Influence of Prenatal and Early Childhood Home-Visiting by Nurses on Development of Chronic Disease
- Conditions
- Chronic Disease
- Interventions
- Behavioral: Transportation and Developmental ScreeningBehavioral: Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
- Registration Number
- NCT06160037
- Lead Sponsor
- University of Colorado, Denver
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 742
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1. Transportation and Screening Transportation and Developmental Screening 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. Arm 2. Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy Transportation, Screening, and Nurse-Visitation during Pregnancy and Infancy 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.
- Primary Outcome Measures
Name Time Method Visceral (trunk) fat once, approximately 30 years after delivery Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
Height (standing) Approximately 30 years after delivery Description: height measured in cm while participant is standing in bare feet using a stationary stadiometer with headpiece
Waist circumference 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 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 once, approximately 30 years after delivery Measured using the Tanita-780U Multifrequency Segmental Body Composition Analyzer
% body fat in arms, legs 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) once, approximately 30 years after delivery TC, HDL, and LDL are measured by a clinical laboratory from serum samples by Medpace Laboratories.
Triglycerides once, approximately 30 years after delivery Measured by a clinical laboratory from serum samples by Medpace Laboratories
Glycosylated hemoglobin once, approximately 30 years after delivery Measured by a clinical laboratory from whole blood samples by Medpace Laboratories
Fibrinogen once, approximately 30 years after delivery Fibrinogen is measured in plasma by Medpace Laboratories. This is an inflammatory marker.
Urine-Albumin once, approximately 30 years after delivery URINE albumin is measured by Medpace Laboratories
Urine Creatinine once, approximately 30 years after delivery Urine creatinine is measured in urine by Medpace Laboratories.
Estimated Glomerular Filtration Rate (eGFR) 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) once, approximately 30 years after delivery hs-CRP measured in plasma by Medpace Laboratories . This is an inflammatory marker.
Tumor Necrosis Factor alpha receptor 2 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.
Resting blood pressure (diastolic) once, approximately 30 years after delivery Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Augmentation index 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 - Cause measured once, approximately 30 years after delivery. 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/
Insulin-like growth factor 1 (IGF-1) once, approximately 30 years after delivery IGF-1 is a hormonal mediator and is analyzed in serum by Medpace Laboratories.
Follicle-Stimulating Hormone (FSH) once, approximately 30 years after delivery FSH is an indicator of menopausal status and is measured in serum by the Medpace Laboratories.
Interleukin-6 (IL-6) once, approximately 30 years after delivery IL-6 measured in serum by Medpace laboratory. This is an inflammatory marker.
Carotid to femoral pulse wave velocity (cf-PWV) 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.
Resting blood pressure (systolic) once, approximately 30 years after delivery Blood pressure read measured through SphygmoCor XCEL, taken after 10 minutes of sitting quietly.
Morality - Date measured once, approximately 30 years after delivery. 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/
Weight Approximately 30 years after delivery weight measured in pounds
- Secondary Outcome Measures
Name Time Method Number of live births interview conducted approximately 30 years after delivery 1) self-reports of all children's dates of births and 2) administrative data
Arrests interview conducted approximately 30 years after delivery Types of arrests: misdemeanor, felony
Medical diagnoses, signs, and symptoms interview conducted approximately 30 years after delivery Obtained via medical history interview by trained nurses.
Number of Hospitalizations per participant (medical/surgical) interview conducted approximately 30 years after delivery Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.
Disability (injury) interview conducted approximately 30 years after delivery 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.
Disability (physical) interview conducted approximately 30 years after delivery 1) administrative data on Social Security disability payment and 2) information derived from the interview regarding if and why participant is receiving Supplemental Security.
Number of pregnancies interview conducted approximately 30 years after delivery Self-reports of all pregnancies and dates
Number of Hospitalizations per participant (mental/behavioral) interview conducted approximately 30 years after delivery Obtained via medical history interview by trained nurses, and by matching administrative hospitalization records (in Tennessee only) to study subjects who have given consent.
Disability (mental illness) interview conducted approximately 30 years after delivery 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.
