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Trial registered on ANZCTR
Registration number
ACTRN12624001236583
Ethics application status
Approved
Date submitted
28/08/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Comparative analysis of Home-based vs. Laboratory-based High-Intensity Interval Training in Females with Polycystic Ovary Syndrome who are overweight/obese.
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Scientific title
Comparative analysis of Cardiometabolic, Reproductive and Mental Health Outcomes Following Home-based vs. Laboratory-based High-Intensity Interval Training in Females with Polycystic Ovary Syndrome who are overweight/obese.
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Secondary ID [1]
312458
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N/A
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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:
Polycystic Ovarian Syndrome
334312
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Cardiometabolic health
334313
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Mental Health
334314
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Cardiorespiratory Fitness
334400
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Immune response
334401
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Reproductive health
334402
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Condition category
Condition code
Metabolic and Endocrine
330967
330967
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0
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Other endocrine disorders
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Reproductive Health and Childbirth
331770
331770
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0
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Other reproductive health and childbirth disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study will investigate the effects of 12 weeks of high-intensity interval training (HIIT) on females with polycystic ovary syndrome (PCOS). Participants will be randomly assigned to one of two groups: Home-Based HIIT (H-HIIT, intervention) and Laboratory-Based HIIT (L-HIIT, comparator). The H-HIIT intervention will involve three weekly sessions, with two sessions consisting of 12 x 1-minute intervals at 90-100% of maximum heart rate (HRmax) and one session of 8 x 4-minute intervals at 90-95% HRmax, all followed by active recovery periods. These sessions will be conducted remotely via Zoom and will be supervised by an experienced member of the research team. Participants will be provided with a magnetic bike trainer to convert their regular bicycles into stationary bikes. Each session will include a warm-up, intervals, active recovery periods, and a cooldown period. A smartwatch with a heart rate sensor will be used to record and store data for each participant, with adherence tracked through session attendance and compliance assessed by exercise intensity data from the monitors.
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Intervention code [1]
329045
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Treatment: Other
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Comparator / control treatment
Participants in the Laboratory-Based HIIT (L-HIIT) group will undertake two weekly sessions, each comprising 12 x 1-minute intervals at 90-100% of their maximum heart rate (HRmax) with one-minute active recovery, as well as one session consisting of 8 x 4-minute intervals at 90-95% HRmax with 2-minute active recovery. These sessions will be conducted in a laboratory setting at Victoria University on a stationary cycle ergometer, and will be supervised by an experienced member of the research team. Each session will include a warm-up, intervals, active recovery periods, and a cooldown period. A smartwatch equipped with a heart rate sensor will be used to record and store data for each participant. Adherence will be monitored through session attendance, and compliance will be evaluated using the exercise intensity data collected from the monitors.
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Control group
Active
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Outcomes
Primary outcome [1]
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Cardiometabolic Health
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Assessment method [1]
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Cardiometabolic Health will be assessed as a composite of outcomes including glycaemic control, cardiorespiratory fitness and lipid profiles.
- Glycaemic control will be measured through continuous glucose monitoring (CGM) and blood glucose levels will be measured using the Oral Glucose Tolerance Test (OGTT).
- Cardiorespiratory Fitness will be measured using a maximal graded exercise test to determine VO2 peak. The test will involve cycling at increasing intensities until volitional exhaustion, with breath-by-breath, expired respiratory gases collected and analysed.
- Lipid Profiles, Fasting Blood Glucose, and Inflammation: Blood samples will be collected and analysed to measure these parameters, providing a comprehensive assessment of metabolic health.
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Timepoint [1]
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Baseline, post-completion of intervention program (12 weeks, primary timepoint), and at 3 and 6-months follow-up.
Additionally, the CGM will be used for 7-day monitoring periods at four distinct timepoints: Baseline, immediately after the 12-week intervention, and at the 3-month and 6-month follow-ups.
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Primary outcome [2]
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Reproductive Health
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Assessment method [2]
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Menstrual Diaries: Participants will maintain self-reported menstrual diaries throughout the study. These diaries will help classify menstrual cycles and track any changes over the course of the intervention.
Hormonal Profiles: Blood samples will be analysed for testosterone, 17-hydroxyprogesterone (17-OHP), dihydrotestosterone, luteinising hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG), androstenedione, oestradiol, progesterone, dehydroepiandrosterone sulfate (DHEAS), Anti-Mullerian hormone (AMH) prolactin and thyroid stimulating hormone (TSH).
This will be assessed as a composite outcome. The hormonal profiles and self-reported menstrual diaries will be combined to classify menstrual cyclicity and track changes over the intervention period.
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Timepoint [2]
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Baseline, post-completion of intervention program (12 weeks, primary timepoint), and at 3 and 6 months follow-up.
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Primary outcome [3]
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Psychological Health.
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Assessment method [3]
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This will be a composite psychological health outcome, with mental health assessed using the Depression Anxiety Stress Scales (DASS-21) and quality of life measured through the Survey Form-36 (SF-36) and Polycystic Ovary Syndrome Questionnaire (PCOSQ).
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Timepoint [3]
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Baseline, post-completion of intervention program (12 weeks, primary timepoint) and at 3 and 6 months follow up.
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Secondary outcome [1]
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Physical Activity
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Assessment method [1]
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To monitor physical activity accelerometer will be worn continuously for 24 hours a day over 7 days.
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Timepoint [1]
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The accelerometer will be worn continuously for 24 hours a day over a 7-day period at baseline, post-completion of intervention program (12 weeks), and during the 3-month and 6-month follow-ups.
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Secondary outcome [2]
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Barriers and Facilitators
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Assessment method [2]
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For assessing barriers and facilitators to exercise focus group discussions for both groups will be conducted in a quiet, private setting or remotely via Zoom based on participant preference. Each session will last 45 to 60 minutes, allowing flexibility for discussion. Topics will include barriers and facilitators to exercise, motivations, benefits, challenges, and suggestions for improvement. Digital recordings and notes by a second researcher will ensure data accuracy. After the discussion, audio-recorded focus group data will be transcribed and systematically analysed to understand the physiological and psychological effects of the exercise intervention by at least two researchers.
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Timepoint [2]
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Post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.
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Secondary outcome [3]
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Dietary Habits
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Assessment method [3]
438750
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Participants will be asked to log everything they eat and drink for seven consecutive days to create a record of their usual dietary habits.
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Timepoint [3]
438750
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Baseline, post-completion of intervention program (12 weeks) and at 3 and 6 months follow-up.
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Secondary outcome [4]
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Physical Health Assessment
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Assessment method [4]
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Body composition changes will be assessed using Dual X-ray Absorptiometry (DXA) scans, which provide detailed measurements of body fat percentage, lean muscle mass, and bone density. Additionally, height and weight will be measured to calculate Body Mass Index (BMI).
This will be evaluated as a composite outcome.
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Timepoint [4]
438980
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Baseline, post-completion of intervention program (12 weeks), and at 6-months follow-up.
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Eligibility
Key inclusion criteria
The inclusion criteria for the study require participants to be females aged between 18-45 years (pre-menopausal), diagnosed with Polycystic Ovary Syndrome (PCOS), insufficiently active (do not meet the minimum physical activity recommendations of 150 min of moderate to vigorous activity per week) and have a Body Mass Index (BMI) greater than 25 kg/m².
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The exclusion criteria include pregnancy or breastfeeding, smoking, diabetes, uncontrolled hypertension (greater than 160/100 mmHg), established cardiovascular disease (CVD), renal impairment, malignancy, or taking medications that interfere with the study endpoints (such as insulin sensitizers and anti-obesity drugs).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation concealment for this study will be implemented using central randomization by computer.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be done using a randomisation table created by computer software. Participants will be stratified by BMI and age and allocated to the intervention groups at a 1:1 ratio.
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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
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Data will be checked for normality using the Shapiro- wilk test and non-normally distributed variables will be log-transformed before analysis. Group comparisons [home-based HIIT vs. lab-based HIIT] will be made with independent samples t-tests for baseline characteristics. Outcomes will be assessed using linear mixed models or generalised linear mixed models to determine the effect of exercise mode (group) over time. Estimated marginal means will be calculated from the linear mixed models to examine the within-group changes. Thematic analysis will be done to analyse the interview data. Significance will be accepted when p < 0.05.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/11/2024
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Actual
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Date of last participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last data collection
Anticipated
30/01/2026
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
316873
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University
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Name [1]
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Victoria University
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Address [1]
316873
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Country [1]
316873
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Australia
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Primary sponsor type
University
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Name
Victoria University
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Address
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Country
Australia
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Secondary sponsor category [1]
319116
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None
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Name [1]
319116
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Address [1]
319116
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Country [1]
319116
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315633
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Victoria University Human Research Ethics Committee
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Ethics committee address [1]
315633
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https://www.vu.edu.au/researchers/research-lifecycle/conducting-research/human-research-ethics/vu-human-research-ethics-committee-vuhrec
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Ethics committee country [1]
315633
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Australia
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Date submitted for ethics approval [1]
315633
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23/05/2024
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Approval date [1]
315633
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12/08/2024
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Ethics approval number [1]
315633
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Summary
Brief summary
The primary purpose of this study is to compare the effects of home-based High-Intensity Interval Training (HIIT) with laboratory-based HIIT on the health of women with Polycystic Ovary Syndrome (PCOS) who are overweight or obese. The study will examine various health outcomes over a 12-week period, including cardiorespiratory fitness, body composition, and glycaemic control. The hypothesis is that home-based HIIT will be as effective as laboratory-based HIIT in improving these health outcomes. This study aims to provide a more accessible exercise option for women with PCOS, potentially offering a cost-effective and convenient way to manage their condition through home-based training. Participants will undergo baseline testing, engage in the HIIT program, and complete follow-up assessments to evaluate the long-term benefits post 12- week intervention. The study involves researchers from Victoria University, the University of Adelaide, and Monash University, ensuring a comprehensive approach to improving the quality of life for women with PCOS.
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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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Prof Andrew McAinch
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Address
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Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
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Country
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Australia
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Phone
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+61 3 9919 2019
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Fax
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Email
135326
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[email protected]
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Contact person for public queries
Name
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Naina Tyagi
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Address
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Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
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Country
135327
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Australia
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Phone
135327
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+61 478644570
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Fax
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Email
135327
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[email protected]
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Contact person for scientific queries
Name
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Andrew McAinch
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Address
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Victoria University - Footscray Park Campus 70/104 Ballarat Rd, Footscray VIC 3011
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Country
135328
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Australia
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Phone
135328
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+61 39919 2019
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Fax
135328
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Email
135328
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No, individual participant data (IPD) for this trial will not be available. This ensures the confidentiality and privacy of participants' personal information and data collected during the study.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24138
Informed consent form
388067-(Uploaded-08-08-2024-00-31-16)-Information to participant form.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.
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