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Trial registered on ANZCTR


Registration number
ACTRN12617000964314
Ethics application status
Approved
Date submitted
29/06/2017
Date registered
5/07/2017
Date last updated
5/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The ARCHER Study - understanding how puberty hormone change affects health, wellbeing and behaviour in Australian adolescents living in regional New South Wales
Scientific title
The Adolescent Rural Cohort study of Hormones, health, Education, environments and Relationships - The ARCHER Study
Secondary ID [1] 292308 0
NHMRC GNT1003312
Universal Trial Number (UTN)
Trial acronym
ARCHER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Puberty hormones 303848 0
Condition category
Condition code
Metabolic and Endocrine 303212 303212 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The ARCHER study is a six-year multidisciplinary longitudinal cohort study using a community sample of adolescents living in/around Dubbo and Orange in regional NSW.

The study hypothesis is that onset and/or tempo of the rise in puberty hormones (testosterone and oestradiol) play a significant role in adolescent health, wellbeing and behaviour. As such, the study measures three/six-monthly change in urinary testosterone and oestradiol (see below), annual change in serum testosterone and oestradiol, and relates these hormonal changes to annual measures of physical health, mental health, wellbeing, behaviour and cognition.

Data collection involves collection of a three-monthly first-morning urine sample during years 1-3 of the study, and a six-monthly first-morning urine sample during years 4-6 of the study (all urine samples collected at home), as well as baseline and annual study visits.
At the study visits, adolescents undergo physical examination, complete a battery of questionnaires related to physical and mental health, wellbeing, behaviour and a cognition test. Parents/guardians complete a battery of questionnaires seeking demographic and family information. At around the time of annual visits, adolescents also provide a fasting morning blood sample (completed at the local pathology centre in Orange or Dubbo). All biological samples are biobanked at -80 degrees for future analyses.

The study recruited adolescents and their parent/guardian over a 27-month period between June 2011 and August 2013. The last recruited participant reached the third year of follow-up in mid-2016. It is expected that the cohort will complete six years of follow-up by August 2019.
Intervention code [1] 298481 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302587 0
Change in first-morning urinary testosterone analysed via liquid chromatography mass spectrometry
Timepoint [1] 302587 0
Years 1 to 3: every three months
Years 4 to 6: every six months

N.B. Urine collection is stepped down to six-monthly collection after the third year of follow-up (the majority of participants will have gone through puberty by then), in order to reduce participant burden.

The primary outcome is the pattern of change in this hormone, thus there is no primary end point per se.
Primary outcome [2] 302635 0
Change in first-morning urinary oestradiol analysed via liquid chromatography mass spectrometry
Timepoint [2] 302635 0
Years 1 to 3: every three months
Years 4 to 6: every six months

N.B. Urine collection is stepped down to six-monthly collection after the third year of follow-up (the majority of participants will have gone through puberty by then), in order to reduce participant burden.

The primary outcome is the pattern of change in this hormone, thus there is no primary end point per se.
Secondary outcome [1] 336444 0
Change in fasting serum testosterone analysed via liquid chromatography mass spectrometry
Timepoint [1] 336444 0
Baseline and annually up to year 6 of the study
Secondary outcome [2] 336445 0
HEIGHT:

Measured height using a stadiometer
Timepoint [2] 336445 0
Baseline and annually up to year 6 of the study
Secondary outcome [3] 336446 0
ADOLESCENT MOOD:

Adolescent mood/depressive symptoms via the 13-item Short Moods and Feeling Questionnaire, and one SMS mood question involving a linear analogue self-assessment scale (i.e. 0 to 10)
Timepoint [3] 336446 0
Baseline and annually up to year 6 of the study
Secondary outcome [4] 336447 0
SLEEP:

1. Sleep patterns and habits via the Youth Self Report Questionnaire, Carskadon Questionnaire on sleep/wake patterns, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)
Timepoint [4] 336447 0
Baseline and annually up to year 6 of the study
Secondary outcome [5] 336448 0
Cognition and development of various aspects of brain function (including impulsivity, executive function, memory, attention) via WebNeuro - a web-based cognition testing platform
Timepoint [5] 336448 0
Annually from the 4th year of follow-up only (three time points to be collected in total)
Secondary outcome [6] 336449 0
SOCIO-DEMOGRAPHIC INFORMATION:

