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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02820402
Enrollment
2128
Registered
2016-07-01
Start date
1999-01-01
Completion date
2028-04-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

Pregnancy, Obesity, Diet, Maternal/child health, Asthma/allergy, Air pollution, Epigenetics, Cognition/behavior

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.

Interventions

None listed

Sponsors

Harvard Pilgrim Health Care
Lead SponsorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Harvard School of Public Health (HSPH)
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 postpartumInvestigators 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.

Secondary

MeasureTime frame
Child's birth length in cmMeasured at birth
Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference dataMeasured at birth

Contacts

PRINCIPAL_INVESTIGATOREmily Oken, MD, MPH

Harvard Medical School / Harvard Pilgrim Health Care Institute

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026