Trial Review

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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 information initially 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] 252919 0
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 258449 0
Child Injury 258450 0
Child Quality of Life 258451 0
Obesity 258452 0
Obstetric Complications and Birth weight 258453 0
Child Development 258454 0
Oral and Dental Health 258455 0
Health Care Utilisation 258458 0
Condition category
Condition code
Public Health 258617 258617 0 0
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] 257445 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259464 0
All Cause Morbidity
Timepoint [1] 259464 0
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] 266029 0
Child Injury
Timepoint [1] 266029 0
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] 266030 0
Child Quality of Life
Timepoint [2] 266030 0
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] 266031 0
Obesity
Timepoint [3] 266031 0
Child height and weight will be measured by anthropomorphic assessments at 5 years.
Secondary outcome [4] 266032 0
Obstetric Complications and Birth Weight
Timepoint [4] 266032 0
This will be assessed from perinantal data records following birth.
Secondary outcome [5] 266033 0
Child Development
Timepoint [5] 266033 0
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] 266034 0
Health Care Utilisation
Timepoint [6] 266034 0
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] 1049 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [2] 1050 0
Gold Coast Hospital - Southport
Recruitment hospital [3] 1051 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 3368 0
4131
Recruitment postcode(s) [2] 3369 0
4215
Recruitment postcode(s) [3] 3370 0
2485

Funding & Sponsors
Funding source category [1] 257887 0
University
Name [1] 257887 0
Griffith University
Country [1] 257887 0
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] 257086 0
None
Name [1] 257086 0
Address [1] 257086 0
Country [1] 257086 0
Other collaborator category [1] 251610 0
Individual
Name [1] 251610 0
Professor Paul Scuffham
Address [1] 251610 0
Centre for Applied Health Economics, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.
Country [1] 251610 0
Australia
Other collaborator category [2] 251611 0
Individual
Name [2] 251611 0
Professor Rod McClure
Address [2] 251611 0
Professor of Public Health Medicine, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.
Country [2] 251611 0
Australia
Other collaborator category [3] 251612 0
Individual
Name [3] 251612 0
Dr Cate Cameron
Address [3] 251612 0
NHMRC Research Fellow, School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.
Country [3] 251612 0
Australia
Other collaborator category [4] 251613 0
Individual
Name [4] 251613 0
Dr Anneliese Spinks
Address [4] 251613 0
CSIRO Sustainable Ecosystems, 306 Caromody Road, St Lucia, QLD 4067, Australia.
Country [4] 251613 0
Australia
Other collaborator category [5] 251614 0
Individual
Name [5] 251614 0
Professor Andrew Wilson
Address [5] 251614 0
Executive Dean, Faculty of Health, Queensland University of Technology, Kelvin Grove Campus, Victoria Park Road, Kelvin Grove, QLD 4059, Australia.
Country [5] 251614 0
Australia
Other collaborator category [6] 251615 0
Individual
Name [6] 251615 0
Dr Neil Sipe
Address [6] 251615 0
School of Environmental Planning, Nathan campus, Griffith University, Nathan, QLD 4111, Australia.
Country [6] 251615 0
Australia
Other collaborator category [7] 251616 0
Individual
Name [7] 251616 0
Dr Angus (Shu Kay) Ng
Address [7] 251616 0
School of Medicine, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.
Country [7] 251616 0
Australia
Other collaborator category [8] 251617 0
Individual
Name [8] 251617 0
Professor Elizabeth Kendall
Address [8] 251617 0
School of Human Services and Social work, Logan campus, Griffith University, Meadowbrook, QLD 4131, Australia.
Country [8] 251617 0
Australia
Other collaborator category [9] 251618 0
Individual
Name [9] 251618 0
Professor Ronan Lyons
Address [9] 251618 0
Professor of Public Health, School of Medicine, Swansea University, Singleton Park, Swansea, SA2 8PP,Wales UK.
Country [9] 251618 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259913 0
Griffith University HREC
Ethics committee address [1] 259913 0
Office for Research
Nathan Campus
Bray Centre
Griffith University
170 Kessels Road
Nathan Qld 4111
AUSTRALIA
Ethics committee country [1] 259913 0
Australia
Date submitted for ethics approval [1] 259913 0
Approval date [1] 259913 0
11/07/2006
Ethics approval number [1] 259913 0
MED/16/06/HREC
Ethics committee name [2] 259914 0
Metro South Health Services District HREC
Ethics committee address [2] 259914 0
Centres for Health Research
Princess Alexandra Hospital
199 Ipswich Road
Wooloongabba Qld 4102
Ethics committee country [2] 259914 0
Australia
Date submitted for ethics approval [2] 259914 0
Approval date [2] 259914 0
04/10/2006
Ethics approval number [2] 259914 0
HREC/06/QPAH/96
Ethics committee name [3] 259915 0
Gold Coast Health Service District HREC
Ethics committee address [3] 259915 0
Executive Offices
3rd Floor, Tower Block
Gold Coast Hospital
108 Nerang Street
Southport Qld 4215
AUSTRALIA
Ethics committee country [3] 259915 0
Australia
Date submitted for ethics approval [3] 259915 0
Approval date [3] 259915 0
24/07/2006
Ethics approval number [3] 259915 0
HREC/06/QGC/52
Ethics committee name [4] 259916 0
North Coast Area Health Service HREC
Ethics committee address [4] 259916 0
Po Box 126
Port Macquarie NSW 2444
AUSTRALIA
Ethics committee country [4] 259916 0
Australia
Date submitted for ethics approval [4] 259916 0
Approval date [4] 259916 0
10/11/2006
Ethics approval number [4] 259916 0
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 31807 0
Prof Paul Scuffham
Address 31807 0
School of Medicine, Logan campus, University Drive, Meadowbrook, Griffith University, QLD 4131, Australia.
Country 31807 0
Australia
Phone 31807 0
+61 7 33821367
Fax 31807 0
Email 31807 0
[email protected]
Contact person for public queries
Name 15054 0
Ms Ms Rani Scott
Address 15054 0
School of Medicine, Logan campus, Meadowbrook, Griffith University, QLD 4131, Australia.
Country 15054 0
Australia
Phone 15054 0
+61 7 33821374
Fax 15054 0
+61 7 33821338
Email 15054 0
[email protected]
Contact person for scientific queries
Name 5982 0
Prof Paul Scuffham
Address 5982 0
School of Medicine, Logan campus, Meadowbrook, Griffith University, QLD 4131, Australia.
Country 5982 0
Australia
Phone 5982 0
+61 7 33821367
Fax 5982 0
+61 7 33821338
Email 5982 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?
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Spinks AB, Cameron CM, Scuffham RA, Scott R, Ng SK... [More Details]
Study results articleYes Cameron CM, Davey TM, Kendall E, Wilson A, McClure... [More Details]
Study results articleYes Comans TA, Whitty JA, Hills AP, Kendall E, Turkstr... [More Details]
Study results articleYes Mervin MC, Byrnes J, Shibl R, Scuffham PA, Cameron... [More Details]
Study results articleYes Cameron CM, Shibl R, McClure RJ, Ng S-K, Hills AP ... [More Details]
Study results articleYes Scheltinga F, Shibl R, Green AC, Ng S-K, Scuffham ... [More Details]
Study results articleYes Golenko XA, Shibl R, Scuffham PA, Cameron CM (2015... [More Details]
Study results articleYes Davey TM, Cameron CM, Ng S-K, McClure RJ (2015) Th... [More Details]
Study results articleYes McAlpine JM, Scott R, Scuffham PA, Perkins AV, Van... [More Details]
Study results articleYes Osborne JM, Davey TM, Spinks AB, McClure RJ, Sipe ... [More Details]
Study results articleYes Osborne JM, Shibl R, Cameron CM, Kendrick D, Lyons... [More Details]
Study results articleYes Perkins AV, Vanderlelie JJ (2016) Multiple micronu... [More Details]
Study results articleYes Vanderlelie J, Scott R, Shibl R, Lewkowicz J, Perk... [More Details]
Study results articleYes Crilly J, Cameron CM, Scuffham PA, Good N, Scott R... [More Details]
Study results articleYes Keijzers G, Sweeny A, Crilly J, Good N, Cameron CM... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseParental-reported allergic disorders and emergency department presentations for allergy in the first five years of life; a longitudinal birth cohort.2018https://dx.doi.org/10.1186/s12887-018-1148-1
EmbaseMilk other than breast milk and the development of asthma in children 3 years of age. A birth cohort study (2006-2011).2018https://dx.doi.org/10.3390/nu10111798
EmbaseChild injury: Does home matter?.2016https://dx.doi.org/10.1016/j.socscimed.2016.02.017
EmbaseThe association between third trimester multivitamin/mineral supplements and gestational length in uncomplicated pregnancies.2016https://dx.doi.org/10.1016/j.wombi.2015.07.185
EmbaseMaternal pregravid body mass index and child hospital admissions in the first 5 years of life: results from an Australian birth cohort.2014https://dx.doi.org/10.1038/ijo.2014.148
EmbaseThe role of fathers in child feeding: perceived responsibility and predictors of participation.2014https://dx.doi.org/10.1111/cch.12088
EmbaseProtocol for assessing maternal, environmental and epigenetic risk factors for dental caries in children.2015https://dx.doi.org/10.1186/s12903-015-0143-2
EmbaseChildren'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.2019https://dx.doi.org/10.1111/jphd.12301
EmbaseImmunisation status of children presenting to the emergency department: Linkage of a longitudinal birth cohort with national immunisation data.2019https://dx.doi.org/10.1111/jpc.14288
Dimensions AIRecurrent episodes of injury in children: an Australian cohort study2016https://doi.org/10.1071/ah15193
Dimensions AIEnvironments For Healthy Living (EFHL) Griffith birth cohort study: characteristics of sample and profile of antenatal exposures2012https://doi.org/10.1186/1471-2458-12-1080
N.B. These documents automatically identified may not have been verified by the study sponsor.