Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000763842
Ethics application status
Approved
Date submitted
30/04/2021
Date registered
18/06/2021
Date last updated
16/03/2023
Date data sharing statement initially provided
18/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Aussie Fans in Training (Aussie-FIT): a Footy-Themed Men’s Weight Loss and Physical Activity Program in Regional Australia
Scientific title
Aussie Fans in Training (Aussie-FIT): Regional Implementation of a Footy-Themed Weight Management and Health Behaviour Change Program for Men with Obesity
Secondary ID [1] 304103 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Obesity 321779 0
Overweight 322192 0
Condition category
Condition code
Diet and Nutrition 319508 319508 0 0
Obesity
Public Health 319509 319509 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BRIEF NAME: Regional Implementation of the Aussie-Fans in Training (Aussie-FIT) Program

WHY: Men are more likely to be living with overweight or obesity than women in Australia, but less likely to access interventions to help them manage their weight. 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 piloted in Australian Football League settings (ACTRN12617000515392). Aussie-FIT is informed by the literature on men’s preferences for weight management interventions, such as allowing autonomy over dietary intake, a physical activity component, and humour and social support. The program embeds behaviour change techniques (e.g., self-monitoring, goal setting and feedback on behaviours) and activities designed to facilitate psychological need satisfaction for autonomy, competence, and relatedness in relation to physical activity and eating behaviours. The gender-tailored Aussie-FIT program was appealing to men and demonstrated potential in supporting weight reduction and improving health behaviours in a pilot trial in Metropolitan areas (ACTRN12617000515392). However, Aussie-FIT, and other men’s behavioural weight management programs tend to recruit men from urban areas and higher socioeconomic circumstances.

WHAT:
Materials - Men participating will receive: a wrist worn physical activity monitor, an Aussie-FIT team shirt, and a participant workbook with educational content covered in the sessions. Coaches will receive a detailed program session delivery guide and various educational resources to support session deliveries. The Aussie-FIT participant workbook and coach session delivery guide have previously been used to deliver the Aussie-FIT program piloted in Perth (ACTRN12617000515392), with some minor adaptations made to the current version for delivery in regional contexts.

The participant workbook and coach session delivery guide were developed (and educational materials sourced), using resources available from: i) Football Fans in Training program, www.ffit.org.uk; Heart Foundation Australia, www.heartfoundation.org.au; LiveLighter® campaign, www.livelighter.com.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.

Procedures - Aussie-FIT is an Australian Football themed health promotion program for men aged 35-65 living with overweight or obesity. Participants attend group sessions which incorporate physical activity, and workshop style education. The education covers principles of healthy eating, behaviour change techniques and motivational principles. Each session covers a different topic (e.g., alcohol intake, food labels and goal setting). The physical activity components of sessions are not prescriptive and are tailored by the coaches to suit participants capabilities. Some examples include a group walk around the oval hand-passing the football around, aerobic circuit activities and small-sided AFL games.

WHO PROVIDES: Coaches will be recruited from the local community to facilitate the Aussie-FIT program deliveries in regional areas. Coaches will ideally be enthusiastic individuals that live locally, have a knowledge of Australian football, have some experience of a leadership role in a physical activity setting (e.g., coach, exercise instructor, teacher), good communication skills and the ability to help foster a supportive atmosphere with camaraderie between participants. Coaches will be trained by the research team in the core program content (physical activity and nutrition), and in the use of principles of motivation and behaviour change. Coach training will be approximately 15 hours of face-to-face delivery and will include opportunities to practice session deliveries and receive feedback from the research team and their peers. Coach training will be undertaken within the 2 months prior to coaches delivering the program for the first time.

HOW: The intervention will be delivered face-to-face with groups of approximately 15 men.

WHERE: The program will be delivered in venues with an indoor space for the educational component and an Australian football oval for the physical activity component of the sessions.

WHEN and HOW MUCH: Participants will attend twelve, weekly, 90-minute-long sessions. Aussie-FIT encourages a gradual increase in moderate to vigorous physical activity levels outside of the weekly sessions.

