Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000437662
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
1/05/2023
Date last updated
7/04/2024
Date data sharing statement initially provided
1/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Kicking Goals for Men’s Heart Health: A Multi-State/Territory Trial of the Aussie-FIT Program
Scientific title
Scale-up of the Australian Fans in Training (Aussie-FIT) men’s health behaviour change program: a randomised controlled hybrid effectiveness-implementation trial
Secondary ID [1] 309305 0
This trial is sponsored by the National Heart Foundation of Australia. The funding award number is 106534.
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is linked to the following prior smaller studies involving the Aussie-FIT intervention.

ACTRN12617000515392
ACTRN12620001260910
ACTRN12621000763842

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 329482 0
Cardiovascular Health Risks 329483 0
Physical Inactivity 329484 0
Overweight 329525 0
Obesity 329736 0
Condition category
Condition code
Cardiovascular 326422 326422 0 0
Coronary heart disease
Cardiovascular 326423 326423 0 0
Other cardiovascular diseases
Public Health 326425 326425 0 0
Health promotion/education
Diet and Nutrition 326426 326426 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Aussie-Fans in Training (Aussie-FIT)

WHY.

Undertaking sufficient physical activity and healthy eating are critical to prevent people with lived experience of or at-risk of cardiovascular disease (CVD) from experiencing future heart problems. However, most people with or at-risk of CVD fail to initiate or sustain these health behaviours long-term. This increases risks of future heart conditions and premature death. CVD is more common in men, but they are less likely than women to access interventions to help them manage their weight or improve their health behaviours. New strategies are required to increase adherence to physical activity and healthy eating amongst men with or at-risk of CVD.

Aussie-Fans in Training (Aussie-FIT) is based on an existing, successful, evidence-based program developed in Scotland (Football Fans in Training; FFIT). The original FFIT program was developed by a team of experts in obesity, physical activity, community-based programs, gender and health, and men’s weight management programs. FFIT was adapted for the Australian context and recently piloted in Australian Football League settings amongst men living with obesity (ACTRN12617000515392) and men with a history of CVD (ACTRN12620001260910) in Western Australian (WA) Football League settings, and in men living with obesity in Rugby League clubs (‘League-FIT’) in Queensland (QLD). Aussie-FIT is designed to directly (i.e., through engagement in need-promoting activities) and indirectly (i.e., via training of coaches who will deliver the programme in how to use a need supportive communication style) promote greater need fulfilment and in turn more autonomous motives to engage in physical activity and healthy eating practices.

WHAT.

Men participating will receive: a wrist worn physical activity monitor, a sports club team shirt, and a participant workbook with educational content about nutrition, physical activity, and health behaviour change (which is also covered in the face-to-face sessions). Coaches will receive a detailed intervention delivery guide and educational resources (e.g., wallet cards to assess food labels) to support delivery of the weekly sessions. Coaches will utilise sports equipment (e.g., AFL and rugby league balls) from their respective clubs.
The participant workbook and coach session delivery guides have previously been used in the Aussie-FIT pilot studies. The participant workbook and coach session delivery guide were developed (and educational materials sourced), adapted from resources available from: i) Football Fans in Training program, www.ffit.org.uk; Heart Foundation Australia, www.heartfoundation.org.au; Australian Government Department of Health, National Health and Medical Research Council, www.eatforhealth.gov.au; Alcohol Think Again, www.alcoholthinkagain.com.au; and Cancer Council WA, www.cancerwa.asn.au. Minor adaptations have been made to these resources to reflect the target population (men with or at-risk of CVD) and the primary outcome (physical activity) in this trial, and to incorporate consumer and stakeholder feedback in WA, QLD, and the Northern Territory (NT).

Procedures.

