, approximately 30 years after delivery.
Hip circumference	hip circumference measured in cm, at point of greatest protrusion of gluteal muscles, using a non-stretchable cloth.	once, approximately 30 years after delivery
Percent total body fat	Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer	once, approximately 30 years after delivery
% body fat in arms, legs	Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer	once, approximately 30 years after delivery
Visceral (trunk) fat	Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer	once, approximately 30 years after delivery
Total Cholesterol (TC), High density lipoprotein (HDL), Low density lipoprotein (LDL)	TC, HDL, and LDL are measured by a clinical laboratory from serum samples by Medpace Laboratories.	once, approximately 30 years after delivery
Triglycerides	Measured by a clinical laboratory from serum samples by Medpace Laboratories	once, approximately 30 years after delivery
Glycosylated hemoglobin	Measured by a clinical laboratory from whole blood samples by Medpace Laboratories	once, approximately 30 years after delivery
Insulin-like growth factor 1 (IGF-1)	IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.	once, approximately 30 years after delivery
Follicle-Stimulating Hormone (FSH)	FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.	once, approximately 30 years after delivery
Urine-Albumin	URINE albumin is measured by Medpace Laboratories	once, approximately 30 years after delivery
Urine Creatinine	Urine creatinine is measured in urine by Medpace Laboratories.	once, approximately 30 years after delivery
Estimated Glomerular Filtration Rate (eGFR)	eGFR (estimated glomerular filtration rate) is calculated based on serum creatinine value, age, and gender; measured by Medpace Laboratories.	once, approximately 30 years after delivery
High sensitivity C-reactive protein (hs CRP)	hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.	once, approximately 30 years after delivery
Interleukin-6 (IL-6)	IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.	once, approximately 30 years after delivery
Tumor Necrosis Factor alpha receptor 2	Tumor Necrosis Factor alpha receptor 2 (TNF alpha receptor 2) is measured in serum by Medpace Laboratories. This is an inflammatory marker.	once, approximately 30 years after delivery
Fibrinogen	Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.	once, approximately 30 years after delivery
Resting blood pressure (diastolic)	Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.	once, approximately 30 years after delivery
Resting blood pressure (systolic)	Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.	once, approximately 30 years after delivery
Carotid to femoral pulse wave velocity (cf-PWV)	Pulse wave velocity is a measure of arterial stiffness. It is a predictor of cardiovascular risk. It is measured using the SphygmoCor XCEL instrument.	once, approximately 30 years after delivery
Augmentation index	Augmentation Index is a measure of arterial stiffness. It is calculated as the ratio of Augmented Pressure to Pulse pressure. a predictor of cardiovascular risk. It is measured using the SphygmoCor SCEL instrument	once, approximately 30 years after delivery
Mortality - Mothers	The study team expects the intervention to reduce the rates of all-cause mortality among mothers given that death is more likely among those with COVID infections who have underlying chronic conditions. Moreover, the study team expects the program to reduce mortality for chronic diseases and CVD among mothers if the rates are sufficiently high to detect such differences.	measured once, approximately 30 years after delivery.
Mortality - Offspring	Among offspring, those who become infected with COVID are less likely to die than their mothers, given that their underlying chronic conditions are less likely to be as serious or prevalent. Therefore, the investigators expect the treatment-control differences to be limited to external causes. Note that in the original proposal the authors had included deaths due preventable causes (SIDS) as operationalized in a recent publication: https://pubmed.ncbi.nlm.nih.gov/34420828/. Given the controversy that has emerged in recent years about whether the causes of SIDS are uniformly preventable, SIDS was added to a modified version of this outcome that includes external cuases, that will be analyzed as an exploratory outcome in examining offspring mortality. The authors also will conduct an exploratory analysis of all-cause mortality.	measured once, approximately 30 years after delivery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical diagnoses, signs, and symptoms	Obtained via medical history interview by trained nurses.	interview conducted approximately 30 years after delivery
Current medications	Obtained via medical history interview by trained nurses.	interview conducted approximately 30 years after delivery
Number of Hospitalizations per participant (mental/behavioral)	Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.	interview conducted approximately 30 years after delivery
Number of Hospitalizations per participant (medical/surgical)	Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.	interview conducted approximately 30 years after delivery
Disability (injury)	obtained from 1) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security Income.	interview conducted approximately 30 years after delivery
