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Trial registered on ANZCTR
Registration number
ACTRN12617000515392
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
10/04/2017
Date last updated
13/04/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Aussie Fans in Training (Aussie-FIT): A weight loss program in sport settings
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Scientific title
A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered within Australian Football League clubs (Aussie-FIT): a feasibility and pilot randomised controlled trial
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Secondary ID [1]
291375
0
Not applicable
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Universal Trial Number (UTN)
Not applicable
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Trial acronym
Aussie-FIT: Aussie Fans in Training
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Linked study record
Not applicable
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Health condition
Health condition(s) or problem(s) studied:
Overweight
302372
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Obesity
302373
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Cardiovascular health risks
302374
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Condition category
Condition code
Diet and Nutrition
301955
301955
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0
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Obesity
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Public Health
301956
301956
0
0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Aussie-FIT is a program designed to promote physical activity (PA), weight loss and healthy living among overweight and physically inactive middle-aged men in Australia, using the context of AFL. Aussie-FIT is based upon the existing, successful FFIT program (developed in Scotland). Aussie-FIT is tailored to engage males via delivery in the AFL context by coaches associated with the clubs, taking into account any salient cultural differences in the relationship between masculinity and health. The original FFIT program was developed by a team of experts in obesity, PA, community-based programs, gender and health, and delivery of men’s weight management programs. Aligned with the original FFIT, Aussie-FIT will be gender-sensitive and will aim to support participants to change their eating habits and food consumed (based on estimated weight maintenance requirements according to age, gender and body weight). The targeted strategies will include portion control, reduction of sugary drinks and energy dense foods, reduction in alcohol consumption, and a gradual increase in moderate PA that is initiated in the club setting but readily incorporated into daily lives to maximise sustainability of lifestyle changes (see Gray et al., 2013, for additional detail on intervention features and rationale).
To help support the men to sustain PA changes, the program will include self-regulation strategies, such as a) helping the men understand how to respond appropriately to certain stimuli (e.g., triggers to being inactive and unhealthy eating); b) assisting them to set effective goals; c) teaching them strategies to avoid engaging in compensatory behaviours (e.g., being more sedentary or eating more following PA), and d) educating them in how to prevent relapse (i.e., returning to pre-intervention behaviours, which might result in weight gain).
The program will be delivered over 12 weekly, 90-minute sessions to groups of 15 men by coaches (i.e., tutor to participant ratio of 1:15). The sessions will include classroom based activities and coach-led PA sessions. Over the 12 weeks, the proportion of time dedicated to PA relative to classroom-based activities will increase, to align with the men’s increases in fitness. Activity monitors will be handed out in week one, when participants will be fully briefed in how to wear and use the devices. Participants will be asked to wear their activity monitor throughout the day and use it as a self-monitoring device.
Four community coaches will be recruited to take the role of Aussie-FIT program tutors. The coaches will ideally be coaching personnel who usually deliver the clubs’ community programs and they will be selected on the basis of recommendations from our key contacts at each club, as well as their interest and enthusiasm for the role and relevant experience. Coaches will be given training in the Aussie-FIT delivery protocol. Coaches will receive two days of face-to-face training, followed by opportunities to practice session delivery and then receive feedback from the research team. Training topics will include PA, nutrition, and behaviour change strategies.
A multicomponent process evaluation (including interviews with fans, coaches, and coded audio recordings of coaches’ communication style in Aussie-FIT sessions) will be undertaken. Our evaluation will explore issues of: 1) implementation (i.e., the process of implementing the intervention such as when, where, and how the fans engaged in PA during and after the intervention period), 2) mediators of outcomes (e.g., motivation to engage in PA or healthy diet), and 3) potential moderators (e.g., age, socioeconomic status, baseline PA and dietary behaviours, baseline BMI). Fidelity of the delivery of Aussie-FIT by trained club community coaches will be examined via coding the content of the audio recordings of the program delivery sessions. We will determine whether the intervention delivery style and content were as intended by coding audio recordings. We will also measure the degree to which the behaviour change techniques have been taught appropriately by the coaches.
