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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Chronic Disease

Treatments: Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy; Behavioral: Transportation and Developmental Screening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06160037

20-0794

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,055 patients

Sex: All

Volunteers: No Healthy Volunteers

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

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,055 participants in 2 patient groups

Arm 1. Transportation and Screening

Active Comparator group

Description:

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.

Treatment:

Behavioral: Transportation and Developmental Screening

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

Experimental group

Description:

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.

Treatment:

Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy