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Trial registered on ANZCTR
Registration number
ACTRN12625000351415
Ethics application status
Approved
Date submitted
8/04/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
A therapeutic movement program for adolescents engaged in gender diversity services
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Scientific title
The Movement Program: Feasibility of a trans-specific exercise program for adolescent clients at gender diversity services
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Secondary ID [1]
314167
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
mental health
337007
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sedentary behaviour
337010
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well-being
337011
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eating disorders
337013
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gender dysphoria
337009
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neurodivergence
337008
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quality of life
337012
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disordered eating
337118
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Condition category
Condition code
Physical Medicine / Rehabilitation
333465
333465
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
- The "Movement Program" is a twelve-week exercise intervention for adolescents within the GENder identiTy Longitudinal Experience Cohort (GENTLE cohort; RGS0000000320).
- Frequency and mode of administration: one supervised group exercise session per week for 12 consecutive weeks. Groups of minimum 3, maximum 10 participants.
- Intensity: The program's activities are designed to be adaptable, with exercises that can be progressed and/or regressed to suit varying age groups and abilities, ensuring all participants are both engaged and appropriately challenged. Progression may include increased duration of activity, greater resistance, or more complex movements. Session intensity will be assessed via a Borg RPE at the end of each session. Overall session intensity will range from moderate to vigorous depending on participant presentations.
- Time: Each session will run for 60 minutes.
- Type of exercises prescribed: Each exercise session will include a variety of elements, described below, and can be tailored for individual differences, needs and abilities. A warm-up and check-in will be undertaken (e.g., adequate nutritional intake, any new injuries, mood check in) to prepare the participants for physical activity and allow for exercise modifications or limitations. Followed by cardiorespiratory fitness activities that elevate heart and breathing rates (e.g., running, dancing, or aerobic fitness games); muscular strength exercises targeting strength and endurance of various muscle groups, using free weight equipment or bodyweight (e.g., push-ups, squats, planks); sport skill development or games to assist team building and socialisation (e.g., soccer, pickleball, or floorball).
- Strategies to monitor adherence: session attendance checklists are completed at the end of each session by the exercise instructor in their clinical handover notes. Reason for absenteeism are also written down in the session checklist.
- Elements specifically tailored to trans adolescents include: The movement program will be held at local community recreational spaces, including indoor (e.g., halls) and outdoor spaces (e.g., ovals). These venues will be carefully set up to prioritise the safety and inclusive environment for trans adolescents. For example, creating a safe and inclusive space may include removing or covering mirrors, displaying LGBTQIA+ affirming signage, providing all-gender bathroom access, and offering orientation and inductions to help participants feel comfortable, familiarised and supported in the space.
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Intervention code [1]
330766
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Prevention
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Intervention code [2]
330765
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Rehabilitation
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Feasibility - This will be assessed as a composite outcome
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Assessment method [1]
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The primary feasibility outcomes are guided by type 2 effectiveness-implementation hybrid trials (Curran et al., 2012) and feasibility trial guidelines (Eldridge et al., 2016), incorporating both quantitative and qualitative methods. As per CONSORT guidelines for feasibility and pilot trials, key feasibility indicators will include recruitment and drop-out rates, session attendance and duration, program expectations, and adherence to exercise programming. The tools used to collect data to assess feasibility indicators include attendance session checklists, audits of study/session logs, participant end of session checklists ( e.g., Borg RPE scales, likert enjoyment and motivation to return scales), Feasibility outcomes will be collected from all participants (i.e., movement program participants, parents/carers and exercise instructors).
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Timepoint [1]
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Study level outcome (e.g., recruitment, reach, adherence) measures will be assessed upon conclusion of the study. For participant-level outcomes (e.g., intervention satisfaction, enjoyment, motivation) measures will be assessed at completion of the 12-week exercise program.
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Secondary outcome [1]
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Body Composition
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Assessment method [1]
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Dual-Energy X-ray Absorptiometry (DEXA)
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Timepoint [1]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [2]
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Muscular endurance strength
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Assessment method [2]
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Muscular endurance strength will be measured via the squats in 60 seconds test.
