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

Obesity Clinical Trial

— GenV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05394363
• Other study ID #: U1111-1269-3107
• Status: Recruiting
• Start date: October 4, 2021
• Est. completion date: October 2033

Study information

• Verified date: June 2023
• Source: Murdoch Childrens Research Institute
• Contact: GenV Cohort Coordinator
• Phone: +61 1800 436 888
• Email: genv[@]mcri.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200000
• Est. completion date: October 2033
• Est. primary completion date: October 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Australia	Murdoch Children's Research Institute	Parkville	Victoria

Sponsors (65)

Lead Sponsor

Collaborator

Murdoch Childrens Research Institute

Albury Wodonga Health, Angliss Health Service, Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service), Bairnsdale Regional Health Service, Bass Coast Regional Health, 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, Epworth Geelong, Frances Perry Private Hospital, Geelong University Hospital, Goulburn Valley Health, Grampians Health - Ballarat Base Hospital, Grampians Health - Horsham (formerly Wimmera Health Care Group), Hamilton Base Hospital, Jessie McPherson Private Hospital, Joan Kirner Women's and Children's Hospital, Latrobe Regional Hospital, Leongatha Memorial Hospital, Mansfield District Hospital, Maryborough District Health Service, Medical Research Future Fund, Mercy Hospital for Women, Mercy Werribee Public Hospital, Mildura Base Hospital, Mitcham Private Hospital, Monash Medical Centre, National Health and Medical Research Council, Australia, Northeast Health Wangaratta, Northpark Private Hospital, Peninsula Health, Peninsula Private Hospital, Portland District Health, Royal Children's Hospital, Royal Children's Hospital Foundation, 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, The Bays Private Hospital, The Kilmore & District Hospital, The Northern Hospital, The Paul Ramsay Foundation, University of Melbourne, Victoria State Government, Waverley Private Hospital, West Gippsland Healthcare Group, Yarrawonga District Health Service

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Generation Victoria (GenV) Website