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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
13/11/2019
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.
Scientific title
The Western Australian Pregnancy (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
None
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 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).
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 - child of Generation 2

Generation 0 - grandparents of Generation 2
Minimum age
No limit
Maximum age
No limit
Gender
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.

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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
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
Address [1] 295574 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 295574 0
Australia
Funding source category [2] 295575 0
Charities/Societies/Foundations
Name [2] 295575 0
Raine Medical Research Foundation
Address [2] 295575 0
95 Monash Ave, Nedlands WA 6009
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
***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
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
*** 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
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
***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
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
***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
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
35 Stirling Highway
Nedlands, WA 6009
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
35 Stirling Highway
Nedlands
WA 6009
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

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.
Trial website
www.rainestudy.org.au
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.
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.
Attachments [1] 1789 1789 0 0
Attachments [2] 1791 1791 0 0
Attachments [3] 1802 1802 0 0
Attachments [4] 1915 1915 0 0

Contacts
Principal investigator
Name 72358 0
Prof Leon Straker
Address 72358 0
School of Physiotherapy and Exercise Science
Faculty of Health Science
Curtin University
GPO Box U1987 | Perth | WA 6845 | Australia
Country 72358 0
Australia
Phone 72358 0
+61 8 9266 4644
Fax 72358 0
N/A
Email 72358 0
L.Straker@curtin.edu.au
Contact person for public queries
Name 72359 0
Prof Peter Eastwood
Address 72359 0
School of Human Sciences
The University of Western Australia (M309)
35 Stirling Highway
CRAWLEY WA 6009
Country 72359 0
Australia
Phone 72359 0
+61 8 6457 1706
Fax 72359 0
+61 8 6457 2034
Email 72359 0
peter.eastwood@health.wa.gov.au
Contact person for scientific queries
Name 72360 0
Dr Juliana Zabatiero
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
rainestudy@uwa.edu.au

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?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 180 0
Ethical approval
Citation [1] 180 0
Link [1] 180 0
Email [1] 180 0
Other [1] 180 0
Ethics approval for Generation 1 most recent data collection
Type [2] 181 0
Ethical approval
Citation [2] 181 0
Link [2] 181 0
Email [2] 181 0
Other [2] 181 0
Ethics approval for data collection on Generation 0
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 148 0
over 500 peer-reviewed papers have been published on the Raine Study data. A list of publications is provided at: https://www.rainestudy.org.au/
Attachments [1] 148 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 149 0
Other
Citation/DOI/link/details [1] 149 0
100's of presentations have been given to scientific and community groups utilising the Raine Study data (no copies of presentations available).
Attachments [1] 149 0
Results – basic reporting
Results – plain English summary
The Raine Study data has enabled many discoveries related to health and well-being - and these have been reported in over 500 peer reviewed journal papers. Example discoveries include:

Established the safety of ultrasounds and the standard for routine prenatal ultrasound scanning worldwide.

Identified genes associated with lung function, birthweight, puberty and language development.

Found that children who were breastfed for four months or longer had a healthier weight, had less asthma and allergies and less behavioural problems.

Found that children with a better quality diet had better behaviour and better school achievement.

Found that low vitamin D levels put children and teenagers at an increased risk for both allergy and asthma, and this affects boys more than girls.

Found that work absenteeism is a significant issue for young adults and is associated with spinal pain and mental ill-health.

Identified trajectories characterised by higher TV viewing across childhood and adolescence predicted poorer physical and mental health in adulthood.