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

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ClinicalTrials.gov Identifier: NCT02820402
Recruitment Status : Active, not recruiting
First Posted : July 1, 2016
Last Update Posted : August 16, 2017
Sponsor:
Collaborators:
Brigham and Women's Hospital
Harvard School of Public Health
Information provided by (Responsible Party):
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.

Condition or disease
Pediatric Obesity

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.

Study Type : Observational
Actual Enrollment : 2128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Project Viva: a Longitudinal Study of Health for the Next Generation
Study Start Date : January 1999
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021



Primary Outcome Measures :
  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…

    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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA

Mom: 1st trimester - EDTA purple top (plasma, RBC, WBC-DNA), heparin green top (plasma); 2nd trimester - EDTA purple top (plasma, RBC, WBC-DNA), heparin green top; birth - hair; age 3 (early childhood) - EDTA purple top (plasma, RBC, WBC-DNA), heparin green top (plasma)

Child: cord blood —heparin green top (cell pellets and supernatant), red top (serum), EDTA purple top (plasma, WBC-DNA); age 3 (early childhood) - EDTA purple top (plasma, WBC-DNA), heparin green top (plasma, RBC); age 3 (early childhood) Immune Substudy - EDTA purple top, heparin green top (room temp - stimulation supernatants, plasma), and heparin green top (cold - RBC, plasma); age 7 (mid childhood) - EDTA purple top (plasma, RBC, WBC-DNA), heparin green top (plasma, RBC), grey top (plasma), urine, hair; early teen - EDTA purple top (plasma, RBC, WBC-DNA), heparin green top (plasma, RBC), 2 ml grey top (plasma), urine, hair



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Mothers initially recruited during their first prenatal visit (median 9.9 wks gestation) at a multi-specialty group practice in eastern Massachusetts between 1999-2002 and their children.

Project Viva recruited 2670 women (64% of those who were approached for participation). 2,128 were still enrolled at the time of delivery and had live births, resulting in a cohort of 2,128 mother-child pairs.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02820402


Sponsors and Collaborators
Harvard Pilgrim Health Care
Brigham and Women's Hospital
Harvard School of Public Health
Investigators
Principal Investigator: Emily Oken, MD, MPH Harvard Medical School / Harvard Pilgrim Health Care Institute

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT02820402     History of Changes
Other Study ID Numbers: 5R37HD034568 ( U.S. NIH Grant/Contract )
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Project Viva protocols include a data sharing plan. The process for requesting data is detailed in the study policy document, available on the Project Viva website: https://www.hms.harvard.edu/viva/policies-for-using-our-data.pdf.

Keywords provided by Harvard Pilgrim Health Care:
Pregnancy
Obesity
Diet
Maternal/child health
Asthma/allergy
Air pollution
Epigenetics
Cognition/behavior

Additional relevant MeSH terms:
Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms