Clinical trial

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

Active, not recruiting · Not applicable · 0 countries · Registry ID NCT02820402

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age0 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionPediatric Obesity

Full registry criteria

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

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

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)Research measurements at birth, 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).

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.

Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weightBefore the Project Viva pregnancy and 1-year postpartum

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.

Child metabolic risk score, calculated as a standard deviation (SD) scoreHDL-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.

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).

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 diseaseInterviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).

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… 1. Asthma? 2. 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.

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.