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Intervention code [1]
297410
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Lifestyle
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Intervention code [2]
297411
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Prevention
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Intervention code [3]
297412
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Behaviour
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Comparator / control treatment
Comparator: waiting list comparison group; will receive the same intervention 3 months after baseline assessment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Viability of the recruitment procedures assessed from study recruitment database
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Assessment method [1]
301607
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Timepoint [1]
301607
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Measured after recruitment closes (on target: yes/ no)
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Primary outcome [2]
301608
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Participants’ attrition assessed from attendance logs
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Assessment method [2]
301608
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Timepoint [2]
301608
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Measured after 6 months post-intervention commencement (% of participants that completed final measures)
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Primary outcome [3]
301670
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Acceptability to participants and coaches assessed on by 5-point Likert-scale (that is a composite primary outcome)
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Assessment method [3]
301670
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Timepoint [3]
301670
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Measured at 3 and 6 months post-intervention commencement
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Secondary outcome [1]
333281
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Weight in kilograms measured with valid and reliable body scale (e.g., Tanita)
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Assessment method [1]
333281
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Timepoint [1]
333281
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Measured at 0 (baseline), 3 and 6 months
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Secondary outcome [2]
333282
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Height measured in centimetres with valid and reliable height measure
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Assessment method [2]
333282
0
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Timepoint [2]
333282
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Measured at baseline
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Secondary outcome [3]
333283
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Physical activity measured with valid and reliable physical activity monitor ActiGraph GTX-9 worn continuously for 1 week at each time-point, on their waist; setup to gather continuous data at 30Hz epoch; blinded assessor.
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Assessment method [3]
333283
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Timepoint [3]
333283
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [4]
333524
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Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor
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Assessment method [4]
333524
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Timepoint [4]
333524
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [5]
333525
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Self-reported diet measured with valid and reliable adaptation of the Dietary Instrument for Nutrition Education (DINE) calculating a fatty food score, fruit and vegetable score, and sugary food score. High scores indicative of high consumption. Questionnaire items adjusted for Australian population.
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Assessment method [5]
333525
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Timepoint [5]
333525
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [6]
333528
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Psychological well-being: Emotional states measured with valid and reliable the Positive and Negative Affect Schedule (PANAS questionnaire)
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Assessment method [6]
333528
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Timepoint [6]
333528
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [7]
333529
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Psychological well-being: measured with valid and reliable the Self-esteem Scale
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Assessment method [7]
333529
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Timepoint [7]
333529
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [8]
333530
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Motivation/reasons to engage in weight loss behaviours adapted from the treatment self-regulation questionnaire (TSRQ).
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Assessment method [8]
333530
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Timepoint [8]
333530
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [9]
333531
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Economic evaluation measure measured with valid and reliable EQ-5DL
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Assessment method [9]
333531
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Timepoint [9]
333531
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement
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Secondary outcome [10]
345526
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Basic need satisfaction in relation to weight loss behaviours measured with the autonomy and competence sub-scales from the scale by Chen et al. (2015) and four items tapping relatedness satisfaction
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Assessment method [10]
345526
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Timepoint [10]
345526
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Measured at 3 and 6 months post-intervention commencement.
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Secondary outcome [11]
345527
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The total number of alcohol units consumed in previous week measured with a 7 day recall diary.
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Assessment method [11]
345527
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Timepoint [11]
345527
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [12]
345528
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Need support measured with valid and reliable Interpersonal Behaviours Questionnaire (IBQ).
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Assessment method [12]
345528
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Timepoint [12]
345528
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [13]
345529
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Goal conflict and goal facilitation for PA measured with goal conflict and goal facilitation questionnaire designed specifically for this study. This is a composite secondary outcome.
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Assessment method [13]
345529
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Timepoint [13]
345529
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [14]
345530
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Automaticity measured with the ‘Self-Report Behavioural Automaticity Index’ (SRBAI)
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Assessment method [14]
345530
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Timepoint [14]
345530
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [15]
345531
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Sleep measured with valid and reliable Pittsburgh Sleep Questionnaire.
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Assessment method [15]
345531
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Timepoint [15]
345531
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [16]
345532
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Planning and overcoming barriers to be physically active measured with action planning and coping planning questionnaire designed specifically for this study. This is a composite secondary outcome.
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Assessment method [16]
345532
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Timepoint [16]
345532
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Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
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Secondary outcome [17]
345533
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Demographics including age, ethnicity, education, marital status, current employment status, income, housing status measured with a questionnaire designed specifically for this study.
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Assessment method [17]
345533
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Timepoint [17]
345533
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Measured at baseline.
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Eligibility
Key inclusion criteria
Male participants, 35-65 years old, BMI 28 or higher, consent for randomisation.
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Minimum age
35
Years
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Maximum age
65
Years
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
Being outside of the aforementioned age and BMI range; not identifying as male, unable to comprehend the information letter and consent documentation; and those who are already participating in a specific health promotion programme delivered at the club or elsewhere.
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Study design
Purpose of the study
Prevention
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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)
Allocation is concealed and it will be done by computerised central randomisation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order generation: simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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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
Efficacy
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Statistical methods / analysis
Trial feasibility will be reported using descriptive statistics and percentages. Mixed linear modelling will also be employed to examine changes across and between groups in all measures over time, adjusting for clustering effects. Qualitative data will be analysed to explore acceptability and feasibility as well as implementation of the Aussie-FIT intervention using a combination of inductive and deductive thematic content analyses.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
7/05/2018
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Actual
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Date of last participant enrolment
Anticipated
29/06/2018
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Actual
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Date of last data collection
Anticipated
31/01/2019
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Actual
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Sample size
Target
120
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
295848
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Government body
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Name [1]
295848
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Healthway
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Address [1]
295848
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24 Outram Street, West Perth, Western Australia, 6005
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Country [1]
295848
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
Curtin University, Kent Street, Bentley, Western Australia, 6102
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Country
Australia
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Secondary sponsor category [1]
294708
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None
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Name [1]
294708
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Address [1]
294708
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Country [1]
294708
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297129
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Curtin University Ethics Committee
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Ethics committee address [1]
297129
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Human Research Ethics Committee, Curtin University Kent Street, Bentley Western Australia, 6102
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Ethics committee country [1]
297129
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Australia
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Date submitted for ethics approval [1]
297129
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30/03/2017
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Approval date [1]
297129
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22/05/2017
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Ethics approval number [1]
297129
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Summary
Brief summary
Overweight and obesity represent major health problems facing middle-aged men in Australia. In WA, four out of five men risk the quality and length of their lives by being overweight or obese. Middle-aged men are less likely than women to recognise that they are overweight or obese, less likely to know about the links between diet and health, and appear reluctant to participate in weight loss programs. This may be because such programs are typically marketed toward women and are often considered ‘female territory’. A new project led by researchers at Curtin University and Glasgow University offers a promising solution to the problem of how to engage men in weight loss and physical activity programs in WA. Building on the highly successful ‘Football Fans in Training’ (FFIT) program delivered in premier league soccer clubs in Scotland, a new, adapted, Aussie version (Aussie-FIT) will capitalise on men’s passion for AFL as a ‘hook’ to engage them in a physical activity and weight loss program based on sound scientific evidence. The research team will recruit 120 overweight and obese AFL fans to join a 12- week program which will be delivered at the ground of their favourite WA AFL team. The program will be delivered by club coaches trained by the project’s researchers. The men will be put through their paces on the hallowed turf of their favourite team and in the classroom, discuss important issues such as healthy eating and cutting back on drinking. A key part of the program is to educate and support the men to make sustainable changes that will improve their physical activity, eating and drinking habits for the better, and for the long term. The researchers will take a range of measures before and after the program, including physical activity levels, diet, mental health and weight, to assess the program’s effectiveness. When delivered in Scotland, FFIT was highly popular with middle-aged males from all walks of life, and very successful in helping them lose weight. In the future, the Aussie-FIT team aim to customise this program for other sports and groups of fans (e.g., females, families).
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Trial website
www.aussiefit.org
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Trial related presentations / publications
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Public notes
Not applicable.
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Contacts
Principal investigator
Name
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Dr Eleanor Quested
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Address
73078
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Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
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Country
73078
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Australia
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Phone
73078
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+61 9266 5693
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Fax
73078
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Email
73078
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[email protected]
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Contact person for public queries
Name
73079
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Dominika Kwasnicka
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Address
73079
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Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
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Country
73079
0
Australia
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Phone
73079
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+61 8 9266 2559
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Fax
73079
0
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Email
73079
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[email protected]
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Contact person for scientific queries
Name
73080
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Eleanor Quested
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Address
73080
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Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
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Country
73080
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Australia
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Phone
73080
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+61 892665693
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Fax
73080
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Email
73080
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[email protected]
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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
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
372505-(Uploaded-27-03-2020-18-00-15)-Basic results summary.pdf
Plain language summary
No
The prevalence of overweight and obesity is higher...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Protocol for a gender-sensitised weight loss and healthy living programme for overweight and obese men delivered in Australian football league settings (Aussie-FIT): A feasibility and pilot randomised controlled trial.
2018
https://dx.doi.org/10.1136/bmjopen-2018-022663
Embase
The Aussie-FIT process evaluation: feasibility and acceptability of a weight loss intervention for men, delivered in Australian Football League settings.
2022
https://dx.doi.org/10.1080/08870446.2021.1890730
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF