This trial is active, not recruiting.

Condition pediatric obesity
Sponsor Harvard Pilgrim Health Care
Collaborator Brigham and Women's Hospital
Start date January 1999
End date December 2021
Trial size 2128 participants
Trial identifier NCT02820402, 5R37HD034568


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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)
time frame: 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
time frame: Before the Project Viva pregnancy and 1-year postpartum
Child metabolic risk score, calculated as a standard deviation (SD) score
time frame: 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)
time frame: 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
time frame: Interviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).

Secondary Outcomes

Child's birth length in cm
time frame: Measured at birth
Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data
time frame: Measured at birth

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Project Viva: a Longitudinal Study of Health for the Next Generation
Principal investigator Emily Oken, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Harvard Pilgrim Health Care.