1. Parental education level, employment status and living situation

2. Neighbourhood socioeconomic status and access to services and amenities via geocoding

2. Family and local environment via the Macmaster’s Family Assessment Device
Timepoint [6] 336449 0
Baseline and annually up to year 6 of the study
Secondary outcome [7] 336461 0
HOSPITAL ADMISSIONS:

Hospital admissions via data linkage through the Centre for Health Record Linkage Master Linkage Key
Timepoint [7] 336461 0
No "time point" per se. We will extract this information relevant to the the 6 years of the study
Secondary outcome [8] 336582 0
Change in fasting serum oestradiol analysed via liquid chromatography mass spectrometry
Timepoint [8] 336582 0
Baseline and annually up to year 6 of the study
Secondary outcome [9] 336583 0
BODY COMPOSITION:

Body fat percentage, total fat mass and fat free mass via foot-to-foot bioelectrical impedance scales
Timepoint [9] 336583 0
Baseline and annually up to year 6 of the study
Secondary outcome [10] 336584 0
BLOOD PRESSURE:

Blood pressure via automated sphygmomanometer (output also includes heart rate)
Timepoint [10] 336584 0
Baseline and annually up to year 6 of the study
Secondary outcome [11] 336585 0
SELF-REPORTED PUBERTAL STATUS:

Self-reported Tanner stage via a questionnaire item involving standardised line drawings of the progressive
pubertal development stages
Timepoint [11] 336585 0
Baseline and annually up to year 6 of the study
Secondary outcome [12] 336586 0
BODY WEIGHT:

Measured weight using foot-to-foot bioelectrical impedance scales
Timepoint [12] 336586 0
Baseline and annually up to year 6 of the study
Secondary outcome [13] 336587 0
WAIST CIRCUMFERENCE:

Measured waist circumference using a tape measure and the smallest waist method
Timepoint [13] 336587 0
Baseline and annually up to year 6 of the study
Secondary outcome [14] 336588 0
FOOT LENGTH:

Measured length of the right foot using a foot ruler
Timepoint [14] 336588 0
Baseline and annually up to year 6 of the study
Secondary outcome [15] 336589 0
DEPRESSION/ANXIETY:

Depression/anxiety via the Youth Self Report Quesionnaire, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)
Timepoint [15] 336589 0
Baseline and annually up to year 6 of the study
Secondary outcome [16] 336590 0
SELF-HARM:

Self-harm via the 16-item Deliberate Self-Harm inventory (branched for those who scored highly on a related item in the Youth Self Report)
Timepoint [16] 336590 0
Baseline and annually up to year 6 of the study
Secondary outcome [17] 336591 0
SELF-COMPETENCY:

Self competency via selected questions taken from the Raine cohort study, the Cowen’s Self Efficacy Scale and Adolescent Self Perception Profile
Timepoint [17] 336591 0
Baseline and annually up to year 6 of the study
Secondary outcome [18] 336592 0
INTERNALISING / EXTERNALISING BEHAVIOUR:

Internalizing/externalizing score via the Youth Self-Report Questionnaire, and the Child Behaviour Check List Questionnaire (completed by parents/guardians)
Timepoint [18] 336592 0
Baseline and annually up to year 6 of the study
Secondary outcome [19] 336593 0
SCHOOL ENGAGEMENT:

Engagement in school and learning via the 12-item Motivation and Engagement Scale, and the Enjoyment of School, Academic Buoyancy and Class Participation scale
Timepoint [19] 336593 0
Baseline and annually up to year 6 of the study
Secondary outcome [20] 336594 0
UNINTENTIONAL INJURY:

Unintentional Injury in the preceding 12 months via the Youth Self Report Questionnaire, the 40-item Australian self-reported delinquency scale (branched for those who scored highly for externalising in the Youth Self Report), and the Child Behaviour Check List Questionnaire (completed by parents/guardians)
Timepoint [20] 336594 0
Baseline and annually up to year 6 of the study
Secondary outcome [21] 336595 0
SUBSTANCE USE:

Drug & alcohol use via selected questions taken from the Australian School Students Drug & Alcohol Survey
Timepoint [21] 336595 0
Baseline and annually up to year 6 of the study
Secondary outcome [22] 336596 0
SEXUALITY:

Encompassing romantic relationships, sexual feelings, history of STIs and pregnancy via questions taken from previous research by study investigators

N.B. this part of the questionnaire is branched to minimise exposure to such questions for those the questions are not relevant
Timepoint [22] 336596 0
Baseline and annually up to year 6 of the study
Secondary outcome [23] 336597 0
PHYSICAL ACTIVITY:

Physical activity, via selected questions taken from the Health Behaviour in School-Aged Children (HBSC) Study, and the NSW Schools Physical Activity and Nutrition Survey.
Timepoint [23] 336597 0
Baseline and annually up to year 6 of the study
Secondary outcome [24] 336598 0
NUTRITION:

Dietary intake via The Australian Child and Adolescent Eating Survey, selected questions taken from the NSW Schools Physical Activity and Nutrition Survey, and questions taken from previous research by study investigators
Timepoint [24] 336598 0
Baseline and annually up to year 6 of the study
Secondary outcome [25] 336599 0
TOBACCO USE:

Tobacco use via selected questions taken from the Health Behaviour in School-Aged Children (HBSC) Study.
Timepoint [25] 336599 0
Baseline and annually up to year 6 of the study
Secondary outcome [26] 336600 0
HOSPITAL EMERGENCY DEPARTMENT USAGE:

Emergency department attendance via data linkage through the Centre for Health Record Linkage Master Linkage Key
Timepoint [26] 336600 0
No "time point" per se. We will extract this information relevant to the the 6 years of the study
Secondary outcome [27] 336601 0
DEATH:

Death registration via data linkage through the Centre for Health Record Linkage Master Linkage Key
Timepoint [27] 336601 0
No "time point" per se. We will extract this information relevant to the the 6 years of the study

Eligibility
Key inclusion criteria
Healthy, normally developing adolescents living in the study recruitment catchment areas around Orange and Dubbo in regional NSW
Minimum age
10 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Adolescent intellectual disability
2. Lack of English competency in the adolescent
3. Lack of English competency in the parent/guardian

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The study is powered on the least common study outcome because there is inadequate existing data on which to power the study on its primary outcome of urinary puberty hormone change.

Depression is the least common outcome measured in the study, estimated to affect 5% of participants in mid- to late-puberty.

We estimated that 160 boys and 160 girls at Tanner Stage 3 (the pubertal stage where clinical onset of depression is most likely) will be required to detect a one SD difference in testosterone or oestradiol levels between those with and without depression. The anticipated loss to follow up was 5% per annum in this setting. Assuming a mean age of puberty onset of 11.4 years, 400 participants was set as the target for ensuring adequate numbers of adolescents reach Tanner Stage 3 during the study,

The main independent variables are age of onset at puberty and tempo of puberty. Both will be measured by testosterone and oestradiol, in blood and urine. Data analysis will have three main components:

1. The first component is testing the reliability and validity of measures under focus. These analyses will centre on:
a) descriptive, reliability and item functioning;
b) factor analysis to test factor structure and validity of measures;
c) ANOVAs for preliminary tests of main and interaction effects of background socio-demographics; and
d) tests of (in)variance in factor structure to ensure congruence in measurement properties across subgroups to justify pooling sample data for subsequent modeling throughout the project.

2. The second component is a correlational one and assesses the impact of tempo and onset of puberty over time. Specifically, for example, by assessing in the one analytic model (e.g. in linear regression models for continuous variables such as Youth Self Report scores for sensation seeking and in logistic regression models for dichotomous outcomes such as depression or sexual debut) the effects of Time 1 onset and tempo of puberty on Time 2 outcomes after controlling for Time 1 outcomes, it is possible to get a sense of the relative salience of the onset, and tempo of puberty in one time period over factors in a following time period. Also in these longitudinal analyses, key socio-demographic (and other) factors such as gender, school grade and socioeconomic factors can be included to get a further sense of puberty by controlling for other potential influences. The three monthly urine samples for the biological markers of puberty can be used to regress time on time measures, with tempo being defined by the residuals. Thus the larger and the more positive a residual over time, the more rapid the tempo of change.

