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

NCT06160037 | Completed

• 1 other identifier: 20-0794
• Study Type: interventional
• Target: 1,055
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (45)

• Medical diagnoses, signs, and symptoms

  interview conducted approximately 30 years after delivery

• Current medications

  interview conducted approximately 30 years after delivery

• Number of Hospitalizations per participant (mental/behavioral)

  interview conducted approximately 30 years after delivery

• Number of Hospitalizations per participant (medical/surgical)

  interview conducted approximately 30 years after delivery

• Disability (injury)

  interview conducted approximately 30 years after delivery

Study Arms (2)

Arm 1. Transportation and Screening

ACTIVE COMPARATOR

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 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy

EXPERIMENTAL

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

Interventions

Transportation and Developmental Screening BEHAVIORAL

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.

Arm 1. Transportation and Screening

Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy BEHAVIORAL

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.

Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: collaborator
• Medpace, Inc.: collaborator
• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (108)

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MeSH Terms

Conditions

Chronic Disease

Interventions

Transportation; Mass Screening

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those involved in conducting assessments of study participants have been masked to treatment assignment for the 30-year period following study enrollment during pregnancy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal cohort study

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 7, 2023
• Study Start: May 20, 2020
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: March 1, 2025
• Access Criteria: check with Nancy about this

Locations

US (1)