Pediatric ObesityNCT02820402
Project Viva: a Longitudinal Study of Health for the Next Generation
An observational study of Pediatric Obesity, run by Harvard Pilgrim Health Care.
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. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Pediatric Obesity
- How many people
- 2,128 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Multiple gestation
- Plans to move away before delivery
- Plans to terminate the pregnancy
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity
- Keywords
- Pregnancy, Obesity, Diet, Maternal/child health, Asthma/allergy, Air pollution, Epigenetics, Cognition/behavior
- Medical subject headings
- Pediatric Obesity, Obesity, Asthma, Hypersensitivity, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Research measurements at birth, 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
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.
Measured: Before the Project Viva pregnancy and 1-year postpartum
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).
Measured: 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.
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)
Measured: 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
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.
Measured: Interviews administered at 6mo, early childhood (~3y), mid-childhood (~8y), early teen (~14y), and mid-late teen (~17y).
Secondary outcomes (2)
Child's birth length in cm
Measured: Measured at birth
Child's birth weight in grams, standardized into a sex- and gestational age-specific z-score using national reference data
Measured: Measured at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJan 1999
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Emily Oken, MD, MPH, Principal investigator, Harvard Medical School / Harvard Pilgrim Health Care Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820402
- Sponsor's protocol ID
- 5R37HD034568
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2016
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
Harnois-Leblanc S, Rifas-Shiman SL, Switkowski KM, Perng W, Aris IM, Oken E, Young JG, Hivert MF. Estimating sex-specific population-level effects of limiting sugar-sweetened beverages or 100% fruit juices during childhood on insulin resistance, central adiposity, and glycemic outcomes in late adolescence. Am J Epidemiol. 2026 Mar 5;195(3):850-858. doi: 10.1093/aje/kwaf225.
PubMed 41108089Switkowski KM, Kronsteiner-Gicevic S, Rifas-Shiman SL, Lightdale JR, Oken E. Evaluation of the Prime Diet Quality Score from Early Childhood Through Mid-Adolescence. J Nutr. 2024 Jun;154(6):1890-1906. doi: 10.1016/j.tjnut.2024.04.014. Epub 2024 Apr 16.
PubMed 38614240Choudhary D, Rideout TC, Cameron CE, Lehman HK, Oken E, Rifas-Shiman SL, Wen X. Egg Introduction during Infancy is Associated with Lower Fat Mass Index in Females at Early Adolescence. J Nutr. 2023 Jan;153(1):158-166. doi: 10.1016/j.tjnut.2022.11.003. Epub 2022 Dec 20.
PubMed 36913449McGovern 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.
PubMed 35441227Wu 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.
PubMed 33829237Switkowski 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.
PubMed 33693813Turturice 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.
PubMed 33565964Mahmassani 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.
PubMed 33484136Gingras 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.
PubMed 31757860Switkowski 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.
PubMed 30869114Gingras 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.
PubMed 30558613Gingras 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.
PubMed 30327360Switkowski 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.
PubMed 28592512Switkowski 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.
PubMed 27581477