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

Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece

weight measured in pounds

waist circumference measured in cm, after exhaling, just above iliac crest, using a non-stretchable cloth measuring tape.

hip circumference measured in cm, at point of greatest protrusion of gluteal muscles, using a non-stretchable cloth.

Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer

TC, HDL, and LDL are measured by a clinical laboratory from serum samples by Medpace Laboratories.

Measured by a clinical laboratory from serum samples by Medpace Laboratories

Measured by a clinical laboratory from whole blood samples by Medpace Laboratories

IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.

FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.

URINE albumin is measured by Medpace Laboratories

Urine creatinine is measured in urine by Medpace Laboratories.

eGFR (estimated glomerular filtration rate) is calculated based on serum creatinine value, age, and gender; measured by Medpace Laboratories.

hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.

IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.

Tumor Necrosis Factor alpha receptor 2 (TNF alpha receptor 2) is measured in serum by Medpace Laboratories. This is an inflammatory marker.

Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.

Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.

Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.

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 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

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.

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.

Obtained via medical history interview by trained nurses.

Obtained via medical history interview by trained nurses.

Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.

Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.

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.

• administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security.

• administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security Income.

Self-reports of all pregnancies and dates

self-reports of all pregnancies not resulting in a live birth

• self-reports of all children's dates of births and 2) administrative data

derived from administrative (birth certificate) data

determined through a combination of interview and administrative (birth certificate) data

determined through a combination of interview and administrative (birth certificate) data

Determined via interview

Excellent, very good, good, fair, or poor

International Physical Activity Questionnaire (IPAQ): questionnaire to obtain internationally comparable data regarding physical activity. Questions ask about quantity and duration of physical activity.

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.

derived from Diet NIH Eating at America's Table: All-Day Fruit & vegetable Screener

Derived from National Cancer Institute Percentage Energy from Fat Screener

Derived from Three Factor Eating Questionnaire: Measures three aspects of eating behaviors: cognitive restraint, uncontrolled eating, and emotional eating.

use of substances in the past three months

Risk category: no use in past 3 months, problem use, higher risk Substance Use Dependence

Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day

Ever smoked cigars, aged started and stopped, number of cigars per week

Ever smoke tobacco in pipe or hookah, age started and stopped, number of pipe bowls per week

Ever used Snus, age started and stopped, number of snus pouches per week

: Ever used dip, chewing tobacco, age started and stopped, number of times per day

Ever used, age started and stopped, number of times per day

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.

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.

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.

List of current and previous married and partnered relationships, length of time together.

Structural commitment (dating, cohabitating, married)

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.

Overall happiness with relationship and satisfaction with partner: assessed with 2 questions regarding overall happiness and partner satisfaction.

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.

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

High school education: graduated from high school, obtained General Education Development (GED), left high school without completing.

Highest Degree completed: Associates, Bachelors, Masters, PhD.

Dates and types of job training programs

List of employment, duties, dates of employment

number of hours work per week

Dates and outcomes of arrests

Types of arrests: misdemeanor, felony

number of days incarcerated