Trial Review

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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
2/09/2024
Date data sharing statement initially provided
9/11/2018
Date results 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.
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.
Secondary ID [1] 291136 0
Nil known
Secondary ID [2] 312868 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
genetic conditions 301968 0
cardiometabolic conditions 301969 0
respiratory conditions 301970 0
immunological and inflammatory conditions 301971 0
hormonal and reproduction conditions 301972 0
musculoskeletal conditions
 301973 0
psychological conditions 301974 0
vision conditions 301975 0
hearing conditions 304836 0
Condition category
Condition code
Human Genetics and Inherited Disorders 301619 301619 0 0
Other human genetics and inherited disorders
Cardiovascular 301620 301620 0 0
Normal development and function of the cardiovascular system
Metabolic and Endocrine 301621 301621 0 0
Normal metabolism and endocrine development and function
Respiratory 303712 303712 0 0
Normal development and function of the respiratory system
Inflammatory and Immune System 303713 303713 0 0
Normal development and function of the immune system
Reproductive Health and Childbirth 303714 303714 0 0
Other reproductive health and childbirth disorders
Musculoskeletal 303715 303715 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 303716 303716 0 0
Studies of normal psychology, cognitive function and behaviour
Eye 303717 303717 0 0
Normal eye development and function
Public Health 303718 303718 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Four Generations are currently involved 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 was 56 years (range 40-80). Assessments may continue every 3-5 years until death. Enrolment for Generation 1 participants is closed; they can choose to participate in any / all follow-up assessments.

Generation 2 - live born children of the Generation 1 women (n=2868), These were born between August 1989 and May 1992, thus in 2023 average age is 33. Assessments are intended to continue every 3 years until death. Enrolment of Generation 2 participants are closed; they can choose to participate in any / all follow-up assessments.

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. Enrolment of Gen 3 participants is ongoing, as they are born. The intention is to follow this generation until death also.

Generation 2B - the other biological parent of the Generation 3 participant. The intention is to collect information on Gen 2B parents every 3-5 years. Due to Gen 3 enrolment being ongoing, the enrolment of Gen2B is ongoing 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. Exposures are currently being assessed as part of the Generations follow-up (age of child is 33 years). 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 28 years of age. The current 33 year follow-up commenced in 2023. 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 0 and 18 years. The intention is to regularly assess all Generation 3 every 3-5 years.
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 2B - medical history, sociodemographic, phenotypic, behavioural and environmental exposure data is being collected.

For Generation 0 - sociodemographic, medical history, phenotypic data, behavioural exposure and environmental exposure data is being collected (approximately 100 Gen0 participants to date).
Intervention code [1] 297116 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301017 0
Physical health status

for example:
Height was measured by neonatometer for infants and stadiometer for children and adults.
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
Primary outcome [2] 301018 0
Mental health status

for example:
Child mental health was measured by parent-reported Child Behaviour Checklist
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
Primary outcome [3] 301019 0
Behaviour outcomes

For example:
self reported physical activity was assessed by International Physical Activity Questionnaire
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.
Secondary outcome [1] 340209 0
Social outcomes

For example:
Family income was assessed by questionnaire
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.
Secondary outcome [2] 340804 0
Physical activity, sedentary behaviour, sleep 24 hour accelerometry
Timepoint [2] 340804 0
Generation 1 26 years,
Generation 2 22 years

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 - all biological children of Generation 2 participants

Generation 2B - other biological parent of the Generation 3 participant

Generation 0 - grandparents of Generation 2
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Generation 1: Pregnancy did not result in live birth.

Generation 2: none.

Generation 3: none.

