Project Viva: a Longitudinal Study of Health for the Next Generation

Study Overview
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Brief Summary
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Project Viva is a prospective cohort study of maternal and child health, following over 2,000 mother-child pairs from the mother's pregnancy into the child's adolescence.

Detailed Description
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In 1999-2002 the Project Viva team recruited 2,670 pregnant women during their first trimester of pregnancy from eight obstetric (OB) offices of a multi-site group practice in eastern Massachusetts. 2,128 of the women had a live birth and approximately 1,600 mother-child pairs are still involved in the study. Project Viva collects data annually from multiple sources, including questionnaires, interviews, medical records, examinations, and biospecimen samples. Project Viva intends to follow participants as long as there is grant funding and interest from the participants. Some of the most beneficial health findings come from long-term follow-up.

Official Title
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Project Viva: a Longitudinal Study of Health for the Next Generation

Conditions
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Pediatric Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than 22 weeks pregnant at the time of enrollment Receive prenatal care at one of the selected practices Plan on delivering at one of two study hospitals Be able to answer questionnaires in English. Exclusion Criteria: Multiple gestation Plans to move away before delivery Plans to terminate the pregnancy

Ages Eligible for Study
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Minimum Age: 0 Years

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cross-sectional and longitudinal measurements of child BMI z-score in kg/m^2, standardized into a sex- and age-specific z-score using national reference data (CDC growth charts) | The study team measures child weight and length/height at each time point, and BMI is calculated and standardized based on the child's age at the time of measurement. | Research measurements at birth, 6mo, early childhood ( 3y), mid-childhood ( 8y), early teen ( 14y), and mid-late teen ( 17y). | 
| Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight | Investigators obtained prenatal weights from the clinical record, and calculated total gestational weight gain (GWG) as the difference between the last weight recorded in the 4 weeks prior to delivery and pre-pregnancy weight. Project Viva mothers reported their weight at 1-year postpartum via questionnaire. | Before the Project Viva pregnancy and 1-year postpartum | 
| Child metabolic risk score, calculated as a standard deviation (SD) score | Investigators derived the metabolic risk score as the mean of 5 sex- and cohort-specific z-scores for: waist circumference (cm), systolic blood pressure (SBP, calculated as the average of 5 measurements taken 1 minute apart), HDL cholesterol (mg/dL, scaled inversely), log-transformed triglycerides (mg/dL) and log-transformed HOMA-IR (calculated as fasting insulin [μU/mL] x fasting glucose [mg/dL]/405). | HDL-cholesterol, triglycerides, insulin, glucose and waist circumference measured at  8y,  14y, and  17y of age. Blood pressure measured at birth,  6mo,  3y,  8y,  14y, and  17y. Metabolic risk score calculated at  8y,  14y, and  17y. | 
| Child neurodevelopment, assessed by continuous scores on the Wide Range Assessment of Memory and Learning, Second Edition (WRAML2), Design and Picture Memory subtests and The Kaufman Brief Intelligence Test, Second Edition (KBIT-2) |  | Children completed both the WRAML2 and the KBIT-2 at the mid-childhood visit ( 8y) | 
| Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease | Mothers answered yes or no when asked have you ever been told by a health care professional, such as a doctor, physician assistant or nurse practitioner, that your child has… Asthma? Wheezing or reactive airways? Mothers reported asthma, wheezing and reactive airways as a single outcome at the infancy visit and separately at the early and mid-childhood visits. At the early teen visit, the mother reported a diagnosis of asthma only. | Interviews administered at 6mo, early childhood ( 3y), mid-childhood ( 8y), early teen ( 14y), and mid-late teen ( 17y). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child's birth length in cm |  | Measured at birth | 
| Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data |  | Measured at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Obesity, Diet, Maternal/child health, Asthma/allergy, Air pollution, Epigenetics, Cognition/behavior