Disability (physical)	1) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security.	interview conducted approximately 30 years after delivery
Disability (mental illness)	1) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security Income.	interview conducted approximately 30 years after delivery
Number of pregnancies	Self-reports of all pregnancies and dates	interview conducted approximately 30 years after delivery
Pregnancy losses	self-reports of all pregnancies not resulting in a live birth	interview conducted approximately 30 years after delivery
Number of live births	1) self-reports of all children's dates of births and 2) administrative data	interview conducted approximately 30 years after delivery
Pregnancy complications	derived from administrative (birth certificate) data	interview conducted approximately 30 years after delivery
Birthweight	determined through a combination of interview and administrative (birth certificate) data	interview conducted approximately 30 years after delivery
Gestational age	determined through a combination of interview and administrative (birth certificate) data	interview conducted approximately 30 years after delivery
Menopause (age)	Determined via interview	interview conducted approximately 30 years after delivery
Self-rated health	Excellent, very good, good, fair, or poor	interview conducted approximately 30 years after delivery
Physical activity - Total Metabolic Equivalent of Task (MET) minutes per week	International Physical Activity Questionnaire (IPAQ): questionnaire to obtain internationally comparable data regarding physical activity. Questions ask about quantity and duration of physical activity.	interview conducted approximately 30 years after delivery
Sleep Quality -- Global Score	Derived from Pittsburgh Sleep Quality Index (PSQI): questions on the PSQI are rated on a scale of 0-3, 0 = no difficulty to 3 = severe difficulty, and ask questions related to sleep latency, sleep duration, sleep disturbances, use of sleep medication,and daytime dysfunction.	interview conducted approximately 30 years after delivery
Average daily fruit and vegetable intake	derived from Diet NIH Eating at America's Table: All-Day Fruit & vegetable Screener	interview conducted approximately 30 years after delivery
Percent energy from fat	Derived from National Cancer Institute Percentage Energy from Fat Screener	interview conducted approximately 30 years after delivery
Dietary restraint/eating patterns	Derived from Three Factor Eating Questionnaire: Measures three aspects of eating behaviors: cognitive restraint, uncontrolled eating, and emotional eating.	interview conducted approximately 30 years after delivery
Screening for Substance Use - TAPS 1 (tobacco, alcohol, prescription medication, and other substance use)	use of substances in the past three months	interview conducted approximately 30 years after delivery
Substance Use Risk Level TAPS 2	Risk category: no use in past 3 months, problem use, higher risk Substance Use Dependence	interview conducted approximately 30 years after delivery
Tobacco: Cigarettes	Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day	interview conducted approximately 30 years after delivery
Tobacco: Cigars	Ever smoked cigars, aged started and stopped, number of cigars per week	interview conducted approximately 30 years after delivery
Tobacco: Pipe, Hookah	Ever smoke tobacco in pipe or hookah, age started and stopped, number of pipe bowls per week	interview conducted approximately 30 years after delivery
Tobacco: Smokeless Tobacco Snus	Ever used Snus, age started and stopped, number of snus pouches per week	interview conducted approximately 30 years after delivery
Other Smokeless Tobacco (dip, chewing tobacco)	: Ever used dip, chewing tobacco, age started and stopped, number of times per day	interview conducted approximately 30 years after delivery
Tobacco: Electronic Nicotine Products	Ever used, age started and stopped, number of times per day	interview conducted approximately 30 years after delivery
Depression	Derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8a Adult: measures patient-reported outcomes like pain, fatigue, physical functioning, emotional distress, and social role participation.Each question uses a 5-point ordinal scale of "never," "rarely," sometimes," "often," and "always." Higher scores indicate higher depression severity.	interview conducted approximately 30 years after delivery
Anxiety	Derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a Adult. 7 Questions about feelings related to anxiety felt in the past seven days. Each question uses a 5-point ordinal scale of "never," "rarely," sometimes," "often," and "always." Higher scores indicate higher anxiety severity.	interview conducted approximately 30 years after delivery
Mastery	Derived from Pearlin Mastery Scale. Measured on a 4 point Likert Scale, (1: Strongly Disagree, 4: Strongly agree). Scores can range from 7-28, with higher scores indicating a higher level of mastery.	interview conducted approximately 30 years after delivery
Duration of Marriage and partnered relationships	List of current and previous married and partnered relationships, length of time together.	interview conducted approximately 30 years after delivery
Relationship Commitment: Current Relationship	Structural commitment (dating, cohabitating, married)	interview conducted approximately 30 years after delivery
Relationship Personal Commitment: Current Relationship	not at all committed to extremely committed relationship: 2 indicators of committment: structural and personal commitment. Personal commitment responses: 1-4, 1: not very committed, to 4: extremely committed.	interview conducted approximately 30 years after delivery
Relationship Satisfaction: Current Relationship	Overall happiness with relationship and satisfaction with partner: assessed with 2 questions regarding overall happiness and partner satisfaction.	interview conducted approximately 30 years after delivery
Partner Warmth Index: Current Relationship	Degree to which partner displayed warm behaviors: 3 questions regarding how often their partner displayed warm behaviors in the past month, ranging from 1-4. 1: never to 4: always.	interview conducted approximately 30 years after delivery
Partner Hostility Index: Current Relationship	Degree to which partner displayed hostile behaviors: 5 questions asking about partner hostile behavior in past month, ranging from 1-4. 1: never, 4: always	interview conducted approximately 30 years after delivery
Educational attainment (High School)	High school education: graduated from high school, obtained General Education Development (GED), left high school without completing.	interview conducted approximately 30 years after delivery
Educational attainment (College)	Highest Degree completed: Associates, Bachelors, Masters, PhD.	interview conducted approximately 30 years after delivery
Educational attainment (job training)	Dates and types of job training programs	interview conducted approximately 30 years after delivery
Current work status (job)	List of employment, duties, dates of employment	interview conducted approximately 30 years after delivery
Current work status (hours/week)	number of hours work per week	interview conducted approximately 30 years after delivery
Arrests and Incarceration	Dates and outcomes of arrests	interview conducted approximately 30 years after delivery
Arrests	Types of arrests: misdemeanor, felony	interview conducted approximately 30 years after delivery
Arrests and incarceration	number of days incarcerated	interview conducted approximately 30 years after delivery

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of Rochester; Medpace, Inc.

Publications and helpful links

General Publications

• MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. doi: 10.1037/1082-989x.7.1.83.
• Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982 Dec;38(4):963-74.
• Menke A, Casagrande S, Geiss L, Cowie CC. Prevalence of and Trends in Diabetes Among Adults in the United States, 1988-2012. JAMA. 2015 Sep 8;314(10):1021-9. doi: 10.1001/jama.2015.10029.
• Danese A, Moffitt TE, Harrington H, Milne BJ, Polanczyk G, Pariante CM, Poulton R, Caspi A. Adverse childhood experiences and adult risk factors for age-related disease: depression, inflammation, and clustering of metabolic risk markers. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1135-43. doi: 10.1001/archpediatrics.2009.214.
• Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.
• Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
• Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. doi: 10.1542/peds.2004-0961.
• Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.
• Kajantie E, Eriksson JG, Osmond C, Thornburg K, Barker DJ. Pre-eclampsia is associated with increased risk of stroke in the adult offspring: the Helsinki birth cohort study. Stroke. 2009 Apr;40(4):1176-80. doi: 10.1161/STROKEAHA.108.538025. Epub 2009 Mar 5.
• Subar AF, Thompson FE, Kipnis V, Midthune D, Hurwitz P, McNutt S, McIntosh A, Rosenfeld S. Comparative validation of the Block, Willett, and National Cancer Institute food frequency questionnaires : the Eating at America's Table Study. Am J Epidemiol. 2001 Dec 15;154(12):1089-99. doi: 10.1093/aje/154.12.1089.
• Bull FC, Maslin TS, Armstrong T. Global physical activity questionnaire (GPAQ): nine country reliability and validity study. J Phys Act Health. 2009 Nov;6(6):790-804. doi: 10.1123/jpah.6.6.790.
• Mor G, Cardenas I. The immune system in pregnancy: a unique complexity. Am J Reprod Immunol. 2010 Jun;63(6):425-33. doi: 10.1111/j.1600-0897.2010.00836.x. Epub 2010 Mar 29.
• 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.
• Sanghavi M, Rutherford JD. Cardiovascular physiology of pregnancy. Circulation. 2014 Sep 16;130(12):1003-8. doi: 10.1161/CIRCULATIONAHA.114.009029. No abstract available.
• 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, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.
• 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.
• 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.
• Eckenrode J, Campa M, Luckey DW, Henderson CR Jr, Cole R, Kitzman H, Anson E, Sidora-Arcoleo K, Powers J, Olds D. Long-term effects of prenatal and infancy nurse home visitation on the life course of youths: 19-year follow-up of a randomized trial. Arch Pediatr Adolesc Med. 2010 Jan;164(1):9-15. doi: 10.1001/archpediatrics.2009.240. Erratum In: Arch Pediatr Adolesc Med. 2010 May;164(5):424.
• Loveman E, Al-Khudairy L, Johnson RE, Robertson W, Colquitt JL, Mead EL, Ells LJ, Metzendorf MI, Rees K. Parent-only interventions for childhood overweight or obesity in children aged 5 to 11 years. Cochrane Database Syst Rev. 2015 Dec 21;2015(12):CD012008. doi: 10.1002/14651858.CD012008.
• Daniels SR, Pratt CA, Hollister EB, Labarthe D, Cohen DA, Walker JR, Beech BM, Balagopal PB, Beebe DW, Gillman MW, Goodrich JM, Jaquish C, Kit B, Miller AL, Olds D, Oken E, Rajakumar K, Sherwood NE, Spruijt-Metz D, Steinberger J, Suglia SF, Teitelbaum SL, Urbina EM, Van Horn L, Ward D, Young ME. Promoting Cardiovascular Health in Early Childhood and Transitions in Childhood through Adolescence: A Workshop Report. J Pediatr. 2019 Jun;209:240-251.e1. doi: 10.1016/j.jpeds.2019.01.042. Epub 2019 Mar 20. No abstract available.
• 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.
• 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.
• Carnethon MR, Pu J, Howard G, Albert MA, Anderson CAM, Bertoni AG, Mujahid MS, Palaniappan L, Taylor HA Jr, Willis M, Yancy CW; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; and Stroke Council. Cardiovascular Health in African Americans: A Scientific Statement From the American Heart Association. Circulation. 2017 Nov 21;136(21):e393-e423. doi: 10.1161/CIR.0000000000000534. Epub 2017 Oct 23.
• United States Renal Data System. 2014 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases: Bethesda, MD, 2014.
• Havranek EP, Mujahid MS, Barr DA, Blair IV, Cohen MS, Cruz-Flores S, Davey-Smith G, Dennison-Himmelfarb CR, Lauer MS, Lockwood DW, Rosal M, Yancy CW; American Heart Association Council on Quality of Care and Outcomes Research, Council on Epidemiology and Prevention, Council on Cardiovascular and Stroke Nursing, Council on Lifestyle and Cardiometabolic Health, and Stroke Council. Social Determinants of Risk and Outcomes for Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 1;132(9):873-98. doi: 10.1161/CIR.0000000000000228. Epub 2015 Aug 3. No abstract available.
• Pool LR, Ning H, Lloyd-Jones DM, Allen NB. Trends in Racial/Ethnic Disparities in Cardiovascular Health Among US Adults From 1999-2012. J Am Heart Assoc. 2017 Sep 22;6(9):e006027. doi: 10.1161/JAHA.117.006027.
• Bancks MP, Kershaw K, Carson AP, Gordon-Larsen P, Schreiner PJ, Carnethon MR. Association of Modifiable Risk Factors in Young Adulthood With Racial Disparity in Incident Type 2 Diabetes During Middle Adulthood. JAMA. 2017 Dec 26;318(24):2457-2465. doi: 10.1001/jama.2017.19546.
• Signorello LB, Schlundt DG, Cohen SS, Steinwandel MD, Buchowski MS, McLaughlin JK, Hargreaves MK, Blot WJ. Comparing diabetes prevalence between African Americans and Whites of similar socioeconomic status. Am J Public Health. 2007 Dec;97(12):2260-7. doi: 10.2105/AJPH.2006.094482. Epub 2007 Oct 30.
• Norton JM, Moxey-Mims MM, Eggers PW, Narva AS, Star RA, Kimmel PL, Rodgers GP. Social Determinants of Racial Disparities in CKD. J Am Soc Nephrol. 2016 Sep;27(9):2576-95. doi: 10.1681/ASN.2016010027. Epub 2016 May 13.
• Stuart-Shor EM, Berra KA, Kamau MW, Kumanyika SK. Behavioral strategies for cardiovascular risk reduction in diverse and underserved racial/ethnic groups. Circulation. 2012 Jan 3;125(1):171-84. doi: 10.1161/CIRCULATIONAHA.110.968495. No abstract available.
• Suglia SF, Koenen KC, Boynton-Jarrett R, Chan PS, Clark CJ, Danese A, Faith MS, Goldstein BI, Hayman LL, Isasi CR, Pratt CA, Slopen N, Sumner JA, Turer A, Turer CB, Zachariah JP; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Childhood and Adolescent Adversity and Cardiometabolic Outcomes: A Scientific Statement From the American Heart Association. Circulation. 2018 Jan 30;137(5):e15-e28. doi: 10.1161/CIR.0000000000000536. Epub 2017 Dec 18.
• Slopen N, Loucks EB, Appleton AA, Kawachi I, Kubzansky LD, Non AL, Buka S, Gilman SE. Early origins of inflammation: An examination of prenatal and childhood social adversity in a prospective cohort study. Psychoneuroendocrinology. 2015 Jan;51:403-13. doi: 10.1016/j.psyneuen.2014.10.016. Epub 2014 Oct 25.
