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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,055
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-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.
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Height (standing)
Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece
Time frame: Approximately 30 years after delivery
Weight
weight measured in pounds
Time frame: Approximately 30 years after delivery
Waist circumference
waist circumference measured in cm, after exhaling, just above iliac crest, using a non-stretchable cloth measuring tape.
Time frame: once, approximately 30 years after delivery.
Hip circumference
hip circumference measured in cm, at point of greatest protrusion of gluteal muscles, using a non-stretchable cloth.
Time frame: once, approximately 30 years after delivery
Percent total body fat
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Time frame: once, approximately 30 years after delivery
% body fat in arms, legs
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Time frame: once, approximately 30 years after delivery
Visceral (trunk) fat
Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Time frame: once, approximately 30 years after delivery
Total Cholesterol (TC), High density lipoprotein (HDL), Low density lipoprotein (LDL)
TC, HDL, and LDL are measured by a clinical laboratory from serum samples by Medpace Laboratories.
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Time frame: once, approximately 30 years after delivery
Triglycerides
Measured by a clinical laboratory from serum samples by Medpace Laboratories
Time frame: once, approximately 30 years after delivery
Glycosylated hemoglobin
Measured by a clinical laboratory from whole blood samples by Medpace Laboratories
Time frame: once, approximately 30 years after delivery
Insulin-like growth factor 1 (IGF-1)
IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.
Time frame: once, approximately 30 years after delivery
Follicle-Stimulating Hormone (FSH)
FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.
Time frame: once, approximately 30 years after delivery
Urine-Albumin
URINE albumin is measured by Medpace Laboratories
Time frame: once, approximately 30 years after delivery
Urine Creatinine
Urine creatinine is measured in urine by Medpace Laboratories.
Time frame: once, approximately 30 years after delivery
Estimated Glomerular Filtration Rate (eGFR)
eGFR (estimated glomerular filtration rate) is calculated based on serum creatinine value, age, and gender; measured by Medpace Laboratories.
Time frame: once, approximately 30 years after delivery
High sensitivity C-reactive protein (hs CRP)
hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.
Time frame: once, approximately 30 years after delivery
Interleukin-6 (IL-6)
IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.
Time frame: once, approximately 30 years after delivery
Tumor Necrosis Factor alpha receptor 2
Tumor Necrosis Factor alpha receptor 2 (TNF alpha receptor 2) is measured in serum by Medpace Laboratories. This is an inflammatory marker.
Time frame: once, approximately 30 years after delivery
Fibrinogen
Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.
Time frame: once, approximately 30 years after delivery
Resting blood pressure (diastolic)
Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Time frame: once, approximately 30 years after delivery
Resting blood pressure (systolic)
Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Time frame: once, approximately 30 years after delivery
Carotid to femoral pulse wave velocity (cf-PWV)
Pulse wave velocity is a measure of arterial stiffness. It is a predictor of cardiovascular risk. It is measured using the SphygmoCor XCEL instrument.
Time frame: once, approximately 30 years after delivery
Augmentation index
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
Time frame: once, approximately 30 years after delivery
Mortality - Mothers
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.
Time frame: measured once, approximately 30 years after delivery.
Mortality - Offspring
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.
Time frame: measured once, approximately 30 years after delivery.
Medical diagnoses, signs, and symptoms
Obtained via medical history interview by trained nurses.
Time frame: interview conducted approximately 30 years after delivery
Current medications
Obtained via medical history interview by trained nurses.
Time frame: interview conducted approximately 30 years after delivery
Number of Hospitalizations per participant (mental/behavioral)
Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.
Time frame: interview conducted approximately 30 years after delivery
Number of Hospitalizations per participant (medical/surgical)
Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.
Time frame: interview conducted approximately 30 years after delivery
Disability (injury)
obtained from 1) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security Income.
Time frame: interview conducted approximately 30 years after delivery
Disability (physical)
1\) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security.
Time frame: interview conducted approximately 30 years after delivery
Disability (mental illness)
1\) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security Income.
Time frame: interview conducted approximately 30 years after delivery
Number of pregnancies
Self-reports of all pregnancies and dates
Time frame: interview conducted approximately 30 years after delivery
Pregnancy losses
self-reports of all pregnancies not resulting in a live birth
Time frame: interview conducted approximately 30 years after delivery
Number of live births
1\) self-reports of all children's dates of births and 2) administrative data
Time frame: interview conducted approximately 30 years after delivery
Pregnancy complications
derived from administrative (birth certificate) data
Time frame: interview conducted approximately 30 years after delivery
Birthweight
determined through a combination of interview and administrative (birth certificate) data
Time frame: interview conducted approximately 30 years after delivery
Gestational age
determined through a combination of interview and administrative (birth certificate) data
Time frame: interview conducted approximately 30 years after delivery
Menopause (age)
Determined via interview
Time frame: interview conducted approximately 30 years after delivery
Self-rated health
Excellent, very good, good, fair, or poor
Time frame: interview conducted approximately 30 years after delivery
Physical activity - Total Metabolic Equivalent of Task (MET) minutes per week
International Physical Activity Questionnaire (IPAQ): questionnaire to obtain internationally comparable data regarding physical activity. Questions ask about quantity and duration of physical activity.
