Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease
NCT ID: NCT06160037
Last Updated: 2026-01-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
1055 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-05-20
Study Completion Date
2024-05-31
Brief Summary
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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.
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Detailed Description
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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.
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
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Chronic Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Longitudinal cohort study
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Outcome Assessors
Those involved in conducting assessments of study participants have been masked to treatment assignment for the 30-year period following study enrollment during pregnancy.
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Transportation and Developmental Screening
Intervention Type
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 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.
Group Type
EXPERIMENTAL
Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
Intervention Type
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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.
* Women \> 29 weeks pregnant
* Previous live births
* Possessing chronic illnesses like hypertensive disorders requiring medical treatment, severe cardiac disease, large uterine fibroids.
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Rochester
OTHER
Sponsor Role
collaborator
Medpace, Inc.
INDUSTRY
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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20-0794
Identifier Type: -
Identifier Source: org_study_id
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