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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
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
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
Secondary ID [1] 301783 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 318253 0
Overweight 318254 0
Obesity 318255 0
Cardiovascular health risks 318257 0
Condition category
Condition code
Cardiovascular 316262 316262 0 0
Coronary heart disease
Cardiovascular 316263 316263 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 316264 316264 0 0
Hypertension
Cardiovascular 316265 316265 0 0
Other cardiovascular diseases
Diet and Nutrition 316266 316266 0 0
Obesity
Public Health 316267 316267 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 318081 0
Lifestyle
Intervention code [2] 318082 0
Treatment: Other
Intervention code [3] 318083 0
Behaviour
Comparator / control treatment
Comparator: waiting list comparison group; will receive the same intervention 3 months after baseline assessment
Control group
Active

Outcomes
Primary outcome [1] 324445 0
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.
Timepoint [1] 324445 0
Assessed throughout the program
Secondary outcome [1] 384679 0
24-hour dietary recall assessed using the Intake24 self-report measure.
Timepoint [1] 384679 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [2] 384694 0
Positive and Negative Affect: Measured using the short form of the Positive and Negative Affect Scale (PANAS).
Timepoint [2] 384694 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [3] 384695 0
The total number of alcohol units consumed in previous week measured with a 7 day recall diary.
Timepoint [3] 384695 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [4] 384697 0
Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor (Omron HEM-705CP, Milton Keynes, UK)
Timepoint [4] 384697 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [5] 384698 0
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.
Timepoint [5] 384698 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [6] 384699 0
Weight in kilograms measured with valid and reliable body scale (e.g. Tanita); light clothing, no shoes and empty pockets.
Timepoint [6] 384699 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [7] 386552 0
BMI Calculated as weight in kilograms divided by the square of height in metres (kg/m2).
Timepoint [7] 386552 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [8] 386554 0
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
Timepoint [8] 386554 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [9] 386557 0
Quality of life- The health related quality of life measured using the EQ-5D-5 L
Timepoint [9] 386557 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [10] 386561 0
Sleep- Measured using the Pittsburgh Sleep Questionnaire
Timepoint [10] 386561 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [11] 386563 0
Recruitment- How participants found out about the program; program uptake (number of people who expressed interest; number of people who fit inclusion criteria)
Timepoint [11] 386563 0
Measured at week 0 (baseline)
Secondary outcome [12] 386564 0
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
Timepoint [12] 386564 0
Measured at 3 and 6 months following baseline
Secondary outcome [13] 386565 0
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
Timepoint [13] 386565 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [14] 387791 0
Self-esteem. Measured using the Rosenberg Self-Esteem (RSE) Scale (Rosenberg, 1965).
Timepoint [14] 387791 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [15] 387793 0
Motivation to lose weight (Sheldon et al., 2017)
Timepoint [15] 387793 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [16] 388961 0
Biological markers of CVD risk- Blood specimen. Urea and electrolytes (UE)
Timepoint [16] 388961 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [17] 388962 0
Biological markers of CVD risk- Blood specimen; Liver function tests (LFT)
Timepoint [17] 388962 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [18] 388963 0
Biological markers of CVD risk- Blood specimen; C-reactive protein (CRP)
Timepoint [18] 388963 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [19] 388964 0
Biological markers of CVD risk- Blood specimen; Total cholesterol (Chol)
Timepoint [19] 388964 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [20] 388965 0
Biological markers of CVD risk- Blood specimen; Triglycerides (TG)
Timepoint [20] 388965 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [21] 388966 0
Biological markers of CVD risk- Blood specimen; Low density lipoprotein cholesterol (cLDL)
Timepoint [21] 388966 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [22] 388967 0
Biological markers of CVD risk- Blood specimen; High density lipoprotein (HDL)
Timepoint [22] 388967 0
Measured at week 0 (baseline), and 3 and 6 months following baseline
Secondary outcome [23] 388968 0
Biological markers of CVD risk- Blood specimen; Glycated haemoglobin (HbA1c)
Timepoint [23] 388968 0
Measured at week 0 (baseline), and 3 and 6 months following baseline

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed and it will be done by computerised central randomisation
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2020
Actual
1/02/2021
Date of last participant enrolment
Anticipated
1/03/2021
Actual
10/06/2021
Date of last data collection
Anticipated
31/12/2021
Actual
16/03/2022
Sample size
Target
72
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 17084 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 17434 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 30758 0
6150 - Murdoch
Recruitment postcode(s) [2] 31163 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 306215 0
Charities/Societies/Foundations
Name [1] 306215 0
National Heart Foundation of Australia
Country [1] 306215 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 306691 0
None
Name [1] 306691 0
Address [1] 306691 0
Country [1] 306691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306426 0
South Metropolitan Health Services Human Research Ethics Committee
Ethics committee address [1] 306426 0
Ethics committee country [1] 306426 0
Australia
Date submitted for ethics approval [1] 306426 0
27/10/2020
Approval date [1] 306426 0
15/01/2021
Ethics approval number [1] 306426 0
Ethics committee name [2] 306428 0
Curtin University Human Research Ethics Committee
Ethics committee address [2] 306428 0
Ethics committee country [2] 306428 0
Australia
Date submitted for ethics approval [2] 306428 0
09/11/2020
Approval date [2] 306428 0
25/01/2021
Ethics approval number [2] 306428 0

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

Contacts
Principal investigator
Name 103834 0
Dr Eleanor Quested
Address 103834 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 103834 0
Australia
Phone 103834 0
+61 08 9266 5693
Fax 103834 0
Email 103834 0
[email protected]
Contact person for public queries
Name 103835 0
Brendan Smith
Address 103835 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 103835 0
Australia
Phone 103835 0
+61 08 9266 2144
Fax 103835 0
Email 103835 0
[email protected]
Contact person for scientific queries
Name 103836 0
Dr Eleanor Quested
Address 103836 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 103836 0
Australia
Phone 103836 0
+61 08 9266 5693
Fax 103836 0
Email 103836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Awaiting ethical clearance


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8508Study protocol    To be made available on the Open Science Framework
8509Statistical analysis plan    To be made available on the Open Science Framework
8510Informed consent form    To be made available on the Open Science Framework
8511Clinical study report    To be made available on the Open Science Framework
8512Ethical approval    To be made available on the Open Science Framework
8513Analytic 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.