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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease: 29-year Follow-Up of a Randomized Clinical Trial

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: Transportation and Developmental Screening
* Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Longitudinal cohort study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1. Transportation and Screening<br>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. | Behavioral: Transportation and Developmental Screening<br>* 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.<br>|
| Experimental: Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy<br>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. | Behavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Height (standing) | Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece | Approximately 30 years after delivery | 
| Weight | weight measured in pounds | 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. | 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. | once, approximately 30 years after delivery | 
| Percent total body fat | Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer | once, approximately 30 years after delivery | 
| % body fat in arms, legs | Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer | once, approximately 30 years after delivery | 
| Visceral (trunk) fat | Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer | 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. | once, approximately 30 years after delivery | 
| Triglycerides | Measured by a clinical laboratory from serum samples by Medpace Laboratories | once, approximately 30 years after delivery | 
| Glycosylated hemoglobin | Measured by a clinical laboratory from whole blood samples by Medpace Laboratories | 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. | 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. | once, approximately 30 years after delivery | 
| Urine-Albumin | URINE albumin is measured by Medpace Laboratories | once, approximately 30 years after delivery | 
| Urine Creatinine | Urine creatinine is measured in urine by Medpace Laboratories. | 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. | 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. | once, approximately 30 years after delivery | 
| Interleukin-6 (IL-6) | IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker. | 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. | once, approximately 30 years after delivery | 
| Fibrinogen | Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker. | once, approximately 30 years after delivery | 
| Resting blood pressure (diastolic) | Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly. | once, approximately 30 years after delivery | 
| Resting blood pressure (systolic) | Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly. | 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. | 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 | once, approximately 30 years after delivery | 
| Mortality - Cause | In the original NHLBI proposal the investigators had not differentiated natural versus preventable/external causes of death. Given COVID-19, the investigaors have refined the hypotheses: 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. Among offspring, however, those who become infected with COVID are less likely to die given that their underlying chronic conditions are less likely to consist of serious chronic conditions. Therefore, we expect the treatment-control differences to be limited to preventable/external causes as operationalized in a recent publication: https://pubmed.ncbi.nlm.nih.gov/34420828/ | measured once, approximately 30 years after delivery. | 
| Morality - Date | Based on data gathered from national death index (NDI). In the original NHLBI proposal the investigators had not differentiated natural versus preventable/external causes of death. Given COVID-19, the investigators have refined the hypotheses: 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. Among offspring, however, those who become infected with COVID are less likely to die given that their underlying chronic conditions are less likely to consist of serious chronic conditions. Therefore, the investigators expect the treatment-control differences to be limited to preventable/external causes as operationalized in a recent publication: https://pubmed.ncbi.nlm.nih.gov/34420828/ | measured once, approximately 30 years after delivery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical diagnoses, signs, and symptoms | Obtained via medical history interview by trained nurses. | interview conducted approximately 30 years after delivery | 
| Current medications | Obtained via medical history interview by trained nurses. | 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. | 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. | 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. | 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. | 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. | interview conducted approximately 30 years after delivery | 
| Number of pregnancies | Self-reports of all pregnancies and dates | interview conducted approximately 30 years after delivery | 
| Pregnancy losses | self-reports of all pregnancies not resulting in a live birth | 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 | interview conducted approximately 30 years after delivery | 
| Pregnancy complications | derived from administrative (birth certificate) data | interview conducted approximately 30 years after delivery | 
| Birthweight | determined through a combination of interview and administrative (birth certificate) data | interview conducted approximately 30 years after delivery | 
| Gestational age | determined through a combination of interview and administrative (birth certificate) data | interview conducted approximately 30 years after delivery | 
| Menopause (age) | Determined via interview | interview conducted approximately 30 years after delivery | 
| Self-rated health | Excellent, very good, good, fair, or poor | 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. | 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. | 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 | interview conducted approximately 30 years after delivery | 
| Percent energy from fat | Derived from National Cancer Institute Percentage Energy from Fat Screener | 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. | 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 | 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 | interview conducted approximately 30 years after delivery | 
| Tobacco: Cigarettes | Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day | interview conducted approximately 30 years after delivery | 
| Tobacco: Cigars | Ever smoked cigars, aged started and stopped, number of cigars per week | 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 | interview conducted approximately 30 years after delivery | 
| Tobacco: Smokeless Tobacco Snus | Ever used Snus, age started and stopped, number of snus pouches per week | 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 | interview conducted approximately 30 years after delivery | 
| Tobacco: Electronic Nicotine Products | Ever used, age started and stopped, number of times per day | 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. | 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. | 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. | 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. | interview conducted approximately 30 years after delivery | 
| Relationship Commitment: Current Relationship | Structural commitment (dating, cohabitating, married) | 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. | 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. | 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. | 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 | 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. | interview conducted approximately 30 years after delivery | 
| Educational attainment (College) | Highest Degree completed: Associates, Bachelors, Masters, PhD. | interview conducted approximately 30 years after delivery | 
| Educational attainment (job training) | Dates and types of job training programs | interview conducted approximately 30 years after delivery | 
| Current work status (job) | List of employment, duties, dates of employment | interview conducted approximately 30 years after delivery | 
| Current work status (hours/week) | number of hours work per week | interview conducted approximately 30 years after delivery | 
| Arrests and Incarceration | Dates and outcomes of arrests | interview conducted approximately 30 years after delivery | 
| Arrests | Types of arrests: misdemeanor, felony | interview conducted approximately 30 years after delivery | 
| Arrests and incarceration | number of days incarcerated | interview conducted approximately 30 years after delivery |