Clinical trial NCT05394363: Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Official title: Generation Victoria Cohort 2020s. A Statewide Longitudinal Cohort of Victorian Children and Their Parents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mental Health
Child Wellbeing
Infant Health
Child Health
Reproductive Health
Healthy Aging
Health Equity
Quality of Life
Social Determinants of Health
Environmental Exposure
Genetics
Cognition
Learning
Child Development
Congenital Abnormalities
Disability
Injuries
Communicable Diseases
Noncommunicable Diseases
Physical Fitness
Diet
Obesity
Allergy and Immunology
Inflammation
Intergenerational Relations
Keywords: Generation Victoria
GenV
Cohort Studies
Data Collection
Data Linkage
Child Health
Midlife Health
Children
Infants
Family
Parents
Mothers
Fathers
Life course perspective
Population Health
Longitudinal Studies
Genetics, population
Demography
Epidemiology
Health Disparity
Minority Health
Vulnerable Populations
Health Equity
Clinical Trial
Randomized Controlled Trial
Pragmatic Clinical Trial
Health Services Research
Economic Models
Value of Life
Geographic Information Systems
Social Determinants of Health
Climate Change
Built Environment
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: The Paul Ramsay Foundation
name: Royal Children's Hospital
name: Victoria State Government
name: Royal Children's Hospital Foundation
name: University of Melbourne
name: National Health and Medical Research Council, Australia
name: Medical Research Future Fund
name: Angliss Health Service
name: Bairnsdale Regional Health Service
name: Grampians Health - Ballarat Base Hospital
name: Bass Coast Regional Health
name: The Bays Private Hospital
name: Benalla & District Memorial Hospital
name: Bendigo Hospital
name: Box Hill Hospital
name: Cabrini Private Hospital
name: Casey Hospital
name: Castlemaine Hospital
name: Central Gippsland Health Service
name: Colac Area Health
name: Dandenong Hospital
name: Bacchus Marsh - Western Health (formerly Djerriwarrh Health Service)
name: East Grampians Health Service
name: Echuca Regional Health
name: Epworth Freemason's Private Hospital
name: Frances Perry Private Hospital
name: Peninsula Health
name: Epworth Geelong
name: Geelong University Hospital
name: Goulburn Valley Health
name: Hamilton Base Hospital
name: Jessie McPherson Private Hospital
name: Joan Kirner Women's and Children's Hospital
name: The Kilmore & District Hospital
name: Latrobe Regional Hospital
name: Leongatha Memorial Hospital
name: Mansfield District Hospital
name: Maryborough District Health Service
name: Mercy Hospital for Women
name: Mercy Werribee Public Hospital
name: Mildura Base Hospital
name: Mitcham Private Hospital
name: Monash Medical Centre
name: Northeast Health Wangaratta
name: The Northern Hospital
name: Northpark Private Hospital
name: Peninsula Private Hospital
name: Royal Women's Hospital
name: Sandringham & District Memorial Hospital
name: South Gippsland Hospital
name: South West Healthcare Camperdown
name: South West Healthcare Warnambool
name: St John of God Hospital Ballarat
name: St John of God Hospital Bendigo
name: St John of God Hospital Berwick
name: St John of God Hospital Geelong
name: St Vincents Private Hospital
name: Swan Hill District Hospital
name: Waverley Private Hospital
name: West Gippsland Healthcare Group
name: Grampians Health - Horsham (formerly Wimmera Health Care Group)
name: Albury Wodonga Health
name: Yarrawonga District Health Service
name: Portland District Health
First posted: 2022-05-27
Enrollment: 200000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of parents and children enrolled in the GenV Cohort 2020s
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of participants with complete data collection at each wave
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of participants with successful data linkage at each wave
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of participants with the targeted biosamples received at each wave
timeFrame: Point of consent until study completion (up to 10 years)
Secondary outcomes:
measure: Number of applications to access and analyse GenV end-user datasets
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of collaborative observational research studies supported
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of collaborative interventional research studies supported
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of participants involved in concurrent observational research studies embedded within or alongside GenV
timeFrame: Point of consent until study completion (up to 10 years)
measure: Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
timeFrame: Point of consent until study completion (up to 10 years)
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Murdoch Children's Research Institute
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Melissa Wake, MBChB, FRACP, FAHMS, MD
role: PRINCIPAL_INVESTIGATOR
References: