ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000931077

Ethics application status

Approved

Date submitted

2/11/2010

Date registered

2/11/2010

Date last updated

13/08/2019

Date data sharing statement initially provided

13/08/2019

Date results provided

13/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Environments for Healthy Living, Griffith Study of Population Health: Longitudinal Birth Cohort Study, Child Development and Health.

Scientific title

Environments for Healthy Living, Griffith Study of Population Health: Longitudinal Birth Cohort Study in South East Queensland and Tweed, Child Development and Health.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

EFHL: Environments for Healthy Living

Linked study record

Health condition

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

All cause Morbidity

Child Injury

Child Quality of Life

Obesity

Obstetric Complications and Birth weight

Child Development

Oral and Dental Health

Health Care Utilisation

Condition category

Condition code

Public Health

Epidemiology

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

This is a prospective, observational birth cohort study, which includes investigating social and environmental exposures, family functioning, child development, child injury, health service use and disease onset from birth to adulthood. Detailed information on each participant will be obtained at birth, 12-months, 3 years, 5 years and at subsequent three to five yearly intervals.

Intervention code [1]

Not applicable

Comparator / control treatment

Control group

Uncontrolled

Outcomes

Primary outcome [1]

All Cause Morbidity

Timepoint [1]

This will be measured by follow-up proxy reports at 12 months, 3 and 5 years and data linkage to medical records from birth to 5 years of age.

Secondary outcome [1]

Child Injury

Timepoint [1]

This will be measured by follow-up proxy reports at 12 months, 3 and 5 years and linkage to medical records at 5 years.

Secondary outcome [2]

Child Quality of Life

Timepoint [2]

This will be measured by proxy report using the Health Utilities Instrument mark 2 (HUI2)at 5 years. The HUI2 is a multi-attribute utility instrument to measure health-related quality of life on a scale of 0 (dead) to 1 (full health) in children

Secondary outcome [3]

Obesity

Timepoint [3]

Child height and weight will be measured by anthropomorphic assessments at 5 years.

Secondary outcome [4]

Obstetric Complications and Birth Weight

Timepoint [4]

This will be assessed from perinantal data records following birth.

Secondary outcome [5]

Child Development

Timepoint [5]

This will be measured by follow-up proxy reports and age appropriate child development scales at 12 months, 3 and 5 years.

Secondary outcome [6]

Health Care Utilisation

Timepoint [6]

This will be measured by data linkage to medical records from birth to 5 years of age.

Eligibility

Key inclusion criteria

a) Offspring of women aged 16 years or over residing within South East Queensland or Tweed NSW.
b) Planned birth at one of the three participating public hospitals (Gold Coast, Logan and The Tweed Hospitals).
c) Pregnant mothers recruited on or after 24 weeks gestation at their routine antenatal visit.
d) Offspring registered as a participant in the study at birth.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

a) Gestational period less than 24 weeks at the time of recruitment
b) Mother aged less than 16 years
c) Inability to provide informed consent

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/11/2006

Actual

2/11/2006

Date of last participant enrolment

Anticipated

Actual

20/11/2012

Date of last data collection

Anticipated

1/03/2019

Actual

1/05/2014

Sample size

Target

4000

Accrual to date

Final

2904

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

The Tweed Hospital - Tweed Heads

Recruitment hospital [2]

Gold Coast Hospital - Southport

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment postcode(s) [1]

4131

Recruitment postcode(s) [2]

4215

Recruitment postcode(s) [3]

2485

Funding & Sponsors

Funding source category [1]

University

Name [1]

Griffith University

Address [1]

Nathan campus Griffith University, 170 Kessels Road, Nathan, QLD 4111, Australia.

Country [1]

Australia

Primary sponsor type

University

Name

Griffith University

Address

Nathan campus Griffith University, 170 Kessels Road, Nathan, QLD 4111, Australia.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Professor Paul Scuffham

Address [1]

Centre for Applied Health Economics, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Professor Rod McClure

Address [2]

Professor of Public Health Medicine, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Cate Cameron

Address [3]

NHMRC Research Fellow, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Anneliese Spinks

Address [4]

CSIRO Sustainable Ecosystems, 306 Caromody Road, St Lucia, QLD 4067, Australia.

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Professor Andrew Wilson

Address [5]

Executive Dean, Faculty of Health, Queensland University of Technology, Kelvin Grove Campus, Victoria Park Road, Kelvin Grove, QLD 4059, Australia.

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Dr Neil Sipe

Address [6]

School of Environmental Planning, Nathan campus, Griffith University, Nathan, QLD 4111, Australia.

Country [6]

Australia

Other collaborator category [7]

Individual

Name [7]

Dr Angus (Shu Kay) Ng

Address [7]

School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.

Country [7]

Australia

Other collaborator category [8]

Individual

Name [8]

Professor Elizabeth Kendall

Address [8]

School of Human Services and Social work, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.

Country [8]

Australia

Other collaborator category [9]

Individual

Name [9]

Professor Ronan Lyons

Address [9]

Professor of Public Health, School of Medicine, Swansea University, Singleton Park, Swansea, SA2 8PP,Wales UK.

Country [9]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University HREC

Ethics committee address [1]

Office for Research
Nathan Campus
Bray Centre
Griffith University
170 Kessels Road
Nathan Qld 4111
AUSTRALIA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

11/07/2006

Ethics approval number [1]

MED/16/06/HREC

Ethics committee name [2]

Metro South Health Services District HREC

Ethics committee address [2]

Centres for Health Research
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba Qld 4102

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

04/10/2006

Ethics approval number [2]

HREC/06/QPAH/96

Ethics committee name [3]

Gold Coast Health Service District HREC

Ethics committee address [3]

Executive Offices
3rd Floor, Tower Block
Gold Coast Hospital
108 Nerang Street
Southport Qld 4215
AUSTRALIA

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

24/07/2006

Ethics approval number [3]

HREC/06/QGC/52

Ethics committee name [4]

North Coast Area Health Service HREC

Ethics committee address [4]

Po Box 126
Port Macquarie NSW 2444
AUSTRALIA

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

10/11/2006

Ethics approval number [4]

NCAHS HREC No 358N

Summary

Brief summary

The longitudinal birth cohort study Environments for Healthy Living (EFHL) is designed to collect information from before birth through to 25 years of age across a spectrum of eco-epidemiological factors, including but not limited to, genetic material from cord-blood samples at birth, individual and familial factors to spatial data on the living environment.  The EFHL study has had an annual four month recruitment of mothers since 2006.  Detailed information on each participant is obtained at birth, 12-months, 3 years, five years and at subsequent three to five yearly intervals. Data collected is centred on both mother and child and includes questions about nutrition, parenting style, psychological factors, child behaviour, physical activity, attachment behaviours, quality of life, illnesses and injuries, health outcomes, utilisation of health care services, and socioeconomic factors (e.g. income, education, family structure and cultural identity).  Findings will be used to identify where improvements can be made within the community to make health and lifestyle choices easier for families. The study will assist in discovering the best ways to reduce the major health problems facing Australians today, such as obesity, asthma, cardiovascular disease, cancer, diabetes, injury, mental health and musculoskeletal disorders.

Trial website

http://www.griffith.edu.au/health/school-medicine/research/population-health/environments-for-healthy-living

Trial related presentations / publications

Ng S, Olog A, Spinks A, Cameron CM, Searle J McClure RJ (2010) Risk factors and obstetric complications of large for gestational age births with adjustments for community effects: results from a new cohort study. BMC Public Health, 10:460.

Ng SK, Olog A, Spinks A, Cameron C, Searle J, McClure R (2009) Obstetric complications of large birth weight: The Environments for Healthy Living Study, Asia Conference on Emerging Issues in Public Health, Hong Kong, 29 Nov 29 – 2 Dec.

Spinks A, McClure R, Cameron C, Kisely S, Ng SK, Scuffham P, Scott R, Thwaites R, Lyons R, Sipe N (2009) Injury in the first year of life: results from an Australian birth cohort. Keeping Kids Safe from Injury, 2009 Safer Together Conference, Wollongong, NSW, Oct 29-30.

Spinks A, McClure R, Cameron C, Kisely S, Ng SK, Scuffham P, Scott R, Thwaites R, Lyons R, Sipe N (2009) Injury in the first year of life: results from an Australian birth cohort. 9th National Conference on Injury Prevention & Safety Promotion, Melbourne, July 26-28.

Spinks A, McClure R, Cameron C, Kisely S, Ng SK, Scuffham P, Scott R, Thwaites R, Lyons R, Sipe N (2008) Injury in the first year of life: results from an Australian birth cohort. 2nd Asia Pacific Injury Prevention Conference, Hanoi, Vietnam, Nov 4-6.

Ng S-K, Scott R, Scuffham PA. Contactable non-responders show different characteristics compared to lost to follow-up participants: Insights from an Australian longitudinal birth cohort study. Maternal and Child Health 2016; 20(7);1472-1484 

Ng S-K, Cameron CM, Hills AP, McClure RJ, Scuffham PA. Socioeconomic disparities in prepregnancy BMI and impact on maternal and neonatal outcomes and postpartum weight retention: the EFHL longitudinal birth cohort study.  BMC Pregnancy and Childbirth 2014; 14:314

Cameron CM, Scuffham PA, Shibl R, Ng S, Scott R, Spinks A, Mihala G, Wilson A, Kendall E, Sipe N, McClure RJ. Environments For Healthy Living (EFHL) Griffith birth cohort study: characteristics of sample and profile of antenatal exposures.  BMC Public Health 2012; 12(1):1080

Cameron CM, Scuffham PA, Spinks A, Scott R, Sipe N, Ng S, Wilson A, Searle J, Lyons RA, Kendall E, Halford K, Griffiths LR, Homel R, McClure RJ.  Environments for Healthy Living (EFHL) Griffith birth cohort study: background and methods.  Maternal and Child Health Journal 2012; 16(9):1896-1905

Public notes

Contacts

Principal investigator

Name

Prof Paul Scuffham

Address

School of Medicine, Logan campus, University Drive, Meadowbrook, Griffith University, QLD 4131, Australia.

Country

Australia

Phone

+61 7 33821367

Fax

p.scuffham@griffith.edu.au

Contact person for public queries

Name

Ms Rani Scott

Address

School of Medicine, Logan campus, Meadowbrook, Griffith University, QLD 4131, Australia.

Country

Australia

Phone

+61 7 33821374

Fax

+61 7 33821338

rani.scott@griffith.edu.au

Contact person for scientific queries

Name

Paul Scuffham

Address

School of Medicine, Logan campus, Meadowbrook, Griffith University, QLD 4131, Australia.

Country

Australia

Phone

+61 7 33821367

Fax

+61 7 33821338

p.scuffham@griffith.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?

Data dictionary
Individual survey data

When will data be available (start and end dates)?

2018 - 2025

Available to whom?

Researchers with a good question to address

Available for what types of analyses?

Any

How or where can data be obtained?

Use of PC at Griffith

What supporting documents are/will be available?

No Supporting Document Provided

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	Environments For Healthy Living (EFHL) Griffith birth cohort study: characteristics of sample and profile of antenatal exposures	2012	https://doi.org/10.1186/1471-2458-12-1080
Embase	Maternal pregravid body mass index and child hospital admissions in the first 5 years of life: results from an Australian birth cohort.	2014	https://dx.doi.org/10.1038/ijo.2014.148
Embase	The role of fathers in child feeding: perceived responsibility and predictors of participation.	2014	https://dx.doi.org/10.1111/cch.12088
Embase	Protocol for assessing maternal, environmental and epigenetic risk factors for dental caries in children.	2015	https://dx.doi.org/10.1186/s12903-015-0143-2
Embase	Child injury: Does home matter?.	2016	https://dx.doi.org/10.1016/j.socscimed.2016.02.017
Embase	The association between third trimester multivitamin/mineral supplements and gestational length in uncomplicated pregnancies.	2016	https://dx.doi.org/10.1016/j.wombi.2015.07.185
Dimensions AI	Recurrent episodes of injury in children: an Australian cohort study	2016	https://doi.org/10.1071/ah15193
Embase	Milk other than breast milk and the development of asthma in children 3 years of age. A birth cohort study (2006-2011).	2018	https://dx.doi.org/10.3390/nu10111798
Embase	Parental-reported allergic disorders and emergency department presentations for allergy in the first five years of life; a longitudinal birth cohort.	2018	https://dx.doi.org/10.1186/s12887-018-1148-1
Embase	Children's untreated decay is positively associated with past caries experience and with current salivary loads of mutans Streptococci; negatively with self-reported maternal iron supplements during pregnancy: a multifactorial analysis.	2019	https://dx.doi.org/10.1111/jphd.12301
Embase	Immunisation status of children presenting to the emergency department: Linkage of a longitudinal birth cohort with national immunisation data.	2019	https://dx.doi.org/10.1111/jpc.14288

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

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