Generation 2B: none

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Wide range of methods used including trajectory analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/05/1989
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/02/2117
Actual
Sample size
Target
5000
Accrual to date
3768
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 7456 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 15282 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 295574 0
Government body
Name [1] 295574 0
National Health and Medical Research Council of Australia
Country [1] 295574 0
Australia
Funding source category [2] 295575 0
Charities/Societies/Foundations
Name [2] 295575 0
Raine Medical Research Foundation
Country [2] 295575 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
35 Stirling Hwy, Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 294401 0
University
Name [1] 294401 0
Curtin University
Address [1] 294401 0
Kent St, Bentley WA 6102
Country [1] 294401 0
Australia
Secondary sponsor category [2] 294402 0
University
Name [2] 294402 0
Edith Cowan University
Address [2] 294402 0
270 Joondalup Drive
Joondalup WA 6027
Country [2] 294402 0
Australia
Secondary sponsor category [3] 294403 0
University
Name [3] 294403 0
Murdoch University
Address [3] 294403 0
90 South Street
Murdoch WA 6150
Country [3] 294403 0
Australia
Secondary sponsor category [4] 294404 0
University
Name [4] 294404 0
University of Notre Dame Australia
Address [4] 294404 0
32 Mouat St, Fremantle WA 6160
Country [4] 294404 0
Australia
Secondary sponsor category [5] 294405 0
Other
Name [5] 294405 0
Telethon Kids Institute
Address [5] 294405 0
100 Roberts Rd, Subiaco WA 6008
Country [5] 294405 0
Australia
Secondary sponsor category [6] 294406 0
Charities/Societies/Foundations
Name [6] 294406 0
Women and Infants Research Foundation
Address [6] 294406 0
Carson House, King Edward Memorial Hospital
374 Bagot Road
Subiaco
WA 6008
Country [6] 294406 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297944 0
Ethics Committee of King Edward Memorial Hospital
Ethics committee address [1] 297944 0
Ethics committee country [1] 297944 0
Australia
Date submitted for ethics approval [1] 297944 0
Approval date [1] 297944 0
18/05/1989
Ethics approval number [1] 297944 0
DD/JS/459
Ethics committee name [2] 297946 0
Human Ethics, University of Western Australia
Ethics committee address [2] 297946 0
Ethics committee country [2] 297946 0
Australia
Date submitted for ethics approval [2] 297946 0
Approval date [2] 297946 0
23/01/2015
Ethics approval number [2] 297946 0
RA/4/1/7236
Ethics committee name [3] 298000 0
Human Ethics, University of Western Australia
Ethics committee address [3] 298000 0
Ethics committee country [3] 298000 0
Australia
Date submitted for ethics approval [3] 298000 0
Approval date [3] 298000 0
15/03/2016
Ethics approval number [3] 298000 0
RA/4/1/8102
Ethics committee name [4] 298002 0
Human Ethics, University of Western Australia
Ethics committee address [4] 298002 0
Ethics committee country [4] 298002 0
Australia
Date submitted for ethics approval [4] 298002 0
Approval date [4] 298002 0
20/05/2016
Ethics approval number [4] 298002 0
RA/4/1/8194
Ethics committee name [5] 301890 0
University of Western Australian Human Research Committee
Ethics committee address [5] 301890 0
Ethics committee country [5] 301890 0
Australia
Date submitted for ethics approval [5] 301890 0
Approval date [5] 301890 0
05/06/2018
Ethics approval number [5] 301890 0
RA/4/20/4390
Ethics committee name [6] 301891 0
University of Western Australian Human Research Committee
Ethics committee address [6] 301891 0
Ethics committee country [6] 301891 0
Australia
Date submitted for ethics approval [6] 301891 0
Approval date [6] 301891 0
17/10/2018
Ethics approval number [6] 301891 0
R4/4/20/4390
Ethics committee name [7] 316044 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [7] 316044 0
Ethics committee country [7] 316044 0
Australia
Date submitted for ethics approval [7] 316044 0
Approval date [7] 316044 0
08/11/2022
Ethics approval number [7] 316044 0
2022/ET000177
Ethics committee name [8] 316045 0
The University of Western Australia Human Research Ethics Committee
Ethics committee address [8] 316045 0
Ethics committee country [8] 316045 0
Australia
Date submitted for ethics approval [8] 316045 0
Approval date [8] 316045 0
08/12/2023
Ethics approval number [8] 316045 0
2023/ET000219

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1789 1789 0 0
/AnzctrAttachments/372325-RA_4_1_8184 Gen3 Application Approval May 2016.pdf (Ethics approval)
Attachments [2] 1791 1791 0 0
/AnzctrAttachments/372325-2015_Raine Parents HREC approval.pdf (Ethics approval)
Attachments [3] 1802 1802 0 0
/AnzctrAttachments/372325-Gen2_27 Ethics Approval 2016.pdf (Ethics approval)
Attachments [4] 1915 1915 0 0
/AnzctrAttachments/372325-Raine antenatal_ethics approval 1989.pdf (Ethics approval)

Contacts
Principal investigator
Name 72358 0
A/Prof Rebecca Glauert
Address 72358 0
School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009
Country 72358 0
Australia
Phone 72358 0
+61 8 6488 6952
Fax 72358 0
N/A
Email 72358 0
[email protected]
Contact person for public queries
Name 72359 0
Romola Bucks
Address 72359 0
School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009
Country 72359 0
Australia
Phone 72359 0
+61 8 6488 3232
Fax 72359 0
N/A
Email 72359 0
[email protected]
Contact person for scientific queries
Name 72360 0
Blagica Penova-Veselinovic
Address 72360 0
The Raine Study House
University of Western Australia (M410)
14-16 Parkway,
Crawley,
WA 6009
Country 72360 0
Australia
Phone 72360 0
+61 8 6488 6952
Fax 72360 0
N/A
Email 72360 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Data is available in 2019 and planned to be available forever
Available to whom?
Data is available to investigators on approved projects, conditional on investigators agreeing to a code of conduct
Available for what types of analyses?
no specific limitations on types of analyses that could be performed.
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.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIWestern Australian pregnancy cohort (Raine) Study: Generation 12019https://doi.org/10.1136/bmjopen-2018-026276
EmbaseEvaluating Distribution of Foveal Avascular Zone Parameters Corrected by Lateral Magnification and Their Associations with Retinal Thickness.2022https://dx.doi.org/10.1016/j.xops.2022.100134
N.B. These documents automatically identified may not have been verified by the study sponsor.