Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents (GenV)

Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions, exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.

The GenV Cohort 2020s is open to all babies born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of babies born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

Study Overview

• Status: Recruiting
• Conditions: Communicable Diseases; Quality of Life; Inflammation; Obesity; Congenital Abnormalities; Genetics; Healthy Aging; Child Development; Diet; Mental Health; Disability; Injuries; Cognition; Child Health; Environmental Exposure; Noncommunicable Diseases; Physical Fitness; Intergenerational Relations; Social Determinants of Health; Learning; Reproductive Health; Child Wellbeing; Infant Health; Health Equity; Allergy and Immunology

Detailed Description

GenV aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. GenV's key features ('building blocks') are:

• Consent - Consent soon after birth, targeting every family having a baby in Victoria across in a 2-year period;
• Biosamples - Curation of universal biosamples already collected and stored, and new biosamples collected directly by GenV;
• Linked data - Ongoing access to extensive administrative, service, clinical and geospatial datasets, including prospectively-collected preconception and prenatal datasets;
• GenV-collected data - Information collected from participants via GenV and/or in partnership with services, and face-to-face direct assessment once at school;
• Integrated studies - Collaborative research involving GenV participants in concurrent research studies embedded within or alongside GenV, with ethically supported agreements and data sharing arrangements (for example, trials, other interventional studies, depth sub-cohorts, registry-type research);
• Platform as a service - Safe and efficient platforms and processes that support diverse users to access and/or analyse the resources and datasets generated by GenV to maximise their benefit to human health, and support GenV to meet its commitment to transparency and Open Science.

GenV focuses on 10 big issues: COVID, healthy pregnancy, healthy newborns, equity, climate & environment, mental health, healthy development, allergy & immunity, infection, and obesity & diabetes, with a cross cutting commitment of population genomics. These focus areas drive current planning for data collection but are not intended to be exhaustive and may change over the life of the project.

GenV is working with partners at all birthing hospitals across Victoria (ie 58 hospital sites). Recruitment visits are completed by trained study staff with clinical and/or research backgrounds at the participant's hospital or via virtual and/or self-guided recruitment after discharge (including initial GenV-collected data and biosamples). Participant-provided data will be collected digitally (e.g. via website or smart phone app) about four times per year from age 3 months to 1 year, then 6-12 monthly until 5 years, and is expected to take 3-20 minutes per session. A face-to-face visit is planned for when the index child is around 6 years of age, completed by trained study staff with clinical and/or research backgrounds. The project duration is expected to be at least 10 years and potentially lifelong for its participants, dependant on study funding and willingness to continue.

Based on Victoria's annual birth rate and estimated post-pandemic fall, GenV estimates that the sampling frame for the main Cohort 2020s will comprise 150,000 children, 150,000 'primary' biological parents, and 130,000 (i.e. for 90 percent of children) second parents. GenV is preparing for a recruitment sample of up to 90 percent of children while recognising that uptake as low as 13 percent would still be valuable (i.e. sufficient to detect odds ratios of around 1.5 for an outcome with 1.5 percent prevalence and an exposure with 20 percent prevalence). At submission of this registration, our target sample size is 200,000 participants (80,000 children, 80,000 primary parents and 40,000 second parents). This would represent a 53 percent uptake from our potential denominator of all 150,000 babies born over a 24-month period and their primary parent, and half that for their secondary parent.

• Study Type: Observational
• Enrollment (Estimated): 200000

Contacts and Locations

• Study Contact: Name: GenV Cohort Coordinator; Phone Number: +61 1800 436 888; Email: genv@mcri.edu.au
• Study Contact Backup: Name: GenV Cohort Design Lead; Phone Number: +61 3 9345 4738; Email: libby.hughes@mcri.edu.au

Study Locations

• Australia
  • Victoria
    • Parkville, Victoria, Australia, 3052
      • Recruiting
      • Murdoch Children'S Research Institute
      • Contact: GenV Infoline; Phone Number: 1800 436 888; Email: genv@mcri.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All children living in the state of Victoria, Australia, born between 4th October 2021 and 3rd October 2023, and their parents/guardians.

Description

Inclusion Criteria (Children):

• Birth date between 4th October 2021 and 3rd October 2023
• Live at the time of recruitment
• Residing in Victoria at the time of recruitment
• Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the child's behalf, who provides a signed and dated informed consent form (e.g. a parent/guardian)

Inclusion Criteria (Adults):

• Be a parent or guardian of a child who meets the eligibility criteria above
• Provide a signed and dated informed consent form or have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion criteria:

• Babies who are deceased at the time of recruitment (i.e. still born or died after birth) and their parents/guardians
• Families unable to provide informed consent in any of the languages available