Time frame: interview conducted approximately 30 years after delivery
Sleep Quality -- Global Score
Derived from Pittsburgh Sleep Quality Index (PSQI): questions on the PSQI are rated on a scale of 0-3, 0 = no difficulty to 3 = severe difficulty, and ask questions related to sleep latency, sleep duration, sleep disturbances, use of sleep medication,and daytime dysfunction.
Time frame: interview conducted approximately 30 years after delivery
Average daily fruit and vegetable intake
derived from Diet NIH Eating at America's Table: All-Day Fruit \& vegetable Screener
Time frame: interview conducted approximately 30 years after delivery
Percent energy from fat
Derived from National Cancer Institute Percentage Energy from Fat Screener
Time frame: interview conducted approximately 30 years after delivery
Dietary restraint/eating patterns
Derived from Three Factor Eating Questionnaire: Measures three aspects of eating behaviors: cognitive restraint, uncontrolled eating, and emotional eating.
Time frame: interview conducted approximately 30 years after delivery
Screening for Substance Use - TAPS 1 (tobacco, alcohol, prescription medication, and other substance use)
use of substances in the past three months
Time frame: interview conducted approximately 30 years after delivery
Substance Use Risk Level TAPS 2
Risk category: no use in past 3 months, problem use, higher risk Substance Use Dependence
Time frame: interview conducted approximately 30 years after delivery
Tobacco: Cigarettes
Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day
Time frame: interview conducted approximately 30 years after delivery
Tobacco: Cigars
Ever smoked cigars, aged started and stopped, number of cigars per week
Time frame: interview conducted approximately 30 years after delivery
Tobacco: Pipe, Hookah
Ever smoke tobacco in pipe or hookah, age started and stopped, number of pipe bowls per week
Time frame: interview conducted approximately 30 years after delivery
Tobacco: Smokeless Tobacco Snus
Ever used Snus, age started and stopped, number of snus pouches per week
Time frame: interview conducted approximately 30 years after delivery
Other Smokeless Tobacco (dip, chewing tobacco)
: Ever used dip, chewing tobacco, age started and stopped, number of times per day
Time frame: interview conducted approximately 30 years after delivery
Tobacco: Electronic Nicotine Products
Ever used, age started and stopped, number of times per day
Time frame: interview conducted approximately 30 years after delivery
Depression
Derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8a Adult: measures patient-reported outcomes like pain, fatigue, physical functioning, emotional distress, and social role participation.Each question uses a 5-point ordinal scale of "never," "rarely," sometimes," "often," and "always." Higher scores indicate higher depression severity.
Time frame: interview conducted approximately 30 years after delivery
Anxiety
Derived from the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 8a Adult. 7 Questions about feelings related to anxiety felt in the past seven days. Each question uses a 5-point ordinal scale of "never," "rarely," sometimes," "often," and "always." Higher scores indicate higher anxiety severity.
Time frame: interview conducted approximately 30 years after delivery
Mastery
Derived from Pearlin Mastery Scale. Measured on a 4 point Likert Scale, (1: Strongly Disagree, 4: Strongly agree). Scores can range from 7-28, with higher scores indicating a higher level of mastery.
Time frame: interview conducted approximately 30 years after delivery
Duration of Marriage and partnered relationships
List of current and previous married and partnered relationships, length of time together.
Time frame: interview conducted approximately 30 years after delivery
Relationship Commitment: Current Relationship
Structural commitment (dating, cohabitating, married)
Time frame: interview conducted approximately 30 years after delivery
Relationship Personal Commitment: Current Relationship
not at all committed to extremely committed relationship: 2 indicators of committment: structural and personal commitment. Personal commitment responses: 1-4, 1: not very committed, to 4: extremely committed.
Time frame: interview conducted approximately 30 years after delivery
Relationship Satisfaction: Current Relationship
Overall happiness with relationship and satisfaction with partner: assessed with 2 questions regarding overall happiness and partner satisfaction.
Time frame: interview conducted approximately 30 years after delivery
Partner Warmth Index: Current Relationship
Degree to which partner displayed warm behaviors: 3 questions regarding how often their partner displayed warm behaviors in the past month, ranging from 1-4. 1: never to 4: always.
Time frame: interview conducted approximately 30 years after delivery
Partner Hostility Index: Current Relationship
Degree to which partner displayed hostile behaviors: 5 questions asking about partner hostile behavior in past month, ranging from 1-4. 1: never, 4: always
Time frame: interview conducted approximately 30 years after delivery
Educational attainment (High School)
High school education: graduated from high school, obtained General Education Development (GED), left high school without completing.
Time frame: interview conducted approximately 30 years after delivery
Educational attainment (College)
Highest Degree completed: Associates, Bachelors, Masters, PhD.
Time frame: interview conducted approximately 30 years after delivery
Educational attainment (job training)
Dates and types of job training programs
Time frame: interview conducted approximately 30 years after delivery
Current work status (job)
List of employment, duties, dates of employment
Time frame: interview conducted approximately 30 years after delivery
Current work status (hours/week)
number of hours work per week
Time frame: interview conducted approximately 30 years after delivery
Arrests and Incarceration
Dates and outcomes of arrests
Time frame: interview conducted approximately 30 years after delivery
Arrests
Types of arrests: misdemeanor, felony
Time frame: interview conducted approximately 30 years after delivery
Arrests and incarceration
number of days incarcerated
Time frame: interview conducted approximately 30 years after delivery