Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000266965
Ethics application status
Approved
Date submitted
10/02/2020
Date registered
28/02/2020
Date last updated
28/02/2020
Date data sharing statement initially provided
28/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot gender-sensitised lifestyle intervention for overweight men targeted at physical activity, diet, and mental health
Scientific title
A pilot gender-sensitised lifestyle intervention for overweight men targeted at physical activity, diet, and mental health
Secondary ID [1] 300371 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/Obesity 315989 0
Mental Well-being 316064 0
Condition category
Condition code
Public Health 314264 314264 0 0
Health promotion/education
Diet and Nutrition 314335 314335 0 0
Obesity
Mental Health 314336 314336 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Men in the intervention group with receive the 12-week HAT TRICK Aus program. HAT TRICK Aus is a group-based face-to-face intervention focused on physical activity, healthy eating, and mental fitness. This theory-guided program has been developed for men living in Australia using a participatory design process.

Weekly session will be collaboratively delivered by a health promotion specialist who has experience delivering lifestyle interventions for men and an accredited exercise professional (e.g., ESSA AES). Sessions will be held at Moore Park Precinct, Sydney, Australia, and utilise the affiliated training facilities/classroom space and surrounding parklands.

Following randomisation, all men in the intervention group will receive:
a) Weekly 90-minute session including targeted health education regarding physical activity, healthy eating, mental health, and behaviour change techniques (i.e., goal setting, self-monitoring). Each weekly session also includes a progressive physical activity program (i.e., increasing in duration and intensity on a weekly basis), initially beginning with 15 minutes in week 1 (mild to moderate intensity - 8-10 on the Borg RPE scale) and progressing to 60 minutes by week 12 (moderate to vigorous intensity - 12-15 on the Borg RPE scale). Exercises will include both aerobic (e.g., brisk walking) and resistance training (e.g., compound body weight movements), delivered using fun and engaging activities (e.g., walking soccer match).
b) Weekly challenges focused on encouraging participants to incorporate what they have learned during the weekly sessions into their daily lives.
c) The HAT TRICK Playbook: A print-based informational resource booklet with tailored messaging concerning physical activity, healthy eating and mental health. The Playbook has been specifically adapted* for this study through consultation with men living in Australia and is designed to be culturally relevant and gender-tailored. For example, the Playbook uses strength-based messaging, incorporates sport-themed references to frame health-related topics, and emphasises strategies that appeal to masculinities (e.g., independence, self-reliance, and mastery).
*Original source: Caperchione, C.M., Bottorff, J.L., Oliffe, J.L., Johnson, S.T., Hunt, K., Sharp, P., Pointer, C., Dudley, L., Fitzpatrick, K. (2018). HAT TRICK: Physical activity, healthy eating, and mental fitness playbook for men (Second Edition). University of British Columbia, Kelowna, BC.
d) Headgear (Black Dog Institute): A publicly available and free App focused on preventative mental health. The App has been previously tested among Australian men and utilises two therapies (behavioural activation and mindfulness) which have been shown to be effective in the treatment and prevention of common mental disorders.

Program adherence will be assessed using attendance records and participants' self-reported usage of the intervention components (e.g., Playbook). Participants who miss two or more consecutive sessions will be contacted by facilitators and reasons for absences/dropout will be recorded.
Intervention code [1] 316654 0
Lifestyle
Intervention code [2] 316709 0
Behaviour
Intervention code [3] 316710 0
Treatment: Other
Comparator / control treatment
The wait-list control group will not receive the HAT TRICK intervention until after they have completed the 12-week assessment. Wait-list participants will be asked to maintain their current lifestyle.
Control group
Active

Outcomes
Primary outcome [1] 322653 0
Physical activity, measured using the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Timepoint [1] 322653 0
Baseline and 12 week follow-up (post-intervention)
Primary outcome [2] 322792 0
Dietary quality, measured using a Dietary Quality Index (12-item).
Timepoint [2] 322792 0
Baseline and 12 week follow-up (post-intervention)
Primary outcome [3] 322793 0
Depression risk, measured using the Male Depression Risk Scale (MDRS-22)
Timepoint [3] 322793 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [1] 379189 0
Depressive Symptoms, measured using the 9-item Patient Health Questionnaire (PHQ-8).
Timepoint [1] 379189 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [2] 379807 0
Psychological well-being, measured using the World Health Organization (WHO) 5 item Well-being Index
Timepoint [2] 379807 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [3] 379808 0
Weight (kg) measured in light clothing, without shoes on a digital scale.
Timepoint [3] 379808 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [4] 379809 0
Blood pressure, measured using a portable automated blood pressure device (Omron 907, Omron Healthcare)
Timepoint [4] 379809 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [5] 379810 0
Waist Circumference, measured level with the umbilicus using a non-extensible steel tape
Timepoint [5] 379810 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [6] 379811 0
Anxiety symptoms, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7)
Timepoint [6] 379811 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [7] 379812 0
Social isolation, measured using the UCLA Loneliness Scale (3-item)
Timepoint [7] 379812 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [8] 379813 0
Body composition, inclusive of fat mass, fat free mass, and visceral adipose tissue, measured using a dual energy x-ray absorptiometry (DEXA) scan (Lunar Prodigy, GE Medical, Milwaukee, USA)
Timepoint [8] 379813 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [9] 379814 0
Functional fitness capacity, measured using the 6 minute walk test (6MWT)
Timepoint [9] 379814 0
Baseline and 12 week follow-up (post-intervention)
Secondary outcome [10] 379815 0
Muscular strength, measured using a mechanical grip strength dynamometer
Timepoint [10] 379815 0
Baseline and 12 week follow-up (post-intervention)

Eligibility
Key inclusion criteria
-Male
-Aged 28 to 64 years
-Overweight or obese (Body Mass Index >25kg/m2)
-Physical inactivity (engage in <150 minutes of physical activity per week)
-Poor diet (Not meeting recommended fruit and vegetable intake based on age/sex recommendations)
-Available to attend assessments and weekly sessions at Moore Park Precinct
Minimum age
28 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
-Currently participating (or plan to participate) in an alternative healthy lifestyle program or study
-Contraindications to exercise as identified by the PAR-Q+ tool that have not been cleared by a medical professional
- Unable to speak, read or understand English

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)
Participants will be randomised at an individual level by an independent statistician who will not have any contact with participants during the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be stratified by baseline BMI and Age ensuring equal distribution between groups. The allocation sequence within strata will be generated by a computer-based random number-producing algorithm in randomly varied block lengths. Randomisation codes will be stored in a restricted computer folder, which will not be accessible by those assessing participants, those involved in allocating participants to groups or those participating in data entry for the study. Complete separation will be achieved between the statistician who generated the randomisation sequence and those who conceal allocation from those involved in implementation of group assignments.
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
As a pilot study, we ran our power analysis using the largest effect size of the three primary outcomes (physical activity). Assuming 20% loss-to-follow-up, we intend to randomise 90 men to obtain follow-up measurements for 72 men (n=36 for each group). This sample size will provide 84% statistical power to detect a medium to large mean difference in the primary outcomes of 0.7 standard deviations between groups at post-test follow-up (a=0.05).

Intention to treat, linear repeated mixed models will be used to examine the intervention effect on all continuous study outcomes compared with the wait-list control, adjusted for significant covariates. These models will assess all outcomes for the impact of group (intervention vs. control), time (categorical) and the group-by-time interaction.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/02/2020
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
15/10/2020
Actual
Sample size
Target
90
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304796 0
University
Name [1] 304796 0
University of Technology Sydney
Country [1] 304796 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
Country
Australia
Secondary sponsor category [1] 305404 0
None
Name [1] 305404 0
Address [1] 305404 0
Country [1] 305404 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305211 0
UTS Human Research Ethics Committee
Ethics committee address [1] 305211 0
Ethics committee country [1] 305211 0
Australia
Date submitted for ethics approval [1] 305211 0
02/12/2019
Approval date [1] 305211 0
16/01/2020
Ethics approval number [1] 305211 0
ETH19-4234

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

Contacts
Principal investigator
Name 99622 0
Mr Paul Sharp
Address 99622 0
Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
PO Box 123. Broadway NSW 2007 Australia
Country 99622 0
Australia
Phone 99622 0
+61 29514 5210
Fax 99622 0
Email 99622 0
[email protected]
Contact person for public queries
Name 99623 0
Elizabeth Marin
Address 99623 0
Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
PO Box 123. Broadway NSW 2007 Australia
Country 99623 0
Australia
Phone 99623 0
+61 29514 5210
Fax 99623 0
Email 99623 0
[email protected]
Contact person for scientific queries
Name 99624 0
Cristina C. Caperchione
Address 99624 0
Cnr Moore Park Road and Driver Avenue, Moore Park, NSW 2021
PO Box 123. Broadway NSW 2007 Australia
Country 99624 0
Australia
Phone 99624 0
+61 29514 5208
Fax 99624 0
Email 99624 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


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.