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DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12617001599369
Ethics application status
Approved
Date submitted
19/06/2017
Date registered
5/12/2017
Date last updated
25/01/2023
Date data sharing statement initially provided
9/11/2018
Date results information initially provided
9/11/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
The Raine Study: A multi-generational, life-course study of health and well-being from before birth through to adulthood.
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Scientific title
The Raine Study: A multi-generational life-course study utilising rich genetic, phenotypic (cardiometabolic, respiratory, immunological, musculoskeletal, psychological, hormonal, reproductive, vision, hearing), behavioural (sleep, activity, diet, risky behaviour), environmental (chemical, spatial, social) and education and work data to improve human health and well-being.
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Secondary ID [1]
291136
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
genetic conditions
301968
0
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cardiometabolic conditions
301969
0
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respiratory conditions
301970
0
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immunological and inflammatory conditions
301971
0
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hormonal and reproduction conditions
301972
0
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musculoskeletal conditions
301973
0
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psychological conditions
301974
0
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vision conditions
301975
0
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hearing conditions
304836
0
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Condition category
Condition code
Human Genetics and Inherited Disorders
301619
301619
0
0
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Other human genetics and inherited disorders
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Cardiovascular
301620
301620
0
0
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Normal development and function of the cardiovascular system
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Metabolic and Endocrine
301621
301621
0
0
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Normal metabolism and endocrine development and function
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Respiratory
303712
303712
0
0
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Normal development and function of the respiratory system
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Inflammatory and Immune System
303713
303713
0
0
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Normal development and function of the immune system
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Reproductive Health and Childbirth
303714
303714
0
0
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Other reproductive health and childbirth disorders
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Musculoskeletal
303715
303715
0
0
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Normal musculoskeletal and cartilage development and function
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Mental Health
303716
303716
0
0
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Studies of normal psychology, cognitive function and behaviour
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Eye
303717
303717
0
0
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Normal eye development and function
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Public Health
303718
303718
0
0
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Epidemiology
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Four Generations are currently evolved in the Raine Study:
Generation 1 - women (and their partners) presenting to King Edward Memorial Hospital and surrounding private clinics in Perth, Western Australia who were between 16 and 20 weeks pregnant. 2,900 women were recruited between May 1989 and November 1991. In 2017 average age is 55 years (range 40-80). Assessments may continue every 3-5 years until death.
Generation 2 - live born children of the Generation 1 women (n=2868), These were born between August 1989 and May 1992, thus in 2017 average age is 27. Assessments are intended to continue every 3 years until death.
Generation 3 - live born children of Generation 2 women and men. As the Generation 3 children will be born over several decades, follow-up assessments may occur every 3-5 years rather than at specific ages. The intention is to follow this generation until death also.
Generation 0 - grandparents of Generation 2. Intention is to capture data on as many of this generation as possible before they are no longer able to participate in data collection.
Life-course exposures are being assessed.
For Generation 1 - exposures have been assessed at 18 and 36 weeks pregnancy, birth of their child, and when their child was 1, 2, 3, 5, 8, 10, 14, 17, and 26 years of age. The intention is to follow Generation 1 until death.
Behaviour exposures including sleep, activity (physical activity, sedentary behaviour), diet (diet, dietary behaviour), risky behaviour (drug use - alcohol, tobacco, other drugs, driving). Environment exposures, including chemical (for example hormones and endocrine disruptors) and medical exposures, such as ultrasounds and anaesthesia. Built and social environment including type of housing, neighbourhood and family relationships, and work.
For Generation 2 - exposures have been assessed at 18 and 36 weeks gestation, birth, and 1, 2, 3, 5, 8, 10, 14, 17, 20, 22, 27 and now 28 years of age. The intention is to regularly assess them until death.
Behaviour exposures including sleep, activity (physical activity, sedentary behaviour, technology use), diet (diet, dietary behaviour, breastfed), risky behaviour (drug use - alcohol, tobacco, other drugs, sexual behaviour, driving). Environment exposures including perinatal exposures such as obstetric factors; maternal nutrition, maternal exercise, maternal drugs (medications, smoking, alcohol, illicit), maternal stress and maternal mental health; chemical (such as endocrine disrupters and other pollutants), noise and sunlight exposure and medical procedure exposures (such as ultrasounds and anaesthesia). Built and social environment including neighbourhood security, parks, walkability, shops, fast food outlets, and family relationships, peer relationships, work colleague relationships.
For Generation 3 - exposures are being assessed at ages ranging between 2 and 10 years (approximately 200 Gen3 participants to date). The intention is to regularly assess all Generation 3.
Behaviour exposures including physical activity and diet. Environment exposures such as chemical exposures (including hormones and gut bacteria) and medical exposures. Social exposures, including family relationships and cognition.
For Generation 0 - sociodemographic, medical history, phenotypic data, behavioural exposure and environmental exposure data is being collected (approximately 100 Gen0 participants to date).
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Intervention code [1]
297116
0
Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
301017
0
Physical health status
for example:
Height was measured by neonatometer for infants and stadiometer for children and adults.
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Assessment method [1]
301017
0
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Timepoint [1]
301017
0
Generation 1 - across adulthood from pregnancy onwards. For example height was assessed at 5, 8, 14, 17 and 26 year follow-ups. Generation 2 - from 18 weeks gestation onwards across the life-course. For example height was assessed at follow-ups 1, 2, 3, 5, 8, 10, 14, 17, 20, 22, 27 years. Generation 3 - across the life-course. For example height at first follow-up. Generation 0 - at current collection
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Primary outcome [2]
301018
0
Mental health status
for example:
Child mental health was measured by parent-reported Child Behaviour Checklist
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Assessment method [2]
301018
0
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Timepoint [2]
301018
0
Generation 1 - across adulthood from pregnancy onwards. Generation 2 - from 18 weeks gestation onwards across the life-course. For example Child Behaviour Checklist was assessed at follow-ups 3, 5, 8, 10, 14 years. Generation 3 - across the life-course. Generation 0 - at current collection
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Primary outcome [3]
301019
0
Behaviour outcomes
For example:
self reported physical activity was assessed by International Physical Activity Questionnaire
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Assessment method [3]
301019
0
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Timepoint [3]
301019
0
Generation 1 - across adulthood from pregnancy onwards.
Generation 2 - from 18 weeks gestation onwards across the life-course.
For example International Physical Activity Questionnaire at 14, 17, 20, 22, 27 year follow-ups.
Generation 3 - across the life-course.
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Secondary outcome [1]
340209
0
Social outcomes
For example:
Family income was assessed by questionnaire
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Assessment method [1]
340209
0
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Timepoint [1]
340209
0
Generation 1 - across adulthood from pregnancy onwards. For example family income was assessed at birth, 1, 2, 3, 5, 8, 10, 14, 17 year follow-ups. Generation 2 - from 18 weeks gestation onwards across the life-course. For example personal income was assessed at 20, 22 and 27 year follow-ups Generation 3 - across the life-course. Generation 0 - at current collection.
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Secondary outcome [2]
340804
0
Physical activity, sedentary behaviour, sleep 24 hour accelerometry
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Assessment method [2]
340804
0
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Timepoint [2]
340804
0
Generation 1 26 years,
Generation 2 22 years
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Eligibility
Key inclusion criteria
Generation 1 - 18 weeks pregnant and attending King Edward Memorial Hospital in Perth, Western Australia or surrounding clinics during 1989-1991; anticipating giving birth in Perth; sufficiently understands English and gives consent.
Generation 2 - live born child of Generation 1 pregnancy listed above
Generation 3 - child of Generation 2
Generation 0 - grandparents of Generation 2
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Generation 1: Pregnancy did not result in live birth.
Generation 2: none.
Generation 3: none.
