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 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
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
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
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
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
Trial website
Trial related presentations / publications
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 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
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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
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
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
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
Dimensions AIRecurrent episodes of injury in children: an Australian cohort study2016https://doi.org/10.1071/ah15193
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
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
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
N.B. These documents automatically identified may not have been verified by the study sponsor.