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 : November 12, 2019
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||2128 participants|
|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|
- 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.
- 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.
- 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).
- 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). ]
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…
- 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.
- 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 ]
Biospecimen Retention: Samples With DNA
Mom: 1st trimester-EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma); 2nd trimester-EDTA top (plasma, RBC, WBC-DNA), heparin top; birth - hair; early childhood-EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma); mid-teen-EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma, RBC), grey top (plasma), urine
Child: cord blood-heparin top (cell pellets and supernatant), serum, EDTA top (plasma, WBC-DNA); early childhood-EDTA top (plasma, WBC-DNA), heparin top (plasma, RBC); early childhood (Immune Substudy)-EDTA top, heparin top (room temp - stimulation supernatants, plasma), and heparin top (cold - RBC, plasma); mid-childhood-EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma, RBC), grey top (plasma), urine, hair; early teen - EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma, RBC), 2 ml grey top (plasma), urine, hair; mid-teen-EDTA top (plasma, RBC, WBC-DNA), heparin top (plasma, RBC), grey top (plasma), PAXgene blood RNA (RBC), baby teeth, urine, hair
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
|Principal Investigator:||Emily Oken, MD, MPH||Harvard Medical School / Harvard Pilgrim Health Care Institute|