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

Pediatric Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02820402
• Other study ID #: 5R37HD034568
• Status: Active, not recruiting
• Start date: January 1999
• Est. completion date: August 2027

Study information

• Verified date: March 2023
• Source: Harvard Pilgrim Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2128
• Est. completion date: August 2027
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Obesity

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Harvard Pilgrim Health Care	Brigham and Women's Hospital, Harvard School of Public Health (HSPH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	Research measurements at birth, 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
Primary	Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight	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.	Before the Project Viva pregnancy and 1-year postpartum
Primary	Child metabolic risk score, calculated as a standard deviation (SD) score	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).	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.
Primary	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)		Children completed both the WRAML2 and the KBIT-2 at the mid-childhood visit (~8y)
Primary	Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease	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.	Interviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
Secondary	Child's birth length in cm		Measured at birth
Secondary	Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data		Measured at birth

External Links

•   Full publication list from Project Viva website