3. The third component is based on mean-level differences (e.g. repeated measures) and explores for significant upward and downward shifts in means on target outcomes as a function of main effects (e.g. early and late onset; rapid and slow tempo) and interactions (e.g. early onset/rapid tempo; late onset/rapid tempo; early onset/slow tempo and late onset/slow tempo) of puberty effects that also control for key socio-demographic (and other) factors as covariates. Taken together, these analyses (and adaptations of them) allow for integrative tests of the substantive and methodological issues at hand.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/06/2011
Date of last participant enrolment
Anticipated
Actual
30/08/2013
Date of last data collection
Anticipated
30/08/2019
Actual
Sample size
Target
400
Accrual to date
Final
342
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 16538 0
2830 - Dubbo
Recruitment postcode(s) [2] 16539 0
2800 - Orange

Funding & Sponsors
Funding source category [1] 296850 0
Government body
Name [1] 296850 0
National Health and Medical Research Council
Country [1] 296850 0
Australia
Primary sponsor type
Individual
Name
Kate Steinbeck
Address
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 295851 0
Individual
Name [1] 295851 0
Catherine Hawke
Address [1] 295851 0
School of Rural Health
The University of Sydney
1502 Forest Road
Orange NSW 2800
Country [1] 295851 0
Australia
Secondary sponsor category [2] 295852 0
Individual
Name [2] 295852 0
Philip Hazell
Address [2] 295852 0
Rivendell
Thomas Walker Hospital
Hospital Rd
Concord West NSW 2138
Country [2] 295852 0
Australia
Secondary sponsor category [3] 295853 0
Individual
Name [3] 295853 0
Susan Rachel Skinner
Address [3] 295853 0
The Children's Hospital at Westmead Clinical School
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country [3] 295853 0
Australia
Secondary sponsor category [4] 295855 0
Individual
Name [4] 295855 0
Rebecca Ivers
Address [4] 295855 0
The George Institute for Global Health
Level 5, 1 King Street
Newtown NSW 2042 Australia
Country [4] 295855 0
Australia
Secondary sponsor category [5] 295856 0
Individual
Name [5] 295856 0
Robert Booy
Address [5] 295856 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country [5] 295856 0
Australia
Secondary sponsor category [6] 295857 0
Individual
Name [6] 295857 0
Robert Cumming
Address [6] 295857 0
Sydney School of Public Health
Edward Ford Building
The University of Sydney
NSW 2006 Australia
Country [6] 295857 0
Australia
Secondary sponsor category [7] 295858 0
Individual
Name [7] 295858 0
Gregory Fulcher
Address [7] 295858 0
Sydney Medical School - Northern
Kolling Building Level 7
Royal North Shore Hospital
Reserve Road
St Leonards NSW 2065
Country [7] 295858 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298079 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 298079 0
Ethics committee country [1] 298079 0
Australia
Date submitted for ethics approval [1] 298079 0
Approval date [1] 298079 0
13/09/2010
Ethics approval number [1] 298079 0
HREC 2012/2425 and HREC 2015/199

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75922 0
Prof Kate Steinbeck
Address 75922 0
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country 75922 0
Australia
Phone 75922 0
+61298452446
Fax 75922 0
Email 75922 0
[email protected]
Contact person for public queries
Name 75923 0
Karen Paxton
Address 75923 0
School of Rural Health
The University of Sydney
11 Moran Drive
Dubbo NSW 2830
Country 75923 0
Australia
Phone 75923 0
+61258099421
Fax 75923 0
Email 75923 0
[email protected]
Contact person for scientific queries
Name 75924 0
Kate Steinbeck
Address 75924 0
Academic Department of Adolescent Medicine
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Country 75924 0
Australia
Phone 75924 0
+61298452446
Fax 75924 0
Email 75924 0
[email protected]

No information has been provided regarding IPD availability


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
Plain language summaryNo To date we have published methodological data on n... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of growth, gonadal hormones, adiposity and the sodium-to-potassium ratio on longitudinal adolescent measures of blood pressure at puberty.2023https://dx.doi.org/10.1038/s41371-022-00774-x
N.B. These documents automatically identified may not have been verified by the study sponsor.