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临床试验/NCT02820402
NCT02820402进行中(未招募)不适用

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

Harvard Pilgrim Health Care0 个研究点目标入组 2,128 人开始时间: 1999年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,128
主要终点
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)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Multiple gestation
  • Plans to move away before delivery
  • Plans to terminate the pregnancy

结局指标

主要结局

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)

时间窗: 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.

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)

时间窗: Children completed both the WRAML2 and the KBIT-2 at the mid-childhood visit (~8y)

Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight

时间窗: 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

时间窗: 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).

Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

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