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Timepoint [2]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [3]
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Power
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Assessment method [3]
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The Standing Broad Jump Test
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Timepoint [3]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [4]
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Well-Being
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Assessment method [4]
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The World Health Organisation-Five Well-being Index (WHO-5)
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Timepoint [4]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [5]
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Cardiovascular health
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Assessment method [5]
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Cardiovascular health will be measured via resting blood pressure (i.e., using a Welch Allen sphygmomanometer) and heart rate (i.e., using a polar sensor heart rate monitor).
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Timepoint [5]
446341
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [6]
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Physical Activity Participation Levels
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Assessment method [6]
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The Simple Physical Activity Questionnaire (SIMPAQ)
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Timepoint [6]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [7]
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Muscular endurance strength
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Assessment method [7]
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Muscular endurance strength will be measured via the dynamometer plank hold (0.1sec) test.
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Timepoint [7]
446342
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [8]
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Flexibility
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Assessment method [8]
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The Sit and Reach Test
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Timepoint [8]
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [9]
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Quality of Life.
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Assessment method [9]
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The 12-Item Short Form Survey (SF-12)
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Timepoint [9]
445914
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [10]
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Balance
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Assessment method [10]
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The Star Excursion Balance Test (SEBT)
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Timepoint [10]
445918
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [11]
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Strength.
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Assessment method [11]
445920
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Isometric strength will be measured via the grip strength test using a Jamar digital handgrip dynamometer
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Timepoint [11]
445920
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [12]
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Cardiorespiratory Fitness
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Assessment method [12]
445919
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The YMCA three-minute step test
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Timepoint [12]
445919
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Secondary outcome [13]
446344
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Muscular endurance strength
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Assessment method [13]
446344
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Muscular endurance strength will be measured via the push ups in 60 seconds test.
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Timepoint [13]
446344
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Measures will be assessed at baseline (pre-intervention) and at the latest two weeks after completing the intervention.
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Eligibility
Key inclusion criteria
All intervention participants will be current patients who are engaged with the Child and Adolescent Health Service, Perth Children’s Hospital Gender Diversity Service and who have consented to be part of the GENTLE Cohort (Children and Adolescent Health Service Health Research Ethics Committee RGS0000000320).
Intervention participants must have a sufficient command of the English language to be able to consent/assent or have parent/carer consent to participation.
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Minimum age
12
Years
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Participants will be excluded if they are unable to safely participate in exercise based on pre-exercise screening (ESSA., 2022).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All quantitative data will be analysed using Microsoft Excel and IBM Statistical Package for the Social Sciences (SPSS) Statistics software. Descriptive statistics and Repeated Measures Analyses of Variance (ANOVAs) of pre-to-post-program differences will be conducted. The magnitude of change in health outcome variables (i.e., physical health, well-being, and quality of life) from baseline to the end of the program will be determined by calculating Cohen’s d effect sizes, along with correlations between the variables. It is noted that the sample size for this study is in keeping with a pilot study however, given the novelty and intent of the intervention, findings will provide valuable insight into the health outcomes, the most effective operation of the program, and inform design of future interventions and research in this field.
Interviews will be conducted by the research team, who have experience in qualitative research methodology, including interviewing vulnerable young people, families, and health professionals. Participants will guide the interview, with probing questions used for clarification and exploration (Galetta., 2012). At the end, participants can ask questions, offer additional information, and provide feedback. Pragmatic considerations (e.g., time and resource constraints) will guide data collection, and we aim to collect sufficient, appropriate information to address our research questions and construct a comprehensive story through our data. We will adopt an inductive reflexive thematic analysis approach (Braun & Clarke, 2022; Braun et al., 2016). A ‘critical friends’ approach will be employed, with co-authors providing feedback on meaning units, themes, and interpretations (Carlson., 2018). Collaborative processes may result in themes being merged, redefined, or recoded based on collective interpretation, ensuring rigor and quality in analysis (Smith & McGannon., 2018). Reflexive thematic analysis is a cyclical and iterative process (i.e., it is not sequential), and various stages of the analysis process will be repeated or returned to.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
26/02/2025
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Date of last participant enrolment
Anticipated
2/06/2025
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Actual
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Date of last data collection
Anticipated
28/11/2025
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Actual
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Sample size
Target
20
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Accrual to date
7
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
27732
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
43921
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
318680
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University
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Name [1]
318680
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The University of Western Australia
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Address [1]
318680
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Country [1]
318680
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Australia
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Funding source category [2]
318679
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Charities/Societies/Foundations
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Name [2]
318679
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Thriving in Motion
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Address [2]
318679
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Country [2]
318679
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Australia
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Funding source category [3]
318681
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Government body
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Name [3]
318681
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Department of Health and Aged Care - Medical Research Futures Fund
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Address [3]
318681
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Country [3]
318681
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Australia
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Funding source category [4]
318682
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Hospital
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Name [4]
318682
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Perth Children's Hospital
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Address [4]
318682
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Country [4]
318682
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Australia
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Primary sponsor type
University
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Name
The University of Western Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
321104
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None
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Name [1]
321104
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Address [1]
321104
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Country [1]
321104
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Other collaborator category [1]
283468
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Other
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Name [1]
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The Kids Research Institute Australia
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Address [1]
283468
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Country [1]
283468
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317293
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The University of Western Australia Human Research Ethics Committee
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Ethics committee address [1]
317293
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http://www.research.uwa.edu.au/staff/human-research/welcome-to-HREO
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Ethics committee country [1]
317293
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Australia
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Date submitted for ethics approval [1]
317293
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01/08/2024
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Approval date [1]
317293
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06/09/2024
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Ethics approval number [1]
317293
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2024/ET000882
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Ethics committee name [2]
317291
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [2]
317291
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [2]
317291
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Australia
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Date submitted for ethics approval [2]
317291
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16/05/2024
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Approval date [2]
317291
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05/07/2024
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Ethics approval number [2]
317291
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RGS0000006883
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Summary
Brief summary
Trans and gender diverse adolescents face heightened physical and mental health challenges, with elevated rates of depression, self-harm, and suicide attempts (Strauss et al., 2020). Potential risks to cardiometabolic health also exist due to gender affirming medical therapy and unhealthy behaviors (Spanos et al., 2020). Given the well acknowledged benefits of physical activity for physical and mental health (Biddle & Asare., 2011), exercise presents a novel but underexplored strategy to mitigate some of the adverse mental and physical health symptoms and contribute to improve overall health and wellbeing of trans adolescents (Storr et al., 2021). The WA Gender Diversity Service is an outpatient service located at Perth Children’s Hospital that provides adolescents with a multidisciplinary approach to the assessment, care, and management of gender diversity. Currently there are no exercise services part of standard care within the WA service, nor is exercise incorporated as standard care in any gender services across Australia. The "Movement Program" is a twelve-week exercise intervention for adolescents within the GENder identiTy Longitudinal Experience Cohort (GENTLE cohort; RGS320). In collaboration with stakeholders, we aim to create and assess an evidence-based exercise intervention for bettering health, physical activity, and well-being of trans adolescents. The study will enable us to understand the impact exercise can have on trans adolescents’ health and wellbeing and whether providing such support during key developmental stages will also support trans adolescents in developing healthy (or healthier) physical activity behaviours. We propose to deliver the program over 2025 and anticipate up to 20 GENTLE adolescents participating in the intervention. We aim to enhance service delivery and address a significant gap in international research by developing this project within the GENTLE Cohort. Our goal is to determine whether this evidence-based exercise service can complement the current health services of the WA Gender Diversity Service.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Felicity Austin
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Address
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The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
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Country
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Australia
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Phone
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+61 0400198166
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Fax
140590
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Email
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[email protected]
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Contact person for public queries
Name
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Felicity Austin
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Address
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The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
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Country
140591
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Australia
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Phone
140591
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+61 0400198166
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Fax
140591
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Email
140591
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[email protected]
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Contact person for scientific queries
Name
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Felicity Austin
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Address
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The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
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Country
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Australia
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Phone
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+61 0400198166
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Fax
140592
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Email
140592
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Informed consent form
Movement Program Participant PICF Version 2 24 June 2024.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF