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Chronic DiseaseNCT06160037

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

A study testing Transportation and Developmental Screening and Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy in people with Chronic Disease, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Chronic Disease
What is being tested?
Transportation and Developmental Screening and Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,055 participants
Where
1 siteUnited States
Study dates
20 May 2020to 31 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Chronic Disease
Being tested
Transportation and Developmental Screening, Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
Medical subject headings
Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transportation and Developmental ScreeningBehavioural

    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.

  • Transportation, Screening, and Nurse-Visitation during Pregnancy and InfancyBehavioural

    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.

Study groups in NCT06160037
Study groupRoleWhat they receive
Arm 1. Transportation and ScreeningActive comparatorFree 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.
Receives: Behavioral: Transportation and Developmental Screening
Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and InfancyExperimentalFree 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.
Receives: Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Height (standing)

    Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece

    Measured: Approximately 30 years after delivery

  2. Weight

    weight measured in pounds

    Measured: Approximately 30 years after delivery

  3. Waist circumference

    waist circumference measured in cm, after exhaling, just above iliac crest, using a non-stretchable cloth measuring tape.

    Measured: once, approximately 30 years after delivery.

  4. Hip circumference

    hip circumference measured in cm, at point of greatest protrusion of gluteal muscles, using a non-stretchable cloth.

    Measured: once, approximately 30 years after delivery

  5. Percent total body fat

    Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

    Measured: once, approximately 30 years after delivery

  6. % body fat in arms, legs

    Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

    Measured: once, approximately 30 years after delivery

  7. Visceral (trunk) fat

    Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

    Measured: once, approximately 30 years after delivery

  8. 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.

    Measured: once, approximately 30 years after delivery

  9. Triglycerides

    Measured by a clinical laboratory from serum samples by Medpace Laboratories

    Measured: once, approximately 30 years after delivery

  10. Glycosylated hemoglobin

    Measured by a clinical laboratory from whole blood samples by Medpace Laboratories

    Measured: once, approximately 30 years after delivery

  11. Insulin-like growth factor 1 (IGF-1)

    IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.

    Measured: once, approximately 30 years after delivery

  12. Follicle-Stimulating Hormone (FSH)

    FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.

    Measured: once, approximately 30 years after delivery

  13. Urine-Albumin

    URINE albumin is measured by Medpace Laboratories

    Measured: once, approximately 30 years after delivery

  14. Urine Creatinine

    Urine creatinine is measured in urine by Medpace Laboratories.

    Measured: once, approximately 30 years after delivery

  15. Estimated Glomerular Filtration Rate (eGFR)

    eGFR (estimated glomerular filtration rate) is calculated based on serum creatinine value, age, and gender; measured by Medpace Laboratories.

    Measured: once, approximately 30 years after delivery

  16. High sensitivity C-reactive protein (hs CRP)

    hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.

    Measured: once, approximately 30 years after delivery

  17. Interleukin-6 (IL-6)

    IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.

    Measured: once, approximately 30 years after delivery

  18. 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.

    Measured: once, approximately 30 years after delivery

  19. Fibrinogen

    Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.

    Measured: once, approximately 30 years after delivery

  20. Resting blood pressure (diastolic)

    Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.

    Measured: once, approximately 30 years after delivery

  21. Resting blood pressure (systolic)

    Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.

    Measured: once, approximately 30 years after delivery

  22. 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.

    Measured: once, approximately 30 years after delivery

  23. 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

    Measured: once, approximately 30 years after delivery

  24. 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: measured once, approximately 30 years after delivery.

  25. 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: measured once, approximately 30 years after delivery.

Secondary outcomes (45)

  1. Medical diagnoses, signs, and symptoms

    Obtained via medical history interview by trained nurses.

    Measured: interview conducted approximately 30 years after delivery

  2. Current medications

    Obtained via medical history interview by trained nurses.

    Measured: interview conducted approximately 30 years after delivery

  3. 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.

    Measured: interview conducted approximately 30 years after delivery

  4. 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.

    Measured: interview conducted approximately 30 years after delivery

  5. 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.

    Measured: interview conducted approximately 30 years after delivery

  6. 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.

    Measured: interview conducted approximately 30 years after delivery

  7. 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.

    Measured: interview conducted approximately 30 years after delivery

  8. Number of pregnancies

    Self-reports of all pregnancies and dates

    Measured: interview conducted approximately 30 years after delivery

  9. Pregnancy losses

    self-reports of all pregnancies not resulting in a live birth

    Measured: interview conducted approximately 30 years after delivery

  10. Number of live births

    1. self-reports of all children's dates of births and 2) administrative data

    Measured: interview conducted approximately 30 years after delivery

  11. Pregnancy complications

    derived from administrative (birth certificate) data

    Measured: interview conducted approximately 30 years after delivery

  12. Birthweight

    determined through a combination of interview and administrative (birth certificate) data

    Measured: interview conducted approximately 30 years after delivery

  13. Gestational age

    determined through a combination of interview and administrative (birth certificate) data

    Measured: interview conducted approximately 30 years after delivery

  14. Menopause (age)

    Determined via interview

    Measured: interview conducted approximately 30 years after delivery

  15. Self-rated health

    Excellent, very good, good, fair, or poor

    Measured: interview conducted approximately 30 years after delivery

  16. 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.

    Measured: interview conducted approximately 30 years after delivery

  17. 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.

    Measured: interview conducted approximately 30 years after delivery

  18. Average daily fruit and vegetable intake

    derived from Diet NIH Eating at America's Table: All-Day Fruit \& vegetable Screener

    Measured: interview conducted approximately 30 years after delivery

  19. Percent energy from fat

    Derived from National Cancer Institute Percentage Energy from Fat Screener

    Measured: interview conducted approximately 30 years after delivery

  20. Dietary restraint/eating patterns

    Derived from Three Factor Eating Questionnaire: Measures three aspects of eating behaviors: cognitive restraint, uncontrolled eating, and emotional eating.

    Measured: interview conducted approximately 30 years after delivery

  21. Screening for Substance Use - TAPS 1 (tobacco, alcohol, prescription medication, and other substance use)

    use of substances in the past three months

    Measured: interview conducted approximately 30 years after delivery

  22. Substance Use Risk Level TAPS 2

    Risk category: no use in past 3 months, problem use, higher risk Substance Use Dependence

    Measured: interview conducted approximately 30 years after delivery

  23. Tobacco: Cigarettes

    Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day

    Measured: interview conducted approximately 30 years after delivery

  24. Tobacco: Cigars

    Ever smoked cigars, aged started and stopped, number of cigars per week

    Measured: interview conducted approximately 30 years after delivery

  25. Tobacco: Pipe, Hookah

    Ever smoke tobacco in pipe or hookah, age started and stopped, number of pipe bowls per week

    Measured: interview conducted approximately 30 years after delivery

  26. Tobacco: Smokeless Tobacco Snus

    Ever used Snus, age started and stopped, number of snus pouches per week

    Measured: interview conducted approximately 30 years after delivery

  27. Other Smokeless Tobacco (dip, chewing tobacco)

    : Ever used dip, chewing tobacco, age started and stopped, number of times per day

    Measured: interview conducted approximately 30 years after delivery

  28. Tobacco: Electronic Nicotine Products

    Ever used, age started and stopped, number of times per day

    Measured: interview conducted approximately 30 years after delivery

  29. 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.

    Measured: interview conducted approximately 30 years after delivery

  30. 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.

    Measured: interview conducted approximately 30 years after delivery

  31. 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.

    Measured: interview conducted approximately 30 years after delivery

  32. Duration of Marriage and partnered relationships

    List of current and previous married and partnered relationships, length of time together.

    Measured: interview conducted approximately 30 years after delivery

  33. Relationship Commitment: Current Relationship

    Structural commitment (dating, cohabitating, married)

    Measured: interview conducted approximately 30 years after delivery

  34. 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.

    Measured: interview conducted approximately 30 years after delivery

  35. Relationship Satisfaction: Current Relationship

    Overall happiness with relationship and satisfaction with partner: assessed with 2 questions regarding overall happiness and partner satisfaction.

    Measured: interview conducted approximately 30 years after delivery

  36. 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.

    Measured: interview conducted approximately 30 years after delivery

  37. 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

    Measured: interview conducted approximately 30 years after delivery

  38. Educational attainment (High School)

    High school education: graduated from high school, obtained General Education Development (GED), left high school without completing.

    Measured: interview conducted approximately 30 years after delivery

  39. Educational attainment (College)

    Highest Degree completed: Associates, Bachelors, Masters, PhD.

    Measured: interview conducted approximately 30 years after delivery

  40. Educational attainment (job training)

    Dates and types of job training programs

    Measured: interview conducted approximately 30 years after delivery

  41. Current work status (job)

    List of employment, duties, dates of employment

    Measured: interview conducted approximately 30 years after delivery

  42. Current work status (hours/week)

    number of hours work per week

    Measured: interview conducted approximately 30 years after delivery

  43. Arrests and Incarceration

    Dates and outcomes of arrests

    Measured: interview conducted approximately 30 years after delivery

  44. Arrests

    Types of arrests: misdemeanor, felony

    Measured: interview conducted approximately 30 years after delivery

  45. Arrests and incarceration

    number of days incarcerated

    Measured: interview conducted approximately 30 years after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2023
  2. Study start20 May 2020
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Longitudinal cohort study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,055 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06160037
Sponsor's protocol ID
20-0794
Status last verified
Jan 2026
First submitted
14 Nov 2023
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The investigators are only sharing IPD among the institutions involved in the conduct of this study.

Publications

  • 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.

    PubMed 29061565

  • 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.

    PubMed 28472021

  • 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.

    PubMed 26673558

  • 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.

    PubMed 26348752

  • 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.

    PubMed 26240271

  • 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.

    PubMed 28939713

  • 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.

    PubMed 29279935

  • 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.

    PubMed 17971557

  • 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.

    PubMed 27178804

  • 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.

    PubMed 22215892

  • 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.

    PubMed 29254928

  • 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.

    PubMed 25462912

  • 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.

    PubMed 24330084

  • Alexander BT, Dasinger JH, Intapad S. Fetal programming and cardiovascular pathology. Compr Physiol. 2015 Apr;5(2):997-1025. doi: 10.1002/cphy.c140036.

    PubMed 25880521

Questions about this trial

What is this clinical trial studying?

A study testing Transportation and Developmental Screening and Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy in people with Chronic Disease, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Height (standing) (time frame: Approximately 30 years after delivery). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06160037, which also lists 108 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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