Clinical trial NCT02820402: Project Viva: a Longitudinal Study of Health for the Next Generation
Official title: Project Viva: a Longitudinal Study of Health for the Next Generation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Obesity
Keywords: Pregnancy
Obesity
Diet
Maternal/child health
Asthma/allergy
Air pollution
Epigenetics
Cognition/behavior
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: Harvard School of Public Health (HSPH)
First posted: 2016-07-01
Enrollment: 2128
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Research measurements at birth, 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
measure: Maternal post-partum weight retention, calculated as the difference between weight in kg at 1 year postpartum and pre-pregnancy weight
timeFrame: Before the Project Viva pregnancy and 1-year postpartum
measure: Child metabolic risk score, calculated as a standard deviation (SD) score
timeFrame: 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.
measure: 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)
timeFrame: Children completed both the WRAML2 and the KBIT-2 at the mid-childhood visit (~8y)
measure: Mother's report of a clinical diagnosis of asthma, wheeze or reactive airway disease
timeFrame: Interviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
Secondary outcomes:
measure: Child's birth length in cm
timeFrame: Measured at birth
measure: Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data
timeFrame: Measured at birth
Other outcomes:
Locations:
Study officials:
affiliation: Harvard Medical School / Harvard Pilgrim Health Care Institute
name: Emily Oken, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGovern C, Rifas-Shiman SL, Switkowski KM, Woo Baidal JA, Lightdale JR, Hivert MF, Oken E, Aris IM. Association of cow's milk intake in early childhood with adiposity and cardiometabolic risk in early adolescence. Am J Clin Nutr. 2022 Aug 4;116(2):561-571. doi: 10.1093/ajcn/nqac103.
citation: Wu AJ, Aris IM, Rifas-Shiman SL, Oken E, Taveras EM, Hivert MF. Longitudinal associations of fruit juice intake in infancy with DXA-measured abdominal adiposity in mid-childhood and early adolescence. Am J Clin Nutr. 2021 Jul 1;114(1):117-123. doi: 10.1093/ajcn/nqab043.
citation: Switkowski KM, Camargo CA, Rifas-Shiman SL, Fuller H, Oken E. Early-Life Factors Are Associated with Vitamin D Status in Early and Mid-Childhood and May Differ between White and Black Children. J Nutr. 2021 May 11;151(5):1256-1268. doi: 10.1093/jn/nxaa456.
citation: Turturice BA, Theorell J, Koenig MD, Tussing-Humphreys L, Gold DR, Litonjua AA, Oken E, Rifas-Shiman SL, Perkins DL, Finn PW. Perinatal granulopoiesis and risk of pediatric asthma. Elife. 2021 Feb 10;10:e63745. doi: 10.7554/eLife.63745.
citation: Mahmassani HA, Switkowski KM, Scott TM, Johnson EJ, Rifas-Shiman SL, Oken E, Jacques PF. Maternal Intake of Lutein and Zeaxanthin during Pregnancy Is Positively Associated with Offspring Verbal Intelligence and Behavior Regulation in Mid-Childhood in the Project Viva Cohort. J Nutr. 2021 Mar 11;151(3):615-627. doi: 10.1093/jn/nxaa348.
citation: Gingras V, Aris IM, Rifas-Shiman SL, Switkowski KM, Oken E, Hivert MF. Timing of Complementary Feeding Introduction and Adiposity Throughout Childhood. Pediatrics. 2019 Dec;144(6):e20191320. doi: 10.1542/peds.2019-1320.
citation: Switkowski KM, Jacques PF, Must A, Fleisch A, Oken E. Associations of protein intake in early childhood with body composition, height, and insulin-like growth factor I in mid-childhood and early adolescence. Am J Clin Nutr. 2019 Apr 1;109(4):1154-1163. doi: 10.1093/ajcn/nqy354.
citation: Gingras V, Rifas-Shiman SL, Taveras EM, Oken E, Hivert MF. Dietary behaviors throughout childhood are associated with adiposity and estimated insulin resistance in early adolescence: a longitudinal study. Int J Behav Nutr Phys Act. 2018 Dec 17;15(1):129. doi: 10.1186/s12966-018-0759-0.
citation: Gingras V, Rifas-Shiman SL, Derks IPM, Aris IM, Oken E, Hivert MF. Associations of Gestational Glucose Tolerance With Offspring Body Composition and Estimated Insulin Resistance in Early Adolescence. Diabetes Care. 2018 Dec;41(12):e164-e166. doi: 10.2337/dc18-1490. Epub 2018 Oct 16. No abstract available.
citation: Switkowski KM, Jacques PF, Must A, Hivert MF, Fleisch A, Gillman MW, Rifas-Shiman S, Oken E. Higher Maternal Protein Intake during Pregnancy Is Associated with Lower Cord Blood Concentrations of Insulin-like Growth Factor (IGF)-II, IGF Binding Protein 3, and Insulin, but Not IGF-I, in a Cohort of Women with High Protein Intake. J Nutr. 2017 Jul;147(7):1392-1400. doi: 10.3945/jn.117.250589. Epub 2017 Jun 7.
citation: Switkowski KM, Jacques PF, Must A, Kleinman KP, Gillman MW, Oken E. Maternal protein intake during pregnancy and linear growth in the offspring. Am J Clin Nutr. 2016 Oct;104(4):1128-1136. doi: 10.3945/ajcn.115.128421. Epub 2016 Aug 31.