Clinical Trials Directory

Trials / Completed

CompletedNCT06160037

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
1,055 (actual)
Sponsor
University of Colorado, Denver · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALTransportation and Developmental ScreeningArm 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.
BEHAVIORALTransportation, Screening, and Nurse-Visitation during Pregnancy and InfancyArm 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.

Timeline

Start date
2020-05-20
Primary completion
2024-05-31
Completion
2024-05-31
First posted
2023-12-07
Last updated
2026-01-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06160037. Inclusion in this directory is not an endorsement.