Gestational age interview conducted approximately 30 years after delivery determined through a combination of interview and administrative (birth certificate) data
Current work status (job) interview conducted approximately 30 years after delivery List of employment, duties, dates of employment
Current work status (hours/week) interview conducted approximately 30 years after delivery number of hours work per week
Current medications interview conducted approximately 30 years after delivery Obtained via medical history interview by trained nurses.
Self-rated health interview conducted approximately 30 years after delivery Excellent, very good, good, fair, or poor
Physical activity - Total Metabolic Equivalent of Task (MET) minutes per week interview conducted approximately 30 years after delivery International Physical Activity Questionnaire (IPAQ): questionnaire to obtain internationally comparable data regarding physical activity. Questions ask about quantity and duration of physical activity.
Sleep Quality -- Global Score interview conducted approximately 30 years after delivery 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.
Dietary restraint/eating patterns interview conducted approximately 30 years after delivery Derived from Three Factor Eating Questionnaire: Measures three aspects of eating behaviors: cognitive restraint, uncontrolled eating, and emotional eating.
Screening for Substance Use - TAPS 1 (tobacco, alcohol, prescription medication, and other substance use) interview conducted approximately 30 years after delivery use of substances in the past three months
Tobacco: Cigarettes interview conducted approximately 30 years after delivery Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day
Pregnancy losses interview conducted approximately 30 years after delivery self-reports of all pregnancies not resulting in a live birth
Pregnancy complications interview conducted approximately 30 years after delivery derived from administrative (birth certificate) data
Percent energy from fat interview conducted approximately 30 years after delivery Derived from National Cancer Institute Percentage Energy from Fat Screener
Relationship Commitment: Current Relationship interview conducted approximately 30 years after delivery Structural commitment (dating, cohabitating, married)
Relationship Personal Commitment: Current Relationship interview conducted approximately 30 years after delivery 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.
Partner Hostility Index: Current Relationship interview conducted approximately 30 years after delivery 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
Birthweight interview conducted approximately 30 years after delivery determined through a combination of interview and administrative (birth certificate) data
Menopause (age) interview conducted approximately 30 years after delivery Determined via interview
Average daily fruit and vegetable intake interview conducted approximately 30 years after delivery derived from Diet NIH Eating at America's Table: All-Day Fruit \& vegetable Screener
Tobacco: Pipe, Hookah interview conducted approximately 30 years after delivery Ever smoke tobacco in pipe or hookah, age started and stopped, number of pipe bowls per week
Tobacco: Smokeless Tobacco Snus interview conducted approximately 30 years after delivery Ever used Snus, age started and stopped, number of snus pouches per week
Other Smokeless Tobacco (dip, chewing tobacco) interview conducted approximately 30 years after delivery : Ever used dip, chewing tobacco, age started and stopped, number of times per day
Tobacco: Electronic Nicotine Products interview conducted approximately 30 years after delivery Ever used, age started and stopped, number of times per day
Duration of Marriage and partnered relationships interview conducted approximately 30 years after delivery List of current and previous married and partnered relationships, length of time together.
Relationship Satisfaction: Current Relationship interview conducted approximately 30 years after delivery Overall happiness with relationship and satisfaction with partner: assessed with 2 questions regarding overall happiness and partner satisfaction.
Educational attainment (job training) interview conducted approximately 30 years after delivery Dates and types of job training programs
Arrests and Incarceration interview conducted approximately 30 years after delivery Dates and outcomes of arrests
Substance Use Risk Level TAPS 2 interview conducted approximately 30 years after delivery Risk category: no use in past 3 months, problem use, higher risk Substance Use Dependence
Tobacco: Cigars interview conducted approximately 30 years after delivery Ever smoked cigars, aged started and stopped, number of cigars per week
Anxiety interview conducted approximately 30 years after delivery 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.
Depression interview conducted approximately 30 years after delivery 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.
Mastery interview conducted approximately 30 years after delivery 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.
Partner Warmth Index: Current Relationship interview conducted approximately 30 years after delivery 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.
Educational attainment (High School) interview conducted approximately 30 years after delivery High school education: graduated from high school, obtained General Education Development (GED), left high school without completing.
Educational attainment (College) interview conducted approximately 30 years after delivery Highest Degree completed: Associates, Bachelors, Masters, PhD.
Arrests and incarceration interview conducted approximately 30 years after delivery number of days incarcerated
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States