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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]

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

Cardiovascular Health Risks

Physical Inactivity

Overweight

Obesity

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Other cardiovascular diseases

Public Health

Health promotion/education

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

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]

24-hour dietary recall assessed using the Intake24 self-report measure.

Timepoint [1]