Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000740291
Ethics application status
Approved
Date submitted
1/05/2018
Date registered
3/05/2018
Date last updated
3/05/2019
Date data sharing statement initially provided
3/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Active Breed pilot randomised controlled trial: a weight loss and lifestyle modification program for men in South-Western Sydney
Scientific title
The Active Breed pilot randomised-controlled trial: Feasibility and efficacy of a gender-tailored weight loss and lifestyle modification program for overweight men in South-Western Sydney
Secondary ID [1] 294761 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 307658 0
Physical Inactivity 307659 0
Dietary Intake 307660 0
Mental Health 307661 0
Domestic Violence 307672 0
Depression 307673 0
Anxiety 307674 0
Condition category
Condition code
Public Health 306723 306723 0 0
Health promotion/education
Diet and Nutrition 306725 306725 0 0
Obesity
Mental Health 306726 306726 0 0
Depression
Physical Medicine / Rehabilitation 306739 306739 0 0
Other physical medicine / rehabilitation
Mental Health 306740 306740 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active Breed is a 12-week men's health intervention targeting:
- weight loss through sustainable healthy lifestyle behaviours
- physical activity, including goal setting, strategies to increase physical activity and overcoming barriers
- nutrition, including increasing fruit and vegetable consumption, reducing saturated fat, salt, sugar and processed food intake
- mental health, including depression and anxiety and practical strategies to deal with stress
- violence prevention, including recognising signs of abuse and violence
The intervention will be tested as a two-armed randomised controlled trial, with a wait-list control group who will receive the intervention at a later date.

Group-based (face-to-face) sessions will be held once per week for 12 weeks at Belmore Sports Ground (Bulldogs' home stadium). Each weekly session will run for 90 minutes and will comprise an educational component (45-60 minutes) and a physical activity component (30-45 minutes). These sessions will be delivered by trained Active Breed facilitators, with support from content area experts including qualified exercise scientists and personal trainers (physical activity), mental health support services (representative from Beyond Blue for mental health), and domestic violence experts (representatives from White Ribbon Australia). Active Breed facilitators will have expertise in physical activity and exercise (e.g., qualified exercise scientists) and will attend a half day training course with two senior members of the research team (PhD qualified) with expertise in health promotion, physical education and men's health. During this session, facilitators will learn about engaging men, delivering gender-tailored information, building rapport with participants, and the content within the program. Senior members of the research team will be in attendance at all sessions, and facilitators will be involved in a debriefing session with the researcher/s after each session to identify strengths and areas for improvement.

One topic will be covered in each educational session, and these topics will be scheduled prior. The content delivery will vary in each session, and activities will include brief, interactive presentations and demonstrations (e.g., cooking class) and group discussion activities.

The weekly physical activity component of the sessions will include low to moderate intensity football skills and drills, small-sided touch football games, and supervised gym sessions. All physical activity sessions will be delivered by a qualified personal trainer and/or exercise scientist.

All participants will be provided with program resources including an Active Breed handbook (specifically developed for the program), generic information about health and health services (readily available, to be provided by external facilitators from external stakeholders), equipment pack (including a training shirt and drink bottle), and exclusive access to a participant website where program materials will be made available outside regular weekly sessions.

Participants will be encouraged to engage with the website at least weekly to support healthy lifestyle behaviours beyond the scope of the weekly sessions. Each intervention participant will receive a unique login allowing exclusive access to the website. We will explore the usability and engagement with the website in the process evaluation of the pilot study.

Adherence to the intervention will be monitored by attendance records at the weekly sessions. Interactions with the website will also be recorded (e.g., number of logins).
Intervention code [1] 301064 0
Lifestyle
Comparator / control treatment
Wait list control group will be offered the intervention after the 12 week (3 month) assessment period for intervention participants.
Control group
Active

Outcomes
Primary outcome [1] 305726 0
Weight - to be measured using calibrated electronic scales
Timepoint [1] 305726 0
Baseline, week 12 (end of intervention - primary end point), week 24 (follow-up, intervention only).
Secondary outcome [1] 346285 0
Light physical activity - total minutes and percentage of time, to be measured using ActiGraph GT3X accelerometers.
Timepoint [1] 346285 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [2] 346286 0
Dietary intake - measured using Food Frequency questionnaire
Timepoint [2] 346286 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [3] 346287 0
Body Mass Index (BMI) - to be calculated from participant height (measured using calibrated stadiometer) and weight (measured using calibrated electronic scales). BMI will be calculated as weight in kilograms divided by the square of height in meters.
Timepoint [3] 346287 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [4] 346294 0
Waist circumference - measured using a non-elastic tape measure at the midpoint between the lowest rib and the iliac crest
Timepoint [4] 346294 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [5] 346295 0
Blood pressure - measured using a digital upper-arm blood pressure monitor - three measurements to be taken and averaged for an accurate reading.
Timepoint [5] 346295 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [6] 346296 0
Symptoms of depression and anxiety - measured using the Kessler-10 psychological distress scale.
Timepoint [6] 346296 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [7] 346297 0
Health-related quality of life - measured using a signle item question: In general, how would you rate your heath-related quality of life?
Timepoint [7] 346297 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [8] 346298 0
Health literacy - measured using the Health Literacy Questionnaire
Timepoint [8] 346298 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [9] 346299 0
Masculinity - measured using the Male Role Norms Scale
Timepoint [9] 346299 0
Baseline, week 12 (end of intervention), week 24 (follow-up, intervention only).
Secondary outcome [10] 346301 0
Process evaluation - Participants will be asked to complete a process evaluation questionnaire to identity strengths and weaknesses, perceptions and suggestions related to the delivery of the intervention. The process evaluation questionnaire will be developed specifically for the study and will comprise questions related to specific elements of the intervention.
Timepoint [10] 346301 0
Week 12 (end of intervention only)
Secondary outcome [11] 346370 0
Moderate-to-vigorous physical activity - total minutes and percentage of time, assessed using ActiGraph GT3X accelerometers.
Timepoint [11] 346370 0
Baseline, 12 weeks (end of intervention) and 24 weeks (follow-up, intervention only).
Secondary outcome [12] 346371 0
Daily step counts - to be assessed using ActiGraph GT3x accelerometer.
Timepoint [12] 346371 0
Baseline, week 12 (end of intervention) and week 24 (follow-up, intervention only).

Eligibility
Key inclusion criteria
Men will be eligible to participate if they:
- Are aged between 35 and 64 years
- Have a BMI of 25-42 kg/m2
- Pass a pre-exercise screening questionnaire (or obtain a letter of clearance from their doctor if shown to be at high-risk of exercise-related contraindications).
- Can attend group-based sessions at Belmore Sports Ground
Minimum age
35 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men will not be eligible to participate if they:
- Do not pass the pre-exercise screening assessment (indicating they are at high risk of contraindications associated with physical activity)
- Cannot attend group-based sessions at Belmore Sports Ground

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)
Potential participants will be required to complete a pre-exercise screening assessment prior to participating in the study. Once cleared, participants will be randomly allocated to the intervention or wait-list control group.

The random allocation sequence will be generated by a statistician. Study information for the intervention and wait-list control groups will be placed into opaque envelopes and consecutively numbered according to the randomisation schedule. This process will be completed by a research assistant who is not involved in enrolment, assessment or allocation of participants.

Upon completion of baseline measurements, participants will meet with a research assistant (not involved in measurement) in a separate room to open the allocation envelope. The research assistant will explain the allocation based on the information contained in the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation allocation sequence will be generated by a statistician who will not have any contact with participants during the trial. The statistician will generate a randomisation table created by computer software (i.e. computerised sequence generation). The randomisation allocation sequence will be stored securely and concealed from research assistants involved in data collection, group allocation and data entry.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This pilot study will test the efficacy of the intervention and will provide baseline data for a power analysis for a larger-scale intervention.

Generalised linear mixed models will examine differences in primary and secondary outcomes between treatment groups. Qualitative data from the process evaluation will be analysed using hierarchical content analysis to generate meaning units, categories and themes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/05/2018
Actual
16/05/2018
Date of last participant enrolment
Anticipated
31/05/2018
Actual
31/05/2018
Date of last data collection
Anticipated
15/11/2018
Actual
13/12/2018
Sample size
Target
50
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299366 0
Commercial sector/Industry
Name [1] 299366 0
Canterbury League Club Ltd (via ClubsNSW)
Country [1] 299366 0
Australia
Funding source category [2] 299372 0
Commercial sector/Industry
Name [2] 299372 0
Canterbury Hurlstone Park RSL Club Ltd (via ClubsNSW)
Country [2] 299372 0
Australia
Funding source category [3] 299373 0
University
Name [3] 299373 0
Western Sydney University
Country [3] 299373 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 298652 0
None
Name [1] 298652 0
Address [1] 298652 0
Country [1] 298652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300271 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 300271 0
Ethics committee country [1] 300271 0
Australia
Date submitted for ethics approval [1] 300271 0
18/10/2016
Approval date [1] 300271 0
22/11/2016
Ethics approval number [1] 300271 0
H11914

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

Contacts
Principal investigator
Name 83106 0
Dr Emma George
Address 83106 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 83106 0
Australia
Phone 83106 0
+61247360052
Fax 83106 0
Email 83106 0
[email protected]
Contact person for public queries
Name 83107 0
Emma George
Address 83107 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 83107 0
Australia
Phone 83107 0
+61247360052
Fax 83107 0
Email 83107 0
[email protected]
Contact person for scientific queries
Name 83108 0
Emma George
Address 83108 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 83108 0
Australia
Phone 83108 0
+61247360052
Fax 83108 0
Email 83108 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
Ethics approval does not allow for sharing of individual level participant data.


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.