Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease: 29-year Follow-Up of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,055
- 试验地点
- 2
- 主要终点
- Mortality - Mothers
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Those involved in conducting assessments of study participants have been masked to treatment assignment for the 30-year period following study enrollment during pregnancy.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mortality - Mothers
时间窗: measured once, approximately 30 years after delivery.
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.
Height (standing)
时间窗: Approximately 30 years after delivery
Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece
Weight
时间窗: Approximately 30 years after delivery
weight measured in pounds
Waist circumference
时间窗: once, approximately 30 years after delivery.
waist circumference measured in cm, after exhaling, just above iliac crest, using a non-stretchable cloth measuring tape.
Hip circumference
时间窗: once, approximately 30 years after delivery
hip circumference measured in cm, at point of greatest protrusion of gluteal muscles, using a non-stretchable cloth.
Percent total body fat
时间窗: once, approximately 30 years after delivery
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
% body fat in arms, legs
时间窗: once, approximately 30 years after delivery
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Visceral (trunk) fat
时间窗: once, approximately 30 years after delivery
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Total Cholesterol (TC), High density lipoprotein (HDL), Low density lipoprotein (LDL)
时间窗: once, approximately 30 years after delivery
TC, HDL, and LDL are measured by a clinical laboratory from serum samples by Medpace Laboratories.
Triglycerides
时间窗: once, approximately 30 years after delivery
Measured by a clinical laboratory from serum samples by Medpace Laboratories
Glycosylated hemoglobin
时间窗: once, approximately 30 years after delivery
Measured by a clinical laboratory from whole blood samples by Medpace Laboratories
Insulin-like growth factor 1 (IGF-1)
时间窗: once, approximately 30 years after delivery
IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.
Follicle-Stimulating Hormone (FSH)
时间窗: once, approximately 30 years after delivery
FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.
Urine-Albumin
时间窗: once, approximately 30 years after delivery
URINE albumin is measured by Medpace Laboratories
Urine Creatinine
时间窗: once, approximately 30 years after delivery
Urine creatinine is measured in urine by Medpace Laboratories.
Estimated Glomerular Filtration Rate (eGFR)
时间窗: once, approximately 30 years after delivery
eGFR (estimated glomerular filtration rate) is calculated based on serum creatinine value, age, and gender; measured by Medpace Laboratories.
High sensitivity C-reactive protein (hs CRP)
时间窗: once, approximately 30 years after delivery
hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.
Interleukin-6 (IL-6)
时间窗: once, approximately 30 years after delivery
IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.
Tumor Necrosis Factor alpha receptor 2
时间窗: once, approximately 30 years after delivery
Tumor Necrosis Factor alpha receptor 2 (TNF alpha receptor 2) is measured in serum by Medpace Laboratories. This is an inflammatory marker.
Fibrinogen
时间窗: once, approximately 30 years after delivery
Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.
Resting blood pressure (diastolic)
时间窗: once, approximately 30 years after delivery
Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Resting blood pressure (systolic)
时间窗: once, approximately 30 years after delivery
Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Carotid to femoral pulse wave velocity (cf-PWV)
时间窗: once, approximately 30 years after delivery
Pulse wave velocity is a measure of arterial stiffness. It is a predictor of cardiovascular risk. It is measured using the SphygmoCor XCEL instrument.
Augmentation index
时间窗: once, approximately 30 years after delivery
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
Mortality - Offspring
时间窗: measured once, approximately 30 years after delivery.
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.
次要结局
- Number of live births(interview conducted approximately 30 years after delivery)
- Arrests(interview conducted approximately 30 years after delivery)
- Medical diagnoses, signs, and symptoms(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)
- Disability (physical)(interview conducted approximately 30 years after delivery)
- Number of pregnancies(interview conducted approximately 30 years after delivery)
- Number of Hospitalizations per participant (mental/behavioral)(interview conducted approximately 30 years after delivery)
- Disability (mental illness)(interview conducted approximately 30 years after delivery)
- Gestational age(interview conducted approximately 30 years after delivery)
- Current work status (job)(interview conducted approximately 30 years after delivery)
- Current work status (hours/week)(interview conducted approximately 30 years after delivery)
- Current medications(interview conducted approximately 30 years after delivery)
- Self-rated health(interview conducted approximately 30 years after delivery)
- Physical activity - Total Metabolic Equivalent of Task (MET) minutes per week(interview conducted approximately 30 years after delivery)
- Sleep Quality -- Global Score(interview conducted approximately 30 years after delivery)
- Dietary restraint/eating patterns(interview conducted approximately 30 years after delivery)
- Screening for Substance Use - TAPS 1 (tobacco, alcohol, prescription medication, and other substance use)(interview conducted approximately 30 years after delivery)
- Tobacco: Cigarettes(interview conducted approximately 30 years after delivery)
- Pregnancy losses(interview conducted approximately 30 years after delivery)
- Pregnancy complications(interview conducted approximately 30 years after delivery)
- Percent energy from fat(interview conducted approximately 30 years after delivery)
- Relationship Commitment: Current Relationship(interview conducted approximately 30 years after delivery)
- Relationship Personal Commitment: Current Relationship(interview conducted approximately 30 years after delivery)
- Partner Hostility Index: Current Relationship(interview conducted approximately 30 years after delivery)
- Birthweight(interview conducted approximately 30 years after delivery)
- Menopause (age)(interview conducted approximately 30 years after delivery)
- Average daily fruit and vegetable intake(interview conducted approximately 30 years after delivery)
- Tobacco: Pipe, Hookah(interview conducted approximately 30 years after delivery)
- Tobacco: Smokeless Tobacco Snus(interview conducted approximately 30 years after delivery)
- Other Smokeless Tobacco (dip, chewing tobacco)(interview conducted approximately 30 years after delivery)
- Tobacco: Electronic Nicotine Products(interview conducted approximately 30 years after delivery)
- Duration of Marriage and partnered relationships(interview conducted approximately 30 years after delivery)
- Relationship Satisfaction: Current Relationship(interview conducted approximately 30 years after delivery)
- Educational attainment (job training)(interview conducted approximately 30 years after delivery)
- Arrests and Incarceration(interview conducted approximately 30 years after delivery)
- Substance Use Risk Level TAPS 2(interview conducted approximately 30 years after delivery)
- Tobacco: Cigars(interview conducted approximately 30 years after delivery)
- Anxiety(interview conducted approximately 30 years after delivery)
- Depression(interview conducted approximately 30 years after delivery)
- Mastery(interview conducted approximately 30 years after delivery)
- Partner Warmth Index: Current Relationship(interview conducted approximately 30 years after delivery)
- Educational attainment (High School)(interview conducted approximately 30 years after delivery)
- Educational attainment (College)(interview conducted approximately 30 years after delivery)
- Arrests and incarceration(interview conducted approximately 30 years after delivery)