TAILORING: The program is not prescriptive in terms of activity and dietary changes the men make outside of the weekly sessions over the 12 weeks. Men are supported to make their own choices regarding changes to their diet and PA behaviours. Personalised feedback on the goals men set is provided from coaches on a week-by-week basis. Targeted areas for goal setting include portion control, reduction of sugary drinks and energy dense foods, reduction in alcohol consumption and a gradual increase in moderate physical activity (Rate of Perceived Exertion 4-5: raises heartbeat and makes you breathe a bit faster than normal, whilst still being able to talk).

HOW WELL:
Planned – Post-intervention coach interviews will explore barriers and facilitators to delivering the program with fidelity. Attendance at the program sessions will be monitored, but adherence to the self-directed components (e.g., physical activity goals) of the program will not be assessed.
Intervention code [1] 320431 0
Prevention
Intervention code [2] 320432 0
Behaviour
Intervention code [3] 320433 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327378 0
Assess program recruitment/reach 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 (i.e., socioeconomic demographics for representativeness and recruitment methods section).
Timepoint [1] 327378 0
This is a composite measure using information from study records collected between the recruitment period and session 1 of the program; and questionnaire data collected at baseline measures.
Primary outcome [2] 327379 0
Program engagement assessed via weekly attendance registers.
Timepoint [2] 327379 0
Participant attendance registered at each of the 12 weekly sessions.
Primary outcome [3] 327774 0
Program retention assessed via weekly attendance registers.
Timepoint [3] 327774 0
Assessed via participant attendance registers at the final two weekly sessions (session 11 and session 12) of the program.
Secondary outcome [1] 394858 0
Barriers and facilitators for coaches to deliver the Aussie-FIT program in regional towns. Assessed via post-program individual qualitative interviews with coaches.
Timepoint [1] 394858 0
Post-program individual coach interviews will both be completed within 8 weeks of program completion.
Secondary outcome [2] 394859 0
The extent to which the program is embraced by local coaches or organisations, what might need to be improved, and the potential for the program to run in regional towns in the future. Assessed via post-program individual qualitative interviews with coaches and post-program participant focus groups.

All feedback will be assessed as a composite secondary outcome.
Timepoint [2] 394859 0
This is a composite secondary outcome using information from post-program individual coach interviews and post-program focus groups which will both be held within 8 weeks of program completion.
Secondary outcome [3] 394860 0
Weight in kilograms measured with valid and reliable body scale (e.g. Tanita); light clothing, no shoes and empty pockets.
Timepoint [3] 394860 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [4] 394861 0
Self-reported diet outcomes 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. As used in Hunt et al 2014.
Timepoint [4] 394861 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [5] 394862 0
Positive and Negative Affect: Measured using the short form of the Positive and Negative Affect Scale (PANAS) (Thompson 2007).
Timepoint [5] 394862 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [6] 394863 0
Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor (Omron HEM-705CP, Milton Keynes, UK).
Timepoint [6] 394863 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [7] 394864 0
The total number of alcohol units consumed in previous week measured with a 7 day recall diary. Measured using the Dietary Instrument for Nutrition Education (DINE). As used in Hunt et al 2014.
Timepoint [7] 394864 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [8] 394865 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] 394865 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [9] 394866 0
Quality of life- The health related quality of life measured using the EQ-5D-5 L (Herdman et al 2011)
Timepoint [9] 394866 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [10] 394868 0
Self-esteem. Measured using the Rosenberg Self-Esteem (RSE) Scale (Rosenberg, 1965).
Timepoint [10] 394868 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [11] 394869 0
Need Support - The Interpersonal Behaviours Questionnaire (IBQ) (Rocchi et al 2017).
Timepoint [11] 394869 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [12] 394870 0
Automaticity subscale of the self-report habit index (Gardner et al 2012)
Timepoint [12] 394870 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [13] 394873 0
Participant level of moderate-to-vigorous physical activity measured using the International Physical Activity Questionnaire (IPAQ) (Lee et al 2011)
Timepoint [13] 394873 0
Measured at baseline and at the end of the 12 week intervention period.
Secondary outcome [14] 396544 0
This outcome is a primary study outcome.