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Wide range of methods used including trajectory analyses.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
18/05/1989
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Date of last participant enrolment
Anticipated
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Actual
7/11/1991
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Date of last data collection
Anticipated
8/02/2117
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Actual
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Sample size
Target
2900
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Accrual to date
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Final
2868
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
7456
0
King Edward Memorial Hospital - Subiaco
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Recruitment postcode(s) [1]
15282
0
6008 - Subiaco
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Funding & Sponsors
Funding source category [1]
295574
0
Government body
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Name [1]
295574
0
National Health and Medical Research Council of Australia
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Address [1]
295574
0
16 Marcus Clarke St, Canberra ACT 2601
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Country [1]
295574
0
Australia
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Funding source category [2]
295575
0
Charities/Societies/Foundations
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Name [2]
295575
0
Raine Medical Research Foundation
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Address [2]
295575
0
95 Monash Ave, Nedlands WA 6009
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Country [2]
295575
0
Australia
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Primary sponsor type
University
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Name
University of Western Australia
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Address
35 Stirling Hwy, Crawley WA 6009
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Country
Australia
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Secondary sponsor category [1]
294401
0
University
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Name [1]
294401
0
Curtin University
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Address [1]
294401
0
Kent St, Bentley WA 6102
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Country [1]
294401
0
Australia
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Secondary sponsor category [2]
294402
0
University
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Name [2]
294402
0
Edith Cowan University
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Address [2]
294402
0
270 Joondalup Drive
Joondalup WA 6027
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Country [2]
294402
0
Australia
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Secondary sponsor category [3]
294403
0
University
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Name [3]
294403
0
Murdoch University
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Address [3]
294403
0
90 South Street
Murdoch WA 6150
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Country [3]
294403
0
Australia
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Secondary sponsor category [4]
294404
0
University
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Name [4]
294404
0
University of Notre Dame Australia
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Address [4]
294404
0
32 Mouat St, Fremantle WA 6160
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Country [4]
294404
0
Australia
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Secondary sponsor category [5]
294405
0
Other
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Name [5]
294405
0
Telethon Kids Institute
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Address [5]
294405
0
100 Roberts Rd, Subiaco WA 6008
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Country [5]
294405
0
Australia
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Secondary sponsor category [6]
294406
0
Charities/Societies/Foundations
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Name [6]
294406
0
Women and Infants Research Foundation
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Address [6]
294406
0
Carson House, King Edward Memorial Hospital
374 Bagot Road
Subiaco
WA 6008
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Country [6]
294406
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297944
0
Ethics Committee of King Edward Memorial Hospital
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Ethics committee address [1]
297944
0
***NOTE: Original ethics approval for Generation 1 and Generation2: "The origins of disease in the fetus, the child, and the young adults: A Western Australian Pregnancy Cohort Study"***
Ethics Committee of King Edward Memorial Hospital, Bagot Road, Subiaco WA 6008
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Ethics committee country [1]
297944
0
Australia
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Date submitted for ethics approval [1]
297944
0
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Approval date [1]
297944
0
18/05/1989
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Ethics approval number [1]
297944
0
DD/JS/459
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Ethics committee name [2]
297946
0
Human Ethics, University of Western Australia
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Ethics committee address [2]
297946
0
*** NOTE: Ethics approval for recent full follow-up of Generation 1: "Adult sleep study: Prevalence, phenotype & genotype of common sleep disorders"***
Human Ethics, University of Western Australia
The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia
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Ethics committee country [2]
297946
0
Australia
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Date submitted for ethics approval [2]
297946
0
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Approval date [2]
297946
0
23/01/2015
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Ethics approval number [2]
297946
0
RA/4/1/7236
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Ethics committee name [3]
298000
0
Human Ethics, University of Western Australia
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Ethics committee address [3]