• Loria AS, Ho DH, Pollock JS. A mechanistic look at the effects of adversity early in life on cardiovascular disease risk during adulthood. Acta Physiol (Oxf). 2014 Feb;210(2):277-87. doi: 10.1111/apha.12189. Epub 2013 Dec 13.
• Alexander BT, Dasinger JH, Intapad S. Fetal programming and cardiovascular pathology. Compr Physiol. 2015 Apr;5(2):997-1025. doi: 10.1002/cphy.c140036.
• Brunton PJ, Russell JA. Endocrine induced changes in brain function during pregnancy. Brain Res. 2010 Dec 10;1364:198-215. doi: 10.1016/j.brainres.2010.09.062. Epub 2010 Sep 22.
• Fisher C, MacLean M, Morecroft I, Seed A, Johnston F, Hillier C, McMurray J. Is the pregnancy hormone relaxin also a vasodilator peptide secreted by the heart? Circulation. 2002 Jul 16;106(3):292-5. doi: 10.1161/01.cir.0000025630.05387.45.
• Hoekzema E, Barba-Muller E, Pozzobon C, Picado M, Lucco F, Garcia-Garcia D, Soliva JC, Tobena A, Desco M, Crone EA, Ballesteros A, Carmona S, Vilarroya O. Pregnancy leads to long-lasting changes in human brain structure. Nat Neurosci. 2017 Feb;20(2):287-296. doi: 10.1038/nn.4458. Epub 2016 Dec 19.
• Faraji J, Karimi M, Soltanpour N, Rouhzadeh Z, Roudaki S, Hosseini SA, Jafari SY, Abdollahi AA, Soltanpour N, Moeeini R, Metz GAS. Intergenerational Sex-Specific Transmission of Maternal Social Experience. Sci Rep. 2018 Jul 12;8(1):10529. doi: 10.1038/s41598-018-28729-8.
• Wan L, Tu T, Zhang QL, Jiang J, Yan XX. Pregnancy Promotes Maternal Hippocampal Neurogenesis in Guinea Pigs. Neural Plast. 2019 Apr 11;2019:5765284. doi: 10.1155/2019/5765284. eCollection 2019.
• Barba-Muller E, Craddock S, Carmona S, Hoekzema E. Brain plasticity in pregnancy and the postpartum period: links to maternal caregiving and mental health. Arch Womens Ment Health. 2019 Apr;22(2):289-299. doi: 10.1007/s00737-018-0889-z. Epub 2018 Jul 14.
• Zhang S, Ding Z, Liu H, Chen Z, Wu J, Zhang Y, Yu Y. Association between mental stress and gestational hypertension/preeclampsia: a meta-analysis. Obstet Gynecol Surv. 2013 Dec;68(12):825-34. doi: 10.1097/OGX.0000000000000001.
• Ying W, Catov JM, Ouyang P. Hypertensive Disorders of Pregnancy and Future Maternal Cardiovascular Risk. J Am Heart Assoc. 2018 Sep 4;7(17):e009382. doi: 10.1161/JAHA.118.009382. No abstract available.
• Bergen NE, Schalekamp-Timmermans S, Roos-Hesselink J, Roeters van Lennep JE, Jaddoe VVW, Steegers EAP. Hypertensive disorders of pregnancy and subsequent maternal cardiovascular health. Eur J Epidemiol. 2018 Aug;33(8):763-771. doi: 10.1007/s10654-018-0400-1. Epub 2018 May 19.
• Behrens I, Basit S, Melbye M, Lykke JA, Wohlfahrt J, Bundgaard H, Thilaganathan B, Boyd HA. Risk of post-pregnancy hypertension in women with a history of hypertensive disorders of pregnancy: nationwide cohort study. BMJ. 2017 Jul 12;358:j3078. doi: 10.1136/bmj.j3078.
• Xu J, Barinas-Mitchell E, Kuller LH, Youk AO, Catov JM. Maternal hypertension after a low-birth-weight delivery differs by race/ethnicity: evidence from the National Health and Nutrition Examination Survey (NHANES) 1999-2006. PLoS One. 2014 Aug 5;9(8):e104149. doi: 10.1371/journal.pone.0104149. eCollection 2014.
• Mamun AA, O'Callaghan MJ, Williams GM, Najman JM. Maternal smoking during pregnancy predicts adult offspring cardiovascular risk factors - evidence from a community-based large birth cohort study. PLoS One. 2012;7(7):e41106. doi: 10.1371/journal.pone.0041106. Epub 2012 Jul 19.
• Gaillard R. Maternal obesity during pregnancy and cardiovascular development and disease in the offspring. Eur J Epidemiol. 2015 Nov;30(11):1141-52. doi: 10.1007/s10654-015-0085-7. Epub 2015 Sep 16.
• Mamun AA, Kinarivala MK, O'Callaghan M, Williams G, Najman J, Callaway L. Does hypertensive disorder of pregnancy predict offspring blood pressure at 21 years? Evidence from a birth cohort study. J Hum Hypertens. 2012 May;26(5):288-94. doi: 10.1038/jhh.2011.35. Epub 2011 Apr 21.
• Smith CJ, Ryckman KK, Barnabei VM, Howard BV, Isasi CR, Sarto GE, Tom SE, Van Horn LV, Wallace RB, Robinson JG. The impact of birth weight on cardiovascular disease risk in the Women's Health Initiative. Nutr Metab Cardiovasc Dis. 2016 Mar;26(3):239-45. doi: 10.1016/j.numecd.2015.10.015. Epub 2015 Nov 18.
• Doom JR, Mason SM, Suglia SF, Clark CJ. Pathways between childhood/adolescent adversity, adolescent socioeconomic status, and long-term cardiovascular disease risk in young adulthood. Soc Sci Med. 2017 Sep;188:166-175. doi: 10.1016/j.socscimed.2017.06.044. Epub 2017 Jul 24.
• Gebreab SY, Diez Roux AV, Brenner AB, Hickson DA, Sims M, Subramanyam M, Griswold ME, Wyatt SB, James SA. The impact of lifecourse socioeconomic position on cardiovascular disease events in African Americans: the Jackson Heart Study. J Am Heart Assoc. 2015 May 27;4(6):e001553. doi: 10.1161/JAHA.114.001553.
• Suglia SF, Clark CJ, Boynton-Jarrett R, Kressin NR, Koenen KC. Child maltreatment and hypertension in young adulthood. BMC Public Health. 2014 Nov 6;14:1149. doi: 10.1186/1471-2458-14-1149.
• Garad Y, Maximova K, MacKinnon N, McGrath JJ, Kozyrskyj AL, Colman I. Sex-Specific Differences in the Association Between Childhood Adversity and Cardiovascular Disease in Adulthood: Evidence From a National Cohort Study. Can J Cardiol. 2017 Aug;33(8):1013-1019. doi: 10.1016/j.cjca.2017.05.008. Epub 2017 May 19.
• Murphy MO, Herald JB, Leachman J, Villasante Tezanos A, Cohn DM, Loria AS. A model of neglect during postnatal life heightens obesity-induced hypertension and is linked to a greater metabolic compromise in female mice. Int J Obes (Lond). 2018 Jul;42(7):1354-1365. doi: 10.1038/s41366-018-0035-z. Epub 2018 Feb 23.
• Wainstock T, Shoham-Vardi I, Glasser S, Anteby E, Lerner-Geva L. Fetal sex modifies effects of prenatal stress exposure and adverse birth outcomes. Stress. 2015 Jan;18(1):49-56. doi: 10.3109/10253890.2014.974153. Epub 2014 Dec 29.
• Barrett ES, Swan SH. Stress and Androgen Activity During Fetal Development. Endocrinology. 2015 Oct;156(10):3435-41. doi: 10.1210/en.2015-1335. Epub 2015 Aug 4.
• Shiozaki A, Matsuda Y, Satoh S, Saito S. Impact of fetal sex in pregnancy-induced hypertension and preeclampsia in Japan. J Reprod Immunol. 2011 May;89(2):133-9. doi: 10.1016/j.jri.2010.12.011. Epub 2011 Apr 22.
• Taylor BD, Ness RB, Klebanoff MA, Tang G, Roberts JM, Hougaard DM, Skogstrand K, Haggerty CL. The impact of female fetal sex on preeclampsia and the maternal immune milieu. Pregnancy Hypertens. 2018 Apr;12:53-57. doi: 10.1016/j.preghy.2018.02.009. Epub 2018 Feb 24.
• Jaskolka D, Retnakaran R, Zinman B, Kramer CK. Fetal sex and maternal risk of pre-eclampsia/eclampsia: a systematic review and meta-analysis. BJOG. 2017 Mar;124(4):553-560. doi: 10.1111/1471-0528.14163. Epub 2016 Jun 17.
• Valdiviezo C, Garovic VD, Ouyang P. Preeclampsia and hypertensive disease in pregnancy: their contributions to cardiovascular risk. Clin Cardiol. 2012 Mar;35(3):160-5. doi: 10.1002/clc.21965.
• Davis EF, Lazdam M, Lewandowski AJ, Worton SA, Kelly B, Kenworthy Y, Adwani S, Wilkinson AR, McCormick K, Sargent I, Redman C, Leeson P. Cardiovascular risk factors in children and young adults born to preeclamptic pregnancies: a systematic review. Pediatrics. 2012 Jun;129(6):e1552-61. doi: 10.1542/peds.2011-3093. Epub 2012 May 21.
• Daniels SR, Pratt CA, Hayman LL. Reduction of risk for cardiovascular disease in children and adolescents. Circulation. 2011 Oct 11;124(15):1673-86. doi: 10.1161/CIRCULATIONAHA.110.016170. No abstract available.
• Van Buren DJ, Tibbs TL. Lifestyle interventions to reduce diabetes and cardiovascular disease risk among children. Curr Diab Rep. 2014 Dec;14(12):557. doi: 10.1007/s11892-014-0557-2.
• Sung-Chan P, Sung YW, Zhao X, Brownson RC. Family-based models for childhood-obesity intervention: a systematic review of randomized controlled trials. Obes Rev. 2013 Apr;14(4):265-78. doi: 10.1111/obr.12000. Epub 2012 Nov 9.
• Campbell F, Conti G, Heckman JJ, Moon SH, Pinto R, Pungello E, Pan Y. Early childhood investments substantially boost adult health. Science. 2014 Mar 28;343(6178):1478-85. doi: 10.1126/science.1248429.
• Brody GH, Yu T, Miller GE, Ehrlich KB, Chen E. Preventive parenting intervention during childhood and young black adults' unhealthful behaviors: a randomized controlled trial. J Child Psychol Psychiatry. 2019 Jan;60(1):63-71. doi: 10.1111/jcpp.12968. Epub 2018 Sep 11.
• Olds DL. Prenatal and infancy home visiting by nurses: from randomized trials to community replication. Prev Sci. 2002 Sep;3(3):153-72. doi: 10.1023/a:1019990432161.
• Kitzman HJ, Olds DL, Cole RE, Hanks CA, Anson EA, Arcoleo KJ, Luckey DW, Knudtson MD, Henderson CR Jr, Holmberg JR. Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):412-8. doi: 10.1001/archpediatrics.2010.76.
• Olds DL, Kitzman H, Knudtson MD, Anson E, Smith JA, Cole R. Effect of home visiting by nurses on maternal and child mortality: results of a 2-decade follow-up of a randomized clinical trial. JAMA Pediatr. 2014 Sep;168(9):800-6. doi: 10.1001/jamapediatrics.2014.472.
• Conti G, Kitzman H, Smith JA, Olds DL. Effects of prenatal/Infancy home visiting on maternal and offspring obesity and blood pressure through age 18. In preparation.
• Grundy E, Kravdal O. Do short birth intervals have long-term implications for parental health? Results from analyses of complete cohort Norwegian register data. J Epidemiol Community Health. 2014 Oct;68(10):958-64. doi: 10.1136/jech-2014-204191. Epub 2014 Jul 9.
• Khatiwada S, Rajendra KC, Gautam S, Lamsal M, Baral N. Thyroid dysfunction and dyslipidemia in chronic kidney disease patients. BMC Endocr Disord. 2015 Oct 29;15:65. doi: 10.1186/s12902-015-0063-9.
• Lawlor DA, Davey Smith G, Whincup P, Wannamethee G, Papacosta O, Dhanjil S, Griffin M, Nicolaides AN, Ebrahim S. Association between offspring birth weight and atherosclerosis in middle aged men and women: British Regional Heart Study. J Epidemiol Community Health. 2003 Jun;57(6):462-3. doi: 10.1136/jech.57.6.462. No abstract available.
• Lawlor DA, Davey Smith G, Ebrahim S. Birth weight of offspring and insulin resistance in late adulthood: cross sectional survey. BMJ. 2002 Aug 17;325(7360):359. doi: 10.1136/bmj.325.7360.359.
• Cronk L. Preferential parental investment in daughters over sons. Hum Nat. 1991 Dec;2(4):387-417. doi: 10.1007/BF02692198.
• Cronk, L. Parental Favoritism toward Daughters. Am Sci. 1993;81(3):272-279.
• Hopcroft, R. Parental status and differential investment in sons and daughters: Trivers-Willard Revisited. Soc Forces. 2005;83(3):1111-1136.
• Gibson MA. Does Investment in the Sexes Differ When Fathers Are Absent? : Sex-biased Infant Survival and Child Growth in Rural Ethiopia. Hum Nat. 2008 Sep;19(3):263-76. doi: 10.1007/s12110-008-9044-2.
• Veloudi P, Sharman JE. Methodological factors affecting quantification of blood pressure variability: a scoping review. J Hypertens. 2018 Apr;36(4):711-719. doi: 10.1097/HJH.0000000000001606.
• Lynch BM, Friedenreich CM, Khandwala F, Liu A, Nicholas J, Csizmadi I. Development and testing of a past year measure of sedentary behavior: the SIT-Q. BMC Public Health. 2014 Sep 1;14:899. doi: 10.1186/1471-2458-14-899.
• Searle SR. Linear models. New York, NY: Wiley;1971.
• McCullagh P, Nelder JA. Generalized linear models. London, England: Chapman and Hall/CRC;1983
• Schall R. Estimation in generalized linear models with random effects. Biometrika 1991;78(4):719-27.
• Russ Wolfinger & Michael O'connell (1993) Generalized linear mixed models a pseudo-likelihood approach, Journal of Statistical Computation and Simulation, 48:3-4, 233-243, DOI: 10.1080/00949659308811554
• Charles R. Henderson Jr & C.R. Henderson (1979) Analysis of covariance in mixed models with unequal subclass numbers, Communications in Statistics - Theory and Methods, 8:8, 751-787, DOI: 10.1080/03610927908827798
• Ruppert D, Wand, MP, Carroll RJ. Semiparametric regression. New York, NY: Cambridge University Press; 2003.
• Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53(282):457-481
• Klein JP. Competing risks. WIREs Comp Stat. 2010;2(3):333-339.
• Gray RJ. A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat. 1988;16(3):1141-54.
• Cox, DR. Regression models and life-tables. J R Stat Soc Series B Stat Methodol. 1972;34(2):187-220.
• Bollen KA. Structural equations with latent variables. New York, NY:Wiley;1989.
• Belloni A, Chernozhukov V, Hansen C. Inference on treatment effects after selection among high-dimensional controls. Rev Econ Stud. 2014;81(2):608-650.
• Bradley Efron. Trevor Hastie. Iain Johnstone. Robert Tibshirani.
• MR Osborne, B Presnell, BA Turlach, A new approach to variable selection in least squares problems, IMA Journal of Numerical Analysis, Volume 20, Issue 3, July 2000, Pages 389-403, https://doi.org/10.1093/imanum/20.3.389
• Little RJA, Rubin DB. Statistical analysis with missing data, 2nd ed. New York, NY:John Wiley and Sons;2002.
• Olds DL, Kitzman H, Anson E, Smith JA, Knudtson MD, Miller T, Cole R, Hopfer C, Conti G. Prenatal and Infancy Nurse Home Visiting Effects on Mothers: 18-Year Follow-up of a Randomized Trial. Pediatrics. 2019 Dec;144(6):e20183889. doi: 10.1542/peds.2018-3889. Epub 2019 Nov 20.
• Cheng, S. The accumulation of (dis)advantage: The intersection of gender and race in the long-term wage effect of marriage. Am Sociol Rev. 2016;81(1):29-56.
• Waite LJ. Does marriage matter? Demography. 1995 Nov;32(4):483-507. No abstract available.
• .Ludwig, V., Brüderl, J. Is there a male marital wage premium? New evidence from the United States. Am Sociol Rev. 2018;83(4):744-770.
• Barr AB, Culatta E, Simons RL. Romantic relationships and health among African American young adults: linking patterns of relationship quality over time to changes in physical and mental health. J Health Soc Behav. 2013;54(3):369-85. doi: 10.1177/0022146513486652. Epub 2013 May 8.
• Grandi SM, Filion KB, Yoon S, Ayele HT, Doyle CM, Hutcheon JA, Smith GN, Gore GC, Ray JG, Nerenberg K, Platt RW. Cardiovascular Disease-Related Morbidity and Mortality in Women With a History of Pregnancy Complications. Circulation. 2019 Feb 19;139(8):1069-1079. doi: 10.1161/CIRCULATIONAHA.118.036748. Erratum In: Circulation. 2019 Aug 27;140(9):e544. doi: 10.1161/CIR.0000000000000718.
• Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. No abstract available.
• 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.
• Cunningham TJ, Croft JB, Liu Y, Lu H, Eke PI, Giles WH. Vital Signs: Racial Disparities in Age-Specific Mortality Among Blacks or African Americans - United States, 1999-2015. MMWR Morb Mortal Wkly Rep. 2017 May 5;66(17):444-456. doi: 10.15585/mmwr.mm6617e1.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Technology, Industry, and Agriculture; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening; Transportation
• Other Study ID Numbers: 20-0794

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators are only sharing IPD among the institutions involved in the conduct of this study.
• IPD Sharing Time Frame: March 1, 2025
• IPD Sharing Access Criteria: check with Nancy about this
• 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