Barriers and facilitators to recruitment of target population. Assessed via post-program individual qualitative interviews with coaches and program participant focus groups.

Timepoint [14] 396544 0
This is a composite measure using information from post-program individual coach interviews and post-program focus groups which will both be completed within 8 weeks of program completion.
Secondary outcome [15] 396545 0
This outcome is a primary study outcome.

Barriers and facilitators to program engagement of target population. Assessed via post-program individual qualitative interviews with coaches, post-program participant focus groups, post-program program evaluation surveys, and withdrawal survey.

Timepoint [15] 396545 0
This is a composite primary outcome. Post-program individual coach interviews and post-program focus groups will both be held within 8 weeks of program completion. Post-program program evaluation surveys will be completed after the 12 week program finishes. Short withdrawal surveys will be sent to participants upon withdrawal.
Secondary outcome [16] 396546 0
This outcome is a primary study outcome.

Barriers and facilitators to program retention of target population. Assessed via withdrawal surveys (upon study withdrawal).

Timepoint [16] 396546 0
A short withdrawal surveys will be completed upon participant withdrawal.
Secondary outcome [17] 396547 0
Participant level walking measured using the International Physical Activity Questionnaire (IPAQ) (Lee et al 2011)
Timepoint [17] 396547 0
Measured at baseline and at the end of the 12 week intervention period.

Eligibility
Key inclusion criteria
Men aged 35–65 years with an objectively measured BMI >28kg/m2.
Minimum age
35 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men who are unable to comprehend the information leaflet and consent documentation (despite verbal elaboration) to the extent that they are unable to provide informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data around recruitment/reach (e.g., N expressions of interest, N attending baseline measures, N eligible and invited to participate, what attracted men to the program and how they found out about the program), engagement (e.g., N sessions attended) and retention (N attending the penultimate or the final session) will be summarised using descriptive statistics. Participant baseline characteristics will be reported as means with standard deviations for continuous variables and numbers with percentages for categorical variables.

Post-program participant focus groups and individual coach interviews will be analysed separately. Reflexive Thematic Analysis of the qualitative interview data will be informed by the study outcomes, primarily focusing on the implementation of Aussie-FIT in regional towns.


Quantitative program outcomes measures (e.g., weight, dietary intake, psychological well-being) will be analysed using within group intention-to-treat methods and used to compare to the Aussie-FIT metropolitan pilot outcomes. Full information maximum likelihood estimation will be used to handle missing data to identify changes from baseline to post-program.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/06/2021
Actual
21/06/2021
Date of last participant enrolment
Anticipated
1/03/2022
Actual
15/03/2022
Date of last data collection
Anticipated
1/06/2022
Actual
24/06/2022
Sample size
Target
90
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 33830 0
6401 - Northam
Recruitment postcode(s) [2] 33831 0
6330 - Albany
Recruitment postcode(s) [3] 33832 0
6230 - Bunbury

Funding & Sponsors
Funding source category [1] 308487 0
Government body
Name [1] 308487 0
Department of Health
Country [1] 308487 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 309335 0
None
Name [1] 309335 0
Address [1] 309335 0
Country [1] 309335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308440 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 308440 0
Ethics committee country [1] 308440 0
Australia
Date submitted for ethics approval [1] 308440 0
05/03/2021
Approval date [1] 308440 0
03/05/2021
Ethics approval number [1] 308440 0

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

Contacts
Principal investigator
Name 110718 0
A/Prof Eleanor Quested
Address 110718 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 110718 0
Australia
Phone 110718 0
+61892665693
Fax 110718 0
Email 110718 0
[email protected]
Contact person for public queries
Name 110719 0
Matthew McDonald
Address 110719 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 110719 0
Australia
Phone 110719 0
+61481458730
Fax 110719 0
Email 110719 0
[email protected]
Contact person for scientific queries
Name 110720 0
Eleanor Quested
Address 110720 0
Curtin School of Population Health, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 110720 0
Australia
Phone 110720 0
+61892665693
Fax 110720 0
Email 110720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Following publication of results related to health outcomes and up to 5 years thereafter.
Available to whom?
Only researchers who provide a methodologically sound proposal, as judged by the PI.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



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.