Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000515392
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
10/04/2017
Date last updated
13/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Aussie Fans in Training (Aussie-FIT): A weight loss program in sport settings
Scientific title
A gender-sensitised weight loss and healthy living programme for overweight and obese men delivered within Australian Football League clubs (Aussie-FIT): a feasibility and pilot randomised controlled trial
Secondary ID [1] 291375 0
Not applicable
Universal Trial Number (UTN)
Not applicable
Trial acronym
Aussie-FIT: Aussie Fans in Training
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Overweight 302372 0
Obesity 302373 0
Cardiovascular health risks 302374 0
Condition category
Condition code
Diet and Nutrition 301955 301955 0 0
Obesity
Public Health 301956 301956 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 overweight and physically inactive 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).
To help support the men to sustain PA changes, the program will include self-regulation strategies, such as a) helping the men understand how to respond appropriately to certain stimuli (e.g., triggers to being inactive and unhealthy eating); b) assisting them to set effective goals; c) teaching them strategies to avoid engaging in compensatory behaviours (e.g., being more sedentary or eating more following PA), and d) educating them in how to prevent relapse (i.e., returning to pre-intervention behaviours, which might result in weight gain).
The program will be delivered over 12 weekly, 90-minute sessions to groups of 15 men by coaches (i.e., tutor to participant ratio of 1:15). The sessions will include classroom based activities and coach-led PA sessions. Over the 12 weeks, the proportion of time dedicated to PA relative to classroom-based activities will increase, to align with the men’s increases in fitness. Activity monitors will be handed out in week one, when participants will be fully briefed in how to wear and use the devices. Participants will be asked to wear their activity monitor throughout the day and use it as a self-monitoring device.
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. Coaches will be given training in the Aussie-FIT delivery protocol. Coaches will receive two days of face-to-face training, followed by opportunities to practice session delivery and then receive feedback from the research team. Training topics will include PA, nutrition, and behaviour change strategies.
A multicomponent process evaluation (including interviews with fans, coaches, and coded audio recordings of coaches’ communication style in Aussie-FIT sessions) will be undertaken. Our evaluation will explore issues of: 1) implementation (i.e., the process of implementing the intervention such as when, where, and how the fans engaged in PA during and after the intervention period), 2) mediators of outcomes (e.g., motivation to engage in PA or healthy diet), and 3) potential moderators (e.g., age, socioeconomic status, baseline PA and dietary behaviours, baseline BMI). Fidelity of the delivery of Aussie-FIT by trained club community coaches will be examined via coding the content of the audio recordings of the program delivery sessions. We will determine whether the intervention delivery style and content were as intended by coding audio recordings. We will also measure the degree to which the behaviour change techniques have been taught appropriately by the coaches.
Intervention code [1] 297410 0
Lifestyle
Intervention code [2] 297411 0
Prevention
Intervention code [3] 297412 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] 301607 0
Viability of the recruitment procedures assessed from study recruitment database
Timepoint [1] 301607 0
Measured after recruitment closes (on target: yes/ no)
Primary outcome [2] 301608 0
Participants’ attrition assessed from attendance logs
Timepoint [2] 301608 0
Measured after 6 months post-intervention commencement (% of participants that completed final measures)
Primary outcome [3] 301670 0
Acceptability to participants and coaches assessed on by 5-point Likert-scale (that is a composite primary outcome)
Timepoint [3] 301670 0
Measured at 3 and 6 months post-intervention commencement
Secondary outcome [1] 333281 0
Weight in kilograms measured with valid and reliable body scale (e.g., Tanita)
Timepoint [1] 333281 0
Measured at 0 (baseline), 3 and 6 months
Secondary outcome [2] 333282 0
Height measured in centimetres with valid and reliable height measure
Timepoint [2] 333282 0
Measured at baseline
Secondary outcome [3] 333283 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; blinded assessor.
Timepoint [3] 333283 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [4] 333524 0
Systolic and diastolic blood pressure measured with valid and reliable blood pressure monitor
Timepoint [4] 333524 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [5] 333525 0
Self-reported diet 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.
Timepoint [5] 333525 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [6] 333528 0
Psychological well-being: Emotional states measured with valid and reliable the Positive and Negative Affect Schedule (PANAS questionnaire)
Timepoint [6] 333528 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [7] 333529 0
Psychological well-being: measured with valid and reliable the Self-esteem Scale
Timepoint [7] 333529 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [8] 333530 0
Motivation/reasons to engage in weight loss behaviours adapted from the treatment self-regulation questionnaire (TSRQ).
Timepoint [8] 333530 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [9] 333531 0
Economic evaluation measure measured with valid and reliable EQ-5DL
Timepoint [9] 333531 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement
Secondary outcome [10] 345526 0
Basic need satisfaction in relation to weight loss behaviours measured with the autonomy and competence sub-scales from the scale by Chen et al. (2015) and four items tapping relatedness satisfaction
Timepoint [10] 345526 0
Measured at 3 and 6 months post-intervention commencement.
Secondary outcome [11] 345527 0
The total number of alcohol units consumed in previous week measured with a 7 day recall diary.
Timepoint [11] 345527 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [12] 345528 0
Need support measured with valid and reliable Interpersonal Behaviours Questionnaire (IBQ).
Timepoint [12] 345528 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [13] 345529 0
Goal conflict and goal facilitation for PA measured with goal conflict and goal facilitation questionnaire designed specifically for this study. This is a composite secondary outcome.
Timepoint [13] 345529 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [14] 345530 0
Automaticity measured with the ‘Self-Report Behavioural Automaticity Index’ (SRBAI)
Timepoint [14] 345530 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [15] 345531 0
Sleep measured with valid and reliable Pittsburgh Sleep Questionnaire.
Timepoint [15] 345531 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [16] 345532 0
Planning and overcoming barriers to be physically active measured with action planning and coping planning questionnaire designed specifically for this study. This is a composite secondary outcome.
Timepoint [16] 345532 0
Measured at 0 (baseline), 3 and 6 months post-intervention commencement.
Secondary outcome [17] 345533 0
Demographics including age, ethnicity, education, marital status, current employment status, income, housing status measured with a questionnaire designed specifically for this study.
Timepoint [17] 345533 0
Measured at baseline.

