Chronic Disease
Conditions
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.
Interventions
BEHAVIORALTransportation and Developmental Screening
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.
BEHAVIORALTransportation, Screening, and Nurse-Visitation during Pregnancy and Infancy
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.
Sponsors
University of Colorado, Denver
University of Rochester
Medpace, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Those involved in conducting assessments of study participants have been masked to treatment assignment for the 30-year period following study enrollment during pregnancy.
Intervention model description
Longitudinal cohort study
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight | Approximately 30 years after delivery | weight measured in pounds |
| 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 |
| Visceral (trunk) fat | 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 |
| 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. |
| 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. |
| Interleukin-6 (IL-6) | 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 | 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 | once, approximately 30 years after delivery | Fibrinogen is measured in plasma 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. |
| Resting blood pressure (systolic) | 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) | 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 | 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 - Mothers | 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. |
| Mortality - Offspring | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medical diagnoses, signs, and symptoms | interview conducted approximately 30 years after delivery | Obtained via medical history interview by trained nurses. |
| Current medications | interview conducted approximately 30 years after delivery | Obtained via medical history interview by trained nurses. |
| 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. |
| 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. |
| 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. |
| Number of pregnancies | interview conducted approximately 30 years after delivery | Self-reports of all pregnancies and dates |
| Pregnancy losses | interview conducted approximately 30 years after delivery | self-reports of all pregnancies not resulting in a live birth |
| 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 |
| Pregnancy complications | interview conducted approximately 30 years after delivery | derived from administrative (birth certificate) data |
| Birthweight | interview conducted approximately 30 years after delivery | determined through a combination of interview and administrative (birth certificate) data |
| Gestational age | 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 |
| 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. |
| 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 |
| Percent energy from fat | interview conducted approximately 30 years after delivery | Derived from National Cancer Institute Percentage Energy from Fat Screener |
| 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 |
| 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: Cigarettes | interview conducted approximately 30 years after delivery | Ever smoked cigarettes, age started and stopped smoking, number of cigarettes per day |
| Tobacco: Cigars | interview conducted approximately 30 years after delivery | Ever smoked cigars, aged started and stopped, number of cigars per week |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| Educational attainment (job training) | interview conducted approximately 30 years after delivery | Dates and types of job training programs |
| 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 |
| Arrests and Incarceration | interview conducted approximately 30 years after delivery | Dates and outcomes of arrests |
| Arrests | interview conducted approximately 30 years after delivery | Types of arrests: misdemeanor, felony |
| Arrests and incarceration | interview conducted approximately 30 years after delivery | number of days incarcerated |
Countries
United States
Outcome results
None listed