Viewing Study NCT06160037



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Last Modification Date: 2024-10-26 @ 3:15 PM
Study NCT ID: NCT06160037
Status: RECRUITING
Last Update Posted: 2023-12-07
First Post: 2023-11-14

Brief Title: Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease
Sponsor: University of Colorado Denver
Organization: University of Colorado Denver

Study Overview

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
Status: RECRUITING
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
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 infanttoddler 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None