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of parents and children enrolled in the GenV Cohort 2020s	Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)	Point of consent until study completion (up to 10 years)
Number of participants with complete data collection at each wave	Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository	Point of consent until study completion (up to 10 years)
Number of participants with successful data linkage at each wave	Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository	Point of consent until study completion (up to 10 years)
Number of participants with the targeted biosamples received at each wave	Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)	Point of consent until study completion (up to 10 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of applications to access and analyse GenV end-user datasets	Assessed by analysis of the GenV data access registry	Point of consent until study completion (up to 10 years)
Number of collaborative observational research studies supported	Assessed by analysis of GenV Integrated Studies Register	Point of consent until study completion (up to 10 years)
Number of collaborative interventional research studies supported	Assessed by analysis of GenV Integrated Studies Register	Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent observational research studies embedded within or alongside GenV	Assessed by analysis of shared study participant relationship management system data	Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV	Assessed by analysis of shared study participant relationship management system data	Point of consent until study completion (up to 10 years)

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: National Health and Medical Research Council, Australia; Royal Children's Hospital; University of Melbourne; Monash Medical Centre; Victoria State Government; Royal Children's Hospital Foundation; Medical Research Future Fund; Angliss Health Service; Bairnsdale Regional Health Service; Bass Coast Regional Health; The Bays Private Hospital; Benalla & District Memorial Hospital; Bendigo Hospital; Box Hill Hospital; Cabrini Private Hospital; Casey Hospital; Castlemaine Hospital; Central Gippsland Health Service; Colac Area Health; Dandenong Hospital; East Grampians Health Service; Echuca Regional Health; Epworth Freemason's Private Hospital; Frances Perry Private Hospital; Peninsula Health; Epworth Geelong; Geelong University Hospital; Goulburn Valley Health; Hamilton Base Hospital; Jessie McPherson Private Hospital; Joan Kirner Women's and Children's Hospital; The Kilmore & District Hospital; Latrobe Regional Hospital; Leongatha Memorial Hospital; Mansfield District Hospital; Maryborough District Health Service; Mercy Hospital for Women; Mercy Werribee Public Hospital; Mildura Base Hospital; Mitcham Private Hospital; Northeast Health Wangaratta; The Northern Hospital; Northpark Private Hospital; Peninsula Private Hospital; Royal Women's Hospital; Sandringham & District Memorial Hospital; South Gippsland Hospital; South West Healthcare Camperdown; South West Healthcare Warnambool; St John of God Hospital Ballarat; St John of God Hospital Bendigo; St John of God Hospital Berwick; St John of God Hospital Geelong; St Vincents Private Hospital; Swan Hill District Hospital; Waverley Private Hospital; West Gippsland Healthcare Group; Albury Wodonga Health; Yarrawonga District Health Service; Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service); Portland District Health; The Paul Ramsay Foundation; Grampians Health - Ballarat Base Hospital; Grampians Health - Horsham (formerly Wimmera Health Care Group)
• Investigators: Principal Investigator: Melissa Wake, MBChB, FRACP, FAHMS, MD, Murdoch Children'S Research Institute

Publications and helpful links

General Publications

• Hu YJ, Wake M, Saffery R. Clarifying the Sweeping Consequences of COVID-19 in Pregnant Women, Newborns, and Children With Existing Cohorts. JAMA Pediatr. 2021 Feb 1;175(2):117-118. doi: 10.1001/jamapediatrics.2020.2395. No abstract available.
• Wake M, Hu YJ, Warren H, Danchin M, Fahey M, Orsini F, Pacilli M, Perrett KP, Saffery R, Davidson A. Integrating trials into a whole-population cohort of children and parents: statement of intent (trials) for the Generation Victoria (GenV) cohort. BMC Med Res Methodol. 2020 Sep 24;20(1):238. doi: 10.1186/s12874-020-01111-x. Review.
• Wang J, Hu YJ, Clifford S, Goldfeld S, Wake M. Selecting life course frameworks to guide and communicate large new cohort studies: Generation Victoria (GenV) case study. J Dev Orig Health Dis. 2021 Dec;12(6):829-848. doi: 10.1017/S2040174420001245. Epub 2021 Jan 18. Review.
• Sung V, Williams K, Perlow E, Hu YJ, Ahern S, Said JM, Karanatsios B, Hopper JL, McNeil JJ, Donnan L, Goldfeld S, Wake M. Enhancing Value and Uptake for Whole-Population Cohorts of Children and Parents: Methods to Integrate Registries into the Generation Victoria Cohort. Children (Basel). 2021 Apr 7;8(4). pii: 285. doi: 10.3390/children8040285.
• Nkyekyer J, Clifford SA, Mensah FK, Wang Y, Chiu L, Wake M. Maximizing Participant Engagement, Participation, and Retention in Cohort Studies Using Digital Methods: Rapid Review to Inform the Next Generation of Very Large Birth Cohorts. J Med Internet Res. 2021 May 14;23(5):e23499. doi: 10.2196/23499. Review.
• Mavoa S, Keevers D, Kane SC, Wake M, Tham R, Lycett K, Wong YT, Chong K. Parental Preconception Exposures to Outdoor Neighbourhood Environments and Adverse Birth Outcomes: A Protocol for a Scoping Review and Evidence Map. Int J Environ Res Public Health. 2021 Aug 25;18(17). pii: 8943. doi: 10.3390/ijerph18178943.
• Bell J, Prictor M, Davenport L, O'Brien L, Wake M. Digital Mega-Studies as a New Research Paradigm: Governing the Health Research of the Future. J Empir Res Hum Res Ethics. 2021 Oct;16(4):344-355. doi: 10.1177/15562646211041492. Epub 2021 Sep 9.
• Musgrove E, Gasparini L, McBain K, Clifford SA, Carter SA, Teede H, Wake M. Synthesizing Core Outcome Sets for outcomes research in cohort studies: a systematic review. Pediatr Res. 2022 Oct;92(4):936-945. doi: 10.1038/s41390-021-01801-2. Epub 2021 Dec 17.
• Wake M, Goldfeld S, Davidson A. Embedding Life Course Interventions in Longitudinal Cohort Studies: Australia's GenV Opportunity. Pediatrics. 2022 May 1;149(Suppl 5):e2021053509R. doi: 10.1542/peds.2021-053509R. No abstract available.

Helpful Links

• Generation Victoria (GenV) Website

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Family; Minority Health; Children; Longitudinal Studies; Randomized Controlled Trial; Epidemiology; Health Services Research; Health Disparity; Clinical Trial; Parents; Infants; Social Determinants of Health; Population Health; Cohort Studies; Health Equity; Vulnerable Populations; Child Health; Data Collection; Mothers; Built Environment; Pragmatic Clinical Trial; Generation Victoria; GenV; Data Linkage; Midlife Health; Fathers; Life course perspective; Genetics, population; Demography; Economic Models; Value of Life; Geographic Information Systems; Climate Change
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Inflammation; Infections; Communicable Diseases; Congenital Abnormalities; Noncommunicable Diseases
• Other Study ID Numbers: U1111-1269-3107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

GenV is designed as an Open Science resource. Privacy-protected child and parent research data will be made available spanning:

• Individual physical and mental health, education, social and bioassay data
• Neighbourhood data (eg pollution, childcare)

Data will in general be made available after completion and data preparation for entire waves of data collection. An access policy is currently under development.

GenV's biosamples are small in volume and depletable. Therefore, bioassay requests are most likely to proceed if they:

• Are for all participants in GenV (or for the whole subgroup with that biosample)
• Would be valued by many researchers
• Generate broad, not hypothesis-specific, biodata (eg -omics panels)
• Are supported by funding and quality processes.

• IPD Sharing Time Frame: The first wave of data is expected to become available after the full GenV Cohort 2020s recruitment is complete (ie after October 2023 + allowing time for data preparation). Subsequent releases will follow completed waves of data collection, with each age-specific wave expected to be in the field for around 3 years (Vanguard + Cohort 2020s), and to then be available indefinitely. Limited data may be made available to some collaborators prior to this, for example to support specific operations of integrated studies.

IPD Sharing Access Criteria

Data will be made available to approved end-users for analyses that achieve the aims in the approved proposal. Approval is based on:

• The research aims to improve health, development, or wellbeing
• The proposed use of the data is covered by ethical approval
• GenV assesses the safety and expertise of the applicant and the institution/organisation
• Samples/data are used with participant privacy protection in place
• Users agree to GenV's conditions of use.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Study Protocol
   Information comments: Wake M, Goldfeld S, Saffery R; Siero W, Hughes E. Generation Victoria (GenV) Cohort 2020s Protocol In: Generation Victoria Figshare Project. Figshare 2021.
2. Informed Consent Form
   Information comments: Wake M, Goldfeld S, Saffery R; Siero W, Hughes E. Generation Victoria (GenV) Cohort 2020s Participant Information Statement and Consent Form In: Generation Victoria Figshare Project. Figshare 2021.
3. Generation Victoria (GenV) Cohort 2020s Statement of Intent
   Information comments: Wake M, Goldfeld S, Saffery R, Siero W, Lamb K, Stringer M, et al. Generation Victoria (GenV) Cohort 2020s Statement of Intent In: Generation Victoria Figshare Project. Figshare 2019.
4. Generation Victoria (GenV) Cohort 2020s Synopsis
   Information comments: Wake M, Goldfeld S, Saffery R, Siero W, Hourani D, Gulenc A, et al. Generation Victoria (GenV) Cohort 2020s Synopsis In: Generation Victoria Figshare Project. Figshare 2019.
5. Guidance and expressions of interest for enquires and proposals to collaborate with GenV
6. Working Papers relevant to GenV design, data sharing and researchers working with GenV
7. Published Papers relevant to GenV design, data sharing and researchers working with GenV
8. Current GenV collaborations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No