Participants will attend 12 group sessions at their club that incorporates physical activity, and workshop style education. The education involves practical activities and discussions to help men understand why and how to improve their diet (e.g., interpreting food labels, portion sizes, meal planning, eating out) and physical activity habits (e.g., understanding exercise intensities, safe strength training, decreasing sedentary time). Men will be encouraged to use behaviour change techniques (e.g., self-monitoring, goal setting, and problem solving) to help put the recommendations into practice. Participants take part in physical activity within the sessions that starts off slowly in the initial weeks and gradually builds up over the course of the program. Activities men participate in include ball skills and circuit training similar to that undertaken by Australian football and rugby league players but modified to be safe for each man’s abilities (e.g., ball skill drills restricted to walking). Participants are taught about different exercise intensities within the program and encouraged to self-monitor their exercise intensity (using a modified version of the Borg rating of perceived exertion). Men are encouraged to self-monitor walking, gradually increasing steps/day throughout the 12-weeks.

WHO PROVIDES.

Coaches will be recruited from ten sports clubs in Perth, Darwin, and Brisbane. Aussie-FIT coaches will be already embedded in their respective clubs, knowledgeable about Australian Football or Rugby League, and have experience of leading physical activity or sports coaching sessions. Coaches should have good communication skills and the ability to help foster a supportive atmosphere with camaraderie between participants. Accredited Exercise Physiologists (AEPs), or other suitably qualified/accredited health professionals will act as an assistant coach and co-facilitate program delivery. They will support the coach by undertaking any required health monitoring of participants (e.g., blood pressure checks), provide advice on safe exercise and provide first aid, if required. AEPs visually monitor and verbally check-in with participants in relation to their exercise intensity. Club coaches and AEPs will be trained by the research team in the core program content (physical activity, nutrition, motivation, behaviour change). The training is delivered face-to-face and comprises approximately 15 hours of interactive learning content and opportunities to practice session deliveries and receive feedback from the research team and peers.

HOW.

The intervention will be delivered face-to-face to groups of approximately 16 men.
Coaches are encouraged to utilise a communication style that supports psychological need satisfaction for autonomy, competence, and relatedness in relation to physical activity and eating behaviours.

WHERE.

The program will be delivered in Australian Football (WA and the NT) and rugby league (QLD) settings. This will include a suitable space for the educational program component (e.g., indoor clubroom) and access to the pitch/oval for physical activity. In some circumstances, outdoor spaces may be utilised to deliver the educational content and indoor spaces may be used for physical activity (e.g., if there is gym access, or in adverse weather conditions).

WHEN and HOW MUCH.

Participants will attend twelve, weekly, 90-minute sessions. Aussie-FIT encourages gradual increases in moderate to vigorous physical activity levels outside of the weekly sessions in daily life.

TAILORING.

The Aussie-FIT sessions and resources are informed by the best available evidence and population recommendations for age and CVD risk management (e.g., Australian guide to healthy eating, physical activity guidelines, and National Heart Foundation recommendations). The program is not prescriptive in terms of physical activity and dietary changes the men make outside of the weekly sessions. Men are supported to self-monitor their diet and physical activity behaviours, then make their own education-informed decisions on setting goals that are relevant to them. Health behaviour change goals that are self-determined are more likely to be sustainable. Personalised feedback on the goals men set is provided from coaches and peers in the weekly sessions throughout the program. Targeted behaviours for goal setting include portion size control, reduction of sugary drinks and energy dense foods, reduction in alcohol consumption, gradual increases in physical activity and reduced sedentary time.

Men participating in Aussie-FIT will have varying physical fitness levels and health conditions. Throughout the program AEPs and coaches will modify the physical activity within the sessions to suit men with differing physical capabilities. AEPs and coaches will be aware of pre-existing conditions and will interact with and observe participants during the program sessions, and tailor activities as required.

HOW WELL.

Attendance at the program sessions will be monitored by the coaches, but participant adherence to the self-directed components (e.g., physical activity goal setting) of the program will not be assessed. Fidelity of the program deliveries to key content (e.g., educational messages) and functions (e.g., appropriate use of behaviour change techniques) of the intervention that are outlined in the program delivery guide will be assessed via the analysis of a sub-sample of audio-recorded Aussie-FIT session deliveries across the study sites. Post-intervention coach interviews will explore any barriers and facilitators to delivering the program as intended.
Intervention code [1] 325740 0
Behaviour
Intervention code [2] 325741 0
Lifestyle
Intervention code [3] 325742 0
Prevention
Comparator / control treatment
Wait-list control group.

Participants randomised to the wait-list control arm will be invited to participate in Aussie-FIT after the 6-month assessment.

All participants will be directed to review standard guidelines (i.e., Heart Foundation online material) regarding physical activity and healthy eating after completion of the baseline assessments prior to randomisation.
Control group
Active

Outcomes
Primary outcome [1] 334266 0
Change in moderate-vigorous physical activity in minutes per day. Measured using an ActiGraph GTX-9 accelerometer. Participants will be asked to wear the monitor continuously for 1 week at each time-point, on their non-dominant wrist.
Timepoint [1] 334266 0
Measured at week 0 (baseline, pre-program), 3 months and 6 months (primary endpoint) following baseline. 12 months in the intervention group only.
Secondary outcome [1] 420055 0
24-hour dietary recall assessed using the Intake24 self-report measure.
Timepoint [1] 420055 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [2] 420056 0
Positive and Negative Affect: Measured using the short form of the Positive and Negative Affect Scale (PANAS).
Timepoint [2] 420056 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [3] 420057 0
Resting systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor (e.g., Omron HEM-705CP, Milton Keynes, UK)
Timepoint [3] 420057 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [4] 420058 0
Weight in kilograms measured with body weight scale (e.g., Seca); light clothing, no shoes and empty pockets.
Timepoint [4] 420058 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [5] 420059 0
BMI Calculated as weight in kilograms divided by the square of height in metres (kg/m2).

Weight is measured with body weight scale (e.g., Seca) and height is measured with a stadiometer (e.g., Seca).
Timepoint [5] 420059 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [6] 420060 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 [6] 420060 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [7] 420061 0
Quality of life - The health-related quality of life measured using the EQ-5D-5 L
Timepoint [7] 420061 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [8] 420062 0
Self-esteem. Measured using the Rosenberg Self-Esteem (RSE) Scale (Rosenberg, 1965).
Timepoint [8] 420062 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [9] 420063 0
Automaticity. The ‘Self-Report Behavioural Automaticity Index’
Timepoint [9] 420063 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [10] 420064 0
Goal conflict, facilitation. Goal conflict and facilitation scale.
Timepoint [10] 420064 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [11] 420065 0
Action and coping planning. Action planning and coping planning scale.
Timepoint [11] 420065 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [12] 420066 0
12-Item Version of the Behavioral Regulation in Exercise 3 (BREQ3) Questionnaire (Rocchi et al 2023).
Timepoint [12] 420066 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [13] 420067 0
Biological markers of CVD risk measured using an Accutrend Plus hand-held point of care device – Finger prick Blood specimen; Total cholesterol (Chol)
Timepoint [13] 420067 0
Measured at week 0 (baseline), 3 months and 6 months following baseline. 12 months in the intervention group only.
Secondary outcome [14] 420069 0
Program uptake/reach assessed via study records (i.e., recruitment activities undertaken, number of expressions of interest via website/phone/email, number attending baseline measures, number eligible at baseline, number attending the first session) and baseline self-report questionnaire data (e.g., socioeconomic demographics for representativeness and how participants found out about the program).

This is a composite measure.
Timepoint [14] 420069 0
Measured using data collected between the recruitment period and session 1 of the program; and questionnaire data collected at week 0 (baseline)
Secondary outcome [15] 420070 0
Adoption of Aussie-FIT.

This outcome will be assessed via study records, and will include the number of clubs/coaches that deliver the program, the total number of clubs/coaches expressing interest in delivering the program, the source of coaches (i.e., club employees/affiliation or outsourced) and the provision of adequate facilities/resources by clubs during intervention deliveries.
Timepoint [15] 420070 0
Measured across the lifespan of the project.
Secondary outcome [16] 420071 0
Program engagement will be assessed via weekly attendance registers.
Timepoint [16] 420071 0
Participant attendance registered at each of the 12 weekly sessions.
Secondary outcome [17] 420072 0
Fidelity of program delivery.

Fidelity to key content (e.g., educational messages) and functions (e.g., appropriate use of behaviour change techniques) via mixed methods, including coding of a subsample audio-recorded deliveries, and semi-structured individual coach interviews and participant focus group interviews with a member of the research team.

This is a composite measure.
Timepoint [17] 420072 0
Selected program sessions for session delivery coding, and coach/participant interviews at 6 months.
Secondary outcome [18] 420140 0
Program Implementation and Maintenance.

Views and experiences of barriers and facilitators to program delivery and to ongoing program implementation (e.g., adoption, sustainability, scale-up) by coaches, club administrators, and participants. Perceived satisfaction with proposed model of sustained program deliveries, intentions to continue delivering the program (clubs in this project) and intentions to initiate deliveries program when further funding secured (new clubs).

This is a composite measure.
Timepoint [18] 420140 0
Semi-structured individual qualitative interviews with coaches and participant focus groups with a member of the research team at 6 and 12m. Consumer and stakeholder group meetings and dissemination activities post-trial.

Secondary outcome [19] 420141 0
Individual participant maintenance of health behaviours and outcomes, and participants views and experiences of maintaining changes following the intervention via semi-structured participant focus groups with a member of the research team.

This is a composite measure.
Timepoint [19] 420141 0
Measures undertaken with intervention group participants at 6 and 12 months.

Eligibility
Key inclusion criteria
Participants must fit one of the following criteria. CVD diagnosis more than 3 months prior to commencing the study OR >10% risk of CVD, according to the criteria created by the Australian Chronic Disease Prevention Alliance and estimated via the online calculator (www.cvdcheck.org.au/calculator) OR body mass index > 28kg/m2.
Minimum age
35 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are being unable to comprehend information or consent documentation, diagnosed with CVD less than 3 months prior to the baseline assessments date and medical professional advises against participation.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed and will be undertaken via computerised central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants from each club (10 clubs, 32 participants per club) will be individually randomised (1:1 randomisation, in blocks of 8 to reduce prediction of group allocation). In each club, 16 men will commence the program immediately, and 16 men will commence the program in 6 months’ time. Randomisation will be completed by a researcher not involved in data collection.
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
We will recruit 320 men (160 per arm). This estimate is based on observed changes in moderate-to-vigorous PA (MVPA) in the Aussie-FIT pilot (Kwasnicka et al 2020) and provides 90% power to detect a difference of 11-minutes/day (standard deviation:27-minutes/day) of MVPA at 6-months (primary endpoint). We power on MVPA because PA reduces cardiovascular risk independently, as well as due to its effect on other risk factors (Mora et al 2007). A difference of 11-minutes/day is larger than the estimated minimum clinically important difference (5 to 6 minutes) required to reduce risk of cardiovascular disease in inactive adults (Rowlands et al 2021). We allow for a trial attrition rate of 20%. Aligned with the EuroFIT trial, we propose an individual randomisation, given the FFIT study confirmed that the minimal between-group contamination effects did not warrant higher sample size and costs of a cluster trial (Wyke et al 2019).

Post-intervention outcomes will be analysed with intention-to-treat and per-protocol approaches using linear mixed effect regression models. Potential confounders (e.g., age,
BMI, comorbidities) and baseline values of dependent variables will be entered as covariates.

