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Active, Not Recruiting

NCT Number: NCT02820402

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pediatric Obesity Asthma Behavior Body Weight Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiratory Hypersensitivity Respiratory Tract Diseases Signs and Symptoms

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

    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.

  2. 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

    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.

  3. 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.

    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).

  4. 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)

  5. 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).

    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.

Secondary outcomes

  1. Child's birth length in cm

    Time frame: Measured at birth

  2. 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

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Brigham and Women's Hospital
  • Harvard School of Public Health (HSPH)

Registry information

Important dates

Study start
1999
Primary completion
2027
Study completion
2027
First posted
Jul 1, 2016
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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