Project Viva: a Longitudinal Study of Health for the Next Generation
- Conditions
- Pediatric Obesity
- Registration Number
- NCT02820402
- Lead Sponsor
- Harvard Pilgrim Health Care
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2128
- 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.
- Multiple gestation
- Plans to move away before delivery
- Plans to terminate the pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease Interviews 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.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.
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) Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight Before 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) score 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. 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).
- Secondary Outcome Measures
Name Time Method Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data Measured at birth Child's birth length in cm Measured at birth