Eligibility
Key inclusion criteria
Male participants, 35-65 years old, BMI 28 or higher, consent for randomisation.
Minimum age
35 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Being outside of the aforementioned age and BMI range; not identifying as male, unable to comprehend the information letter and consent documentation; and those who are already participating in a specific health promotion programme delivered at the club or elsewhere.

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 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
Recruiting
Date of first participant enrolment
Anticipated
7/05/2018
Actual
Date of last participant enrolment
Anticipated
29/06/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
120
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295848 0
Government body
Name [1] 295848 0
Healthway
Country [1] 295848 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University, Kent Street, Bentley, Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 294708 0
None
Name [1] 294708 0
Address [1] 294708 0
Country [1] 294708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297129 0
Curtin University Ethics Committee
Ethics committee address [1] 297129 0
Ethics committee country [1] 297129 0
Australia
Date submitted for ethics approval [1] 297129 0
30/03/2017
Approval date [1] 297129 0
22/05/2017
Ethics approval number [1] 297129 0

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

Contacts
Principal investigator
Name 73078 0
Dr Eleanor Quested
Address 73078 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 73078 0
Australia
Phone 73078 0
+61 9266 5693
Fax 73078 0
Email 73078 0
eleanor.quested@curtin.edu.au
Contact person for public queries
Name 73079 0
Dominika Kwasnicka
Address 73079 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 73079 0
Australia
Phone 73079 0
+61 8 9266 2559
Fax 73079 0
Email 73079 0
dominika.kwasnicka@curtin.edu.au
Contact person for scientific queries
Name 73080 0
Eleanor Quested
Address 73080 0
Health Psychology & Behavioural Medicine Research Group School of Psychology, Curtin University, GPO Box U1987 Perth, Western Australia, 6845
Country 73080 0
Australia
Phone 73080 0
+61 892665693
Fax 73080 0
Email 73080 0
eleanor.quested@curtin.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 372505-(Uploaded-27-03-2020-18-00-15)-Basic results summary.pdf
Plain language summaryNo The prevalence of overweight and obesity is higher... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a gender-sensitised weight loss and healthy living programme for overweight and obese men delivered in Australian football league settings (Aussie-FIT): A feasibility and pilot randomised controlled trial.2018https://dx.doi.org/10.1136/bmjopen-2018-022663
EmbaseThe Aussie-FIT process evaluation: feasibility and acceptability of a weight loss intervention for men, delivered in Australian Football League settings.2022https://dx.doi.org/10.1080/08870446.2021.1890730
N.B. These documents automatically identified may not have been verified by the study sponsor.