Obesity Clinical Trial
— GenVOfficial title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Murdoch Children's Research Institute | Parkville | Victoria |
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 |
Australia,
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) |
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