As a measure of maintenance, within-group statistical analysis of all behavioural and health outcomes will be undertaken with intervention group participants at 12 months.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/07/2023
Actual
31/07/2023
Date of last participant enrolment
Anticipated
2/09/2024
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
320
Accrual to date
144
Final
Recruitment in Australia
Recruitment state(s)
NT,QLD,WA

Funding & Sponsors
Funding source category [1] 313498 0
Charities/Societies/Foundations
Name [1] 313498 0
National Heart Foundation of Australia
Country [1] 313498 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 315283 0
University
Name [1] 315283 0
Flinders University (NT)
Address [1] 315283 0
Flinders Rural and Remote Health NT - Darwin CDU Campus, Corner University Drive North and University Drive West, Casuarina NT 0909
Country [1] 315283 0
Australia
Secondary sponsor category [2] 315284 0
University
Name [2] 315284 0
Queensland University of Technology
Address [2] 315284 0
George St, Brisbane City QLD 4000
Country [2] 315284 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312687 0
South Metropolitan Health Services Human Research Ethics Committee
Ethics committee address [1] 312687 0
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH WA 6150
Ethics committee country [1] 312687 0
Australia
Date submitted for ethics approval [1] 312687 0
23/09/2022
Approval date [1] 312687 0
14/11/2022
Ethics approval number [1] 312687 0

Summary
Brief summary
Physical activity, healthy eating, and weight management are important to help prevent cardiovascular disease. Advancing on the success of pilot studies of the Australian Fans in Training (Aussie-FIT) program (ACTRN12617000515392 and ACTRN12620001260910),
this study will establish if Aussie-FIT can help men with or at risk of cardiovascular disease to improve and sustain improvements to their physical activity levels, diet, physical and psychological health, compared to men that have not undertaken the program. This study will also explore the potential for the Aussie-FIT program to continue to be delivered after this study finishes on a wider scale, to help more men to improve their cardiovascular health across Australia.

320 men aged 35-75 years old with or at-risk of cardiovascular disease will be recruited to take part in Aussie-FIT. Half of the men will commence the program immediately after their enrolment appointment and the other half will commence the program 6 months after their enrolment appointment. All participants will undertake measurement assessments at 3-months and 6-months. Participants starting the program immediately will also undertake a measurement assessment at 12 months. Aussie-FIT involves 12, weekly, face-to-face sessions including coach-led interactive education workshops and physical activity delivered in sports club settings (Australian Football in Perth and Darwin, and Rugby League in Brisbane). Findings from this study will inform a blueprint to support the sustainment and scale-up of Aussie-FIT across diverse Australian settings.

Trial website
www.aussiefit.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125562 0
A/Prof Eleanor Quested
Address 125562 0
Curtin University, Kent St, Bentley WA 6102
Country 125562 0
Australia
Phone 125562 0
+61 8 9266 5693
Fax 125562 0
Email 125562 0
eleanor.quested@curtin.edu.au
Contact person for public queries
Name 125563 0
Mr Matthew McDonald
Address 125563 0
Curtin University, Kent St, Bentley WA 6102
Country 125563 0
Australia
Phone 125563 0
+61481458730
Fax 125563 0
Email 125563 0
matthew.mcdonald1@curtin.edu.au
Contact person for scientific queries
Name 125564 0
A/Prof Eleanor Quested
Address 125564 0
Curtin University, Kent St, Bentley WA 6102
Country 125564 0
Australia
Phone 125564 0
+61 8 9266 5693
Fax 125564 0
Email 125564 0
eleanor.quested@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing agreements for individual participant data are being discussed by the trial team - this section will be amended accordingly upon conclusion of these discussions.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18710Study protocol    A protocol paper is being submitted to an open-acc... [More Details]
18711Statistical analysis plan    The statistical analysis plan will be made availab... [More Details]
18713Informed consent form    Informed consent will be made available on Open Sc... [More Details]



Results publications and other study-related documents

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