298000
0
***NOTE: Ethics approval for recent follow-up of Generation 2: " The Western Australian Pregnancy Cohort (Raine) Study (Gen 2) 27 Year follow up (Raine Study Gen2: 27 year cohort follow up)"
Human Ethics, University of Western Australia
The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia
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Ethics committee country [3]
298000
0
Australia
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Date submitted for ethics approval [3]
298000
0
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Approval date [3]
298000
0
15/03/2016
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Ethics approval number [3]
298000
0
RA/4/1/8102
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Ethics committee name [4]
298002
0
Human Ethics, University of Western Australia
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Ethics committee address [4]
298002
0
***NOTE: Ethics approval for Generation 3: "Raine Study Gen 3: Assessment of Raine Study offspring, a partnership with the Autism CRC" ***
Human Ethics, University of Western Australia
The University of Western Australia
M459, 35 Stirling Highway
Crawley WA 6009 Australia
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Ethics committee country [4]
298002
0
Australia
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Date submitted for ethics approval [4]
298002
0
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Approval date [4]
298002
0
20/05/2016
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Ethics approval number [4]
298002
0
RA/4/1/8194
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Ethics committee name [5]
301890
0
University of Western Australian Human Research Committee
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Ethics committee address [5]
301890
0
35 Stirling Highway
Nedlands, WA 6009
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Ethics committee country [5]
301890
0
Australia
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Date submitted for ethics approval [5]
301890
0
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Approval date [5]
301890
0
05/06/2018
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Ethics approval number [5]
301890
0
RA/4/20/4390
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Ethics committee name [6]
301891
0
University of Western Australian Human Research Committee
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Ethics committee address [6]
301891
0
35 Stirling Highway
Nedlands
WA 6009
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Ethics committee country [6]
301891
0
Australia
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Date submitted for ethics approval [6]
301891
0
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Approval date [6]
301891
0
17/10/2018
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Ethics approval number [6]
301891
0
R4/4/20/4390
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Summary
Brief summary
In 1989 Professor John Newnham and colleagues invited more than 3000 pregnant women to join a National Health and Medical Research Council funded research study at King Edward Memorial Hospital to examine the possible beneficial effects of repeated fetal ultrasound imaging studies. Women were allocated at random into one of two groups – Regular Care or Intensive Care. Those in the Regular Care group had a single ultrasound imaging study at 18 weeks gestation, with further scans only if clinically indicated. The women in the Intensive Care group had ultrasound scans at 18, 24, 28, 34 and 38 weeks gestation. Along with Professor Newnham, a group of prominent investigators (Professor Fiona Stanley, Professor Lou Landau and Professor Con Michael) formed a group to establish these families into a cohort study, focusing on the child, to determine how events during pregnancy and childhood influence health in later life. This was initially supported with funding from the Raine Medical Research Foundation. The original cohort of 2868 children (Generation 2), is one of the largest, most successful prospective cohorts of pregnancy, childhood, adolescence and now adulthood to be carried out anywhere in the world. This cohort has provided environmental, developmental and health information over the past 27 years providing a unique and valuable resource covering a wide range of health areas. Follow-up assessment of the cohort has been conducted at birth, 1, 2, 3, 5, 8, 10, 14, 17, 18, 20, 22 and 27 years of age by a collaborative team of researchers from The University of Western Australia, Women and Infants Research Foundation, Telethon Kids Institute, Curtin University, Edith Cowan University, the University of Notre Dame, (and now also Murdoch University), the Lyons Eye Institute, and many other national and international collaborators. The original parents (Generation 1) participated in the assessments as well, providing information about their children and about themselves. Generation 1 has recently participated in assessments of sleep, obesity and activity. In addition, the off-spring (Generation 3) of the original cohort (Generation 2) are currently participating in assessments of developmental ability and physical activity.
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Trial website
www.rainestudy.org.au
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Trial related presentations / publications
Over 500 peer-reviewed papers have been published on the Raine Study. Please see full list on website. Key publications include:
Newnham JP, Evans SF, Michael CA, Stanley FJ, Landau LI. 1993 Effects of frequent ultrasound during pregnancy: a randomised controlled trial. Lancet;342:887–91
Straker, L, G Hall, J Mountain, E Howie, E White, N McArdle, and P Eastwood. 2015. 'Rationale, design and methods for the 22 year follow-up of the Western Australian Pregnancy Cohort (Raine) Study', BMC Public Health, 15: 663.
Straker, L, J Mountain, A Jacques, S White, A Smith, L Landau, F Stanley, J Newnham, C Pennell, and P Eastwood.. 2017 'Cohort Profile: The Western Australian Pregnancy Cohort (Raine) Study - Generation 2', International Journal of Epidemiology, 46(5), 1384-1385j.
White, S, P Eastwood, L Straker, L Adams, J Newnham, S Lye, and C Pennell. 2017. 'Monitoring perinatal selection bias with the passing decades of the Western Australian Pregnancy Cohort (Raine) Study', BMC Pregnancy and Childbirth, 17: 207.
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Public notes
There are approximately 30,000 historical variables stored for each Generation 2 participant (not including the approximately 30 million genetic data points). These variables, and those of Generation 0, 1 and 3, are currently being checked and organised into a relational database. Once this has been completed a full list of available outcomes will be made available with this registry listing. Current updates on variables are available at the Raine Study website. It is anticipated this full list of variables will be available in December 2019.
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Attachments [1]
1789
1789
0
0
/AnzctrAttachments/372325-RA_4_1_8184 Gen3 Application Approval May 2016.pdf
(Ethics approval)
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Attachments [2]
1791
1791
0
0
/AnzctrAttachments/372325-2015_Raine Parents HREC approval.pdf
(Ethics approval)
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Attachments [3]
1802
1802
0
0
/AnzctrAttachments/372325-Gen2_27 Ethics Approval 2016.pdf
(Ethics approval)
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Attachments [4]
1915
1915
0
0
/AnzctrAttachments/372325-Raine antenatal_ethics approval 1989.pdf
(Ethics approval)
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Contacts
Principal investigator
Name
72358
0
A/Prof Rebecca Glauert
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Address
72358
0
School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009
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Country
72358
0
Australia
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Phone
72358
0
+61 8 6488 6952
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Fax
72358
0
N/A
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Email
72358
0
[email protected]
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Contact person for public queries
Name
72359
0
Prof Romola Bucks
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Address
72359
0
School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009
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Country
72359
0
Australia
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Phone
72359
0
+61 8 6488 3232
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Fax
72359
0
N/A
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Email
72359
0
[email protected]
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Contact person for scientific queries
Name
72360
0
Ms Blagica Penova-Veselinovic
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Address
72360
0
The Raine Study House
University of Western Australia (M410)
14-16 Parkway,
Crawley,
WA 6009
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Country
72360
0
Australia
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Phone
72360
0
+61 8 6488 6952
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Fax
72360
0
N/A
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Email
72360
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All Raine Study data is available for use in projects approved by the Raine Study through its Raine Online Submission System
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When will data be available (start and end dates)?
Data is available in 2019 and planned to be available forever
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Available to whom?
Data is available to investigators on approved projects, conditional on investigators agreeing to a code of conduct
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Available for what types of analyses?
no specific limitations on types of analyses that could be performed.
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How or where can data be obtained?
Researchers can apply to have a project approved at the Raine Study website via the Raine Online Submission System.
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What supporting documents are/will be available?
No Supporting Document Provided
Current supporting documents:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
180
Ethical approval
Ethics approval for Generation 1 most recent data ...
[
More Details
]
372325-(Uploaded-09-11-2018-10-51-59)-Study-related document.pdf
181
Ethical approval
Ethics approval for data collection on Generation ...
[
More Details
]
372325-(Uploaded-09-11-2018-10-53-16)-Study-related document.pdf
14731
Ethical approval
372325-(Uploaded-18-01-2022-13-56-54)-Study-related document.pdf
Updated to:
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
180
Ethical approval
Ethics approval for Generation 1 and 2 most recent...
[
More Details
]
372325-(Uploaded-06-05-2024-15-34-25)-Study-related document.pdf
181
Ethical approval
Ethics approval for data collection on Generation ...
[
More Details
]
372325-(Uploaded-06-05-2024-15-36-23)-Study-related document.pdf
14731
Ethical approval
372325-(Uploaded-18-01-2022-13-56-54)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
Current Study Results
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
over 500 peer-reviewed papers have been published ...
[
More Details
]
Other files
No
100's of presentations have been given to scientif...
[
More Details
]
Update to Study Results
Doc. No.
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
20
Study results article
Yes
over 500 peer-reviewed papers have been published ...
[
More Details
]
21
Other files
No
100's of presentations have been given to scientif...
[
More Details
]
3044
Plain language summary
No
The Raine Study data has enabled many discoveries ...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Evaluating Distribution of Foveal Avascular Zone Parameters Corrected by Lateral Magnification and Their Associations with Retinal Thickness.
2022
https://dx.doi.org/10.1016/j.xops.2022.100134
Dimensions AI
Western Australian pregnancy cohort (Raine) Study: Generation 1
2019
https://doi.org/10.1136/bmjopen-2018-026276
N.B. These documents automatically identified may not have been verified by the study sponsor.
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