ANZCTR - Registration

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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]

Nil known

Secondary ID [2]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

genetic conditions

cardiometabolic conditions

respiratory conditions

immunological and inflammatory conditions

hormonal and reproduction conditions

musculoskeletal conditions

psychological conditions

vision conditions

hearing conditions

Condition category

Condition code

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Cardiovascular

Normal development and function of the cardiovascular system

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Respiratory

Normal development and function of the respiratory system

Inflammatory and Immune System

Normal development and function of the immune system

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Musculoskeletal

Normal musculoskeletal and cartilage development and function

Mental Health

Studies of normal psychology, cognitive function and behaviour

Eye

Normal eye development and function

Public Health

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Physical health status

for example:
Height was measured by neonatometer for infants and stadiometer for children and adults.

Timepoint [1]

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]

Mental health status

for example:
Child mental health was measured by parent-reported Child Behaviour Checklist

Timepoint [2]

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]

Behaviour outcomes

For example:
self reported physical activity was assessed by International Physical Activity Questionnaire

Timepoint [3]

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]

Social outcomes

For example:
Family income was assessed by questionnaire

Timepoint [1]

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]

Physical activity, sedentary behaviour, sleep 24 hour accelerometry

Timepoint [2]

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)

Recruitment hospital [1]

King Edward Memorial Hospital - Subiaco

Recruitment postcode(s) [1]

6008 - Subiaco

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council of Australia

Address [1]

16 Marcus Clarke St, Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Raine Medical Research Foundation

Address [2]

95 Monash Ave, Nedlands WA 6009

Country [2]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

35 Stirling Hwy, Crawley WA 6009

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Curtin University

Address [1]

Kent St, Bentley WA 6102

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Edith Cowan University

Address [2]

270 Joondalup Drive
Joondalup WA 6027

Country [2]

Australia

Secondary sponsor category [3]

University

Name [3]

Murdoch University

Address [3]

90 South Street
Murdoch WA 6150

Country [3]

Australia

Secondary sponsor category [4]

University

Name [4]

University of Notre Dame Australia

Address [4]

32 Mouat St, Fremantle WA 6160

Country [4]

Australia

Secondary sponsor category [5]

Other

Name [5]

Telethon Kids Institute

Address [5]

100 Roberts Rd, Subiaco WA 6008

Country [5]

Australia

Secondary sponsor category [6]

Charities/Societies/Foundations

Name [6]

Women and Infants Research Foundation

Address [6]

Carson House, King Edward Memorial Hospital
374 Bagot Road
Subiaco
WA 6008

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of King Edward Memorial Hospital

Ethics committee address [1]

***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]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/05/1989

Ethics approval number [1]

DD/JS/459

Ethics committee name [2]

Human Ethics, University of Western Australia

Ethics committee address [2]

*** 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]

Australia

Date submitted for ethics approval [2]

Approval date [2]

23/01/2015

Ethics approval number [2]

RA/4/1/7236

Ethics committee name [3]

Human Ethics, University of Western Australia

Ethics committee address [3]

***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]

Australia

Date submitted for ethics approval [3]

Approval date [3]

15/03/2016

Ethics approval number [3]

RA/4/1/8102

Ethics committee name [4]

Human Ethics, University of Western Australia

Ethics committee address [4]

***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]

Australia

Date submitted for ethics approval [4]

Approval date [4]

20/05/2016

Ethics approval number [4]

RA/4/1/8194

Ethics committee name [5]

University of Western Australian Human Research Committee

Ethics committee address [5]

35 Stirling Highway
Nedlands, WA 6009

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

05/06/2018

Ethics approval number [5]

RA/4/20/4390

Ethics committee name [6]

University of Western Australian Human Research Committee

Ethics committee address [6]

35 Stirling Highway
Nedlands
WA 6009

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

Approval date [6]

17/10/2018

Ethics approval number [6]

R4/4/20/4390

Ethics committee name [7]

The University of Western Australia Human Research Ethics Committee

Ethics committee address [7]

http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

Approval date [7]

08/11/2022

Ethics approval number [7]

2022/ET000177

Ethics committee name [8]

The University of Western Australia Human Research Ethics Committee

Ethics committee address [8]

http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

Approval date [8]

08/12/2023

Ethics approval number [8]

2023/ET000219

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, 27 and currently 33 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, Murdoch University, the Lions 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 being recruited and participating in assessments of developmental ability and physical activity. The other (non Raine Study) parent of the Gen 3 participant is also being recruited (Gen 2B).

Trial website

www.rainestudy.org.au

Trial related presentations / publications

Over 650 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]

/AnzctrAttachments/372325-RA_4_1_8184 Gen3 Application Approval May 2016.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/372325-2015_Raine Parents HREC approval.pdf (Ethics approval)

Attachments [3]

/AnzctrAttachments/372325-Gen2_27 Ethics Approval 2016.pdf (Ethics approval)

Attachments [4]

/AnzctrAttachments/372325-Raine antenatal_ethics approval 1989.pdf (Ethics approval)

Contacts

Principal investigator

Name

A/Prof Rebecca Glauert

Address

School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009

Country

Australia

Phone

+61 8 6488 6952

Fax

N/A

rebecca.glauert@uwa.edu.au

Contact person for public queries

Name

Romola Bucks

Address

School of Population and Global Health, Faculty of Health & Medical Sciences
M410, 14-16 Parkway, Crawley, WA 6009

Country

Australia

Phone

+61 8 6488 3232

Fax

N/A

romola.bucks@uwa.edu.au

Contact person for scientific queries

Name

Blagica Penova-Veselinovic

Address

The Raine Study House
University of Western Australia (M410)
14-16 Parkway,
Crawley,
WA 6009

Country

Australia

Phone

+61 8 6488 6952

Fax

N/A

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?

Doc. No.	Type	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

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Western Australian pregnancy cohort (Raine) Study: Generation 1	2019	https://doi.org/10.1136/bmjopen-2018-026276
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

N.B. These documents automatically identified may not have been verified by the study sponsor.

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