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Trial registered on ANZCTR
Registration number
ACTRN12620001260910
Ethics application status
Approved
Date submitted
24/07/2020
Date registered
24/11/2020
Date last updated
16/06/2022
Date data sharing statement initially provided
24/11/2020
Date results information initially provided
26/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Aussie Fans in Training (Aussie-FIT): Feasibility trial of a health improvement program for men with cardiovascular disease
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Scientific title
Can the Aussie-FIT healthy lifestyle intervention attract men with cardiovascular disease and improve their health? A pilot and feasibility study in the context of Australian football
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Secondary ID [1]
301783
0
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:
Cardiovascular Disease
318253
0
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Overweight
318254
0
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Obesity
318255
0
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Cardiovascular health risks
318257
0
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Condition category
Condition code
Cardiovascular
316262
316262
0
0
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Coronary heart disease
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Cardiovascular
316263
316263
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
316264
316264
0
0
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Hypertension
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Cardiovascular
316265
316265
0
0
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Other cardiovascular diseases
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Diet and Nutrition
316266
316266
0
0
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Obesity
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Public Health
316267
316267
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 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).
The target population for this intervention is designed for men with a history of Cardiovascular disease. Unlike previous Aussie-Fit and FFIT interventions, the educational process will place greater emphasis on increasing PA as behaviour change over weight loss.
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. 12, weekly, 90-minute sessions will be delivered to groups of ~18 men. Coaches will be trained by the research team in the core content (PA and diet education), and in the use of principles of motivation and behaviour change. Practical activities and discussions help men understand why and how to improve diet (e.g., interpreting food labels, portion sizes, meal planning, eating out) and PA habits (e.g., understanding exercise intensities, safe strength training, decreasing sedentary time), and incorporate behavior change techniques to put the recommendations into practice. PA activities will promote activity of a range of PA intensities, and ball skills and circuit training similar to that undertaken by AFL players, but modified to be safe for each man’s limitations (e.g., ball skill drills restricted to walking). Men are encouraged to self-monitor walking, gradually increasing steps/day throughout the 12-weeks.
Activity monitors will be handed out in week one (1), when participants will be fully briefed in how to wear and use the devices. Attendance records will be used to monitor adherence to the intervention.
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Intervention code [1]
318081
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Lifestyle
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Intervention code [2]
318082
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Treatment: Other
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Intervention code [3]
318083
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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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Assess trial feasibility with regard to participant uptake, adherence, and attrition from the study. Outcomes are assessed through records of expressions of interest, enrolments and completions, and registers of attendance at each session.
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Assessment method [1]
324445
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Timepoint [1]
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Assessed throughout the program
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Secondary outcome [1]
384679
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24-hour dietary recall assessed using the Intake24 self-report measure.
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Assessment method [1]
384679
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Timepoint [1]
384679
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [2]
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Positive and Negative Affect: Measured using the short form of the Positive and Negative Affect Scale (PANAS).
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Assessment method [2]
384694
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Timepoint [2]
384694
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [3]
384695
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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 [3]
384695
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Timepoint [3]
384695
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [4]
384697
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Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor (Omron HEM-705CP, Milton Keynes, UK)
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Assessment method [4]
384697
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Timepoint [4]
384697
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [5]
384698
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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.
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Assessment method [5]
384698
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Timepoint [5]
384698
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [6]
384699
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Weight in kilograms measured with valid and reliable body scale (e.g. Tanita); light clothing, no shoes and empty pockets.
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Assessment method [6]
384699
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Timepoint [6]
384699
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [7]
386552
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BMI Calculated as weight in kilograms divided by the square of height in metres (kg/m2).
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Assessment method [7]
386552
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Timepoint [7]
386552
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [8]
386554
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Waist circumference measured twice with a standard tape measure (three times, if the first two measurements differ by 5 mm or more) and the mean of all recorded measurements calculated
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Assessment method [8]
386554
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Timepoint [8]
386554
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [9]
386557
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Quality of life- The health related quality of life measured using the EQ-5D-5 L
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Assessment method [9]
386557
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Timepoint [9]
386557
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [10]
386561
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Sleep- Measured using the Pittsburgh Sleep Questionnaire
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Assessment method [10]
386561
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Timepoint [10]
386561
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [11]
386563
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Recruitment- How participants found out about the program; program uptake (number of people who expressed interest; number of people who fit inclusion criteria)
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Assessment method [11]
386563
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Timepoint [11]
386563
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Measured at week 0 (baseline)
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Secondary outcome [12]
386564
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Questionnaires and interviews adapted from Quested et al., (2018) will be used to evaluate the feasibility and acceptability of program- Attendance to program sessions and to measurement sessions; fidelity of program delivery; perceptions of effectiveness and acceptability (both coaches' and participants'). Interviews will be semi-structured with open-ended questions, audio-recorded and will last up to one hour
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Assessment method [12]
386564
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Timepoint [12]
386564
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Measured at 3 and 6 months following baseline
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Secondary outcome [13]
386565
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Questionnaires and interviews adapted from Quested et al., (2018) will be used to evaluate the coach training- Coaches will evaluate the training provided to them; and participants will feedback on the trainers' style. Interviews will be semi-structured with open-ended questions, audio-recorded and will last up to one hour
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Assessment method [13]
386565
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Timepoint [13]
386565
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [14]
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Self-esteem. Measured using the Rosenberg Self-Esteem (RSE) Scale (Rosenberg, 1965).
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Assessment method [14]
387791
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Timepoint [14]
387791
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [15]
387793
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Motivation to lose weight (Sheldon et al., 2017)
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Assessment method [15]
387793
0
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Timepoint [15]
387793
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [16]
388961
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Biological markers of CVD risk- Blood specimen. Urea and electrolytes (UE)
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Assessment method [16]
388961
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Timepoint [16]
388961
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [17]
388962
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Biological markers of CVD risk- Blood specimen; Liver function tests (LFT)
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Assessment method [17]
388962
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Timepoint [17]
388962
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [18]
388963
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Biological markers of CVD risk- Blood specimen; C-reactive protein (CRP)
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Assessment method [18]
388963
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Timepoint [18]
388963
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [19]
388964
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Biological markers of CVD risk- Blood specimen; Total cholesterol (Chol)
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Assessment method [19]
388964
0
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Timepoint [19]
388964
0
Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [20]
388965
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Biological markers of CVD risk- Blood specimen; Triglycerides (TG)
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Assessment method [20]
388965
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Timepoint [20]
388965
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [21]
388966
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Biological markers of CVD risk- Blood specimen; Low density lipoprotein cholesterol (cLDL)
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Assessment method [21]
388966
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Timepoint [21]
388966
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [22]
388967
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Biological markers of CVD risk- Blood specimen; High density lipoprotein (HDL)
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Assessment method [22]
388967
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Timepoint [22]
388967
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Secondary outcome [23]
388968
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Biological markers of CVD risk- Blood specimen; Glycated haemoglobin (HbA1c)
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Assessment method [23]
388968
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Timepoint [23]
388968
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Measured at week 0 (baseline), and 3 and 6 months following baseline
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Eligibility
Key inclusion criteria
Male participants aged 18 and over (no upper limit), BMI of 28 or over. CVD diagnosis at least 3 months prior to recruitment. No upper limit is placed on length of time since diagnosis. Consent for randomisation
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Unable to comprehend information or consent documentation
- Already participating in another exercise or healthy eating program
- Medical professional advises against participation
- Has had or is waiting for bariatric surgery within next 12 months
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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)
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
Completed
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Date of first participant enrolment
Anticipated
1/12/2020
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Actual
1/02/2021
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Date of last participant enrolment
Anticipated
1/03/2021
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Actual
10/06/2021
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Date of last data collection
Anticipated
31/12/2021
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Actual
16/03/2022
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Sample size
Target
72
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Accrual to date
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Final
52
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
17084
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [2]
17434
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
30758
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6150 - Murdoch
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Recruitment postcode(s) [2]
31163
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6000 - Perth
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Funding & Sponsors
Funding source category [1]
306215
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Charities/Societies/Foundations
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Name [1]
306215
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National Heart Foundation of Australia
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Address [1]
306215
0
334 Rokeby Road Subiaco
Perth WA 6008
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Country [1]
306215
0
Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
Kent Street, Bentley, Western Australia, 6102
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Country
Australia
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Secondary sponsor category [1]
306691
0
None
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Name [1]
306691
0
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Address [1]
306691
0
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Country [1]
306691
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306426
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South Metropolitan Health Services Human Research Ethics Committee
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Ethics committee address [1]
306426
0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH WA 6150
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Ethics committee country [1]
306426
0
Australia
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Date submitted for ethics approval [1]
306426
0
27/10/2020
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Approval date [1]
306426
0
15/01/2021
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Ethics approval number [1]
306426
0
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Ethics committee name [2]
306428
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Curtin University Human Research Ethics Committee
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Ethics committee address [2]
306428
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Human Research Ethics Committee, Curtin University
Kent Street, Bentley Western Australia, 6102
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Ethics committee country [2]
306428
0
Australia
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Date submitted for ethics approval [2]
306428
0
09/11/2020
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Approval date [2]
306428
0
25/01/2021
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Ethics approval number [2]
306428
0
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Summary
Brief summary
In this feasibility trial, we will create a version of Aussie-FIT, a men’s health program that uses the appeal of sport to engage men, adapted for cardiac patients’ needs. We aim to recruit 72 participants; 36 men will complete “Aussie-FIT” and 36 will receive “usual care”. The Aussie-FIT program will consist of workshops on healthy eating and building physical activity habits, and will offer a range of exercises, ball skills and circuit training. We will take pre- and post- assessments of weight, diet, physical activity, well-being and biomedical markers of cardiovascular risk. The project will provide pioneering evidence of the feasibility and acceptability of this program among cardiac populations and will set the stage for a future, fully powered trial to assess the potential role such programs to complement existing cardiac rehabilitation options.
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Trial website
www.aussiefit.org
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103834
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Dr Eleanor Quested
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Address
103834
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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
103834
0
Australia
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Phone
103834
0
+61 08 9266 5693
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Fax
103834
0
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Email
103834
0
[email protected]
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Contact person for public queries
Name
103835
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Mr Brendan Smith
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Address
103835
0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
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Country
103835
0
Australia
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Phone
103835
0
+61 08 9266 2144
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Fax
103835
0
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Email
103835
0
[email protected]
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Contact person for scientific queries
Name
103836
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Dr Dr Eleanor Quested
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Address
103836
0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
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Country
103836
0
Australia
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Phone
103836
0
+61 08 9266 5693
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Fax
103836
0
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Email
103836
0
[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
Awaiting ethical clearance
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
8508
Study protocol
To be made available on the Open Science Framework
8509
Statistical analysis plan
To be made available on the Open Science Framework
8510
Informed consent form
To be made available on the Open Science Framework
8511
Clinical study report
To be made available on the Open Science Framework
8512
Ethical approval
To be made available on the Open Science Framework
8513
Analytic code
To be made available on the Open Science Framework
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