Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001267246
Ethics application status
Approved
Date submitted
21/07/2018
Date registered
27/07/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A co-designed physical activity intervention delivered online for first responders and their partners
Scientific title
A co-designed physical activity intervention delivered online for first responders and their partners: A pilot study
Secondary ID [1] 295299 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental illness 308493 0
Physical inactivity 308494 0
Condition category
Condition code
Mental Health 307470 307470 0 0
Depression
Mental Health 307794 307794 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 307855 307855 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will recruit sedentary first responders and their chosen support partner to a 10-week, group based physical activity promotion intervention delivered online through a private Facebook group. The group will allow members to receive information and contribute to weekly conversations on pre-specified topics related to physical activity eg. sedentary behaviour, goal setting, benefits of physical activity and support. One topic will be covered each week for the 10 weeks with 2-3 Facebook posts on the topic each week. The content of each topic is designed specifically for this study but will also make use of existing videos, pictures and information sources. The purpose of the Facebook group is to facilitate social support and provide participants with a platform to exchange personal experiences including barriers and facilitators to commencing and maintaining a physical activity program. While discussion topics will be pre-determined, discussion will change weekly based on the participants posts for example someone may ask for examples of workouts or different ways overcome barriers. All participants will also be provided with a Fitbit flex 2 and encouraged to set daily goals and track their physical activity levels as a way to support self-monitoring. Goals such as increasing steps by 15% each week and getting up every hour will be advised. Participants will also have access to the FitBit's wellness program. On here they will be able to see the physical activity levels of others in the study and compete in step counts. The intervention itself will go for 10 weeks however there is the option for participants to remain in the Facebook group and continue to use it for support without the input from the facilitators. All 20 participants will be included in the one Facebook group and encouraged to check the Facebook weekly. The page will be monitored by a member of the research team at least 5 times per week. Contribution to the page in regards to posting/liking material is optional.

There will be a follow up period of one month as well as month of data collection prior to the intervention where participants will just be required to complete questionnaires to obtain baseline data. This interrupted time series design will replace the need for a control group.

The iterative development of this intervention has occurred through collaboration with project advisors with lived experience of working as a first responder, and of living with mental illness related to occupational trauma. They will act as peer support within the Facebook group, while the researchers (exercise physiologists and psychologists) will guide the group. The research team will have access to the one Facebook account designed for the study while the two peer support members will use their personal accounts.

Adherence to the Facebook including page views, comments and likes will be calculated manually.
Intervention code [1] 301634 0
Prevention
Intervention code [2] 301635 0
Treatment: Other
Comparator / control treatment
Participants' baseline data will be used as a control.
Control group
Active

Outcomes
Primary outcome [1] 306457 0
*Composite primary outcome: Feasibility -defined by: 1. Usage of the Facebook group (manual calculation of the sum of comments, likes and page views) 2. Fitbit compliance (% of days worn) 3. Participant retention (in program and completion of questionnaires).
Timepoint [1] 306457 0
1. Post intervention (week 15)
2. Post intervention (week 15)
3. Post intervention (week 15)
Secondary outcome [1] 348609 0
Psychological distress- using the Kessler 10 questionnaire.
Timepoint [1] 348609 0
Every 2 weeks from 4 weeks prior to commencement of intervention to 4 weeks post completion of intervention (weeks 1-19).
Secondary outcome [2] 348610 0
Sleep quality- using the Pittsburgh Sleep Quality Index
Timepoint [2] 348610 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [3] 348611 0
PCL-5 - self reported symptoms of post traumatic stress disorder. This will only be measured in first-responders, not their partners.
Timepoint [3] 348611 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [4] 348612 0
DASS-21- measure of depression, anxiety and stress.
Timepoint [4] 348612 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [5] 348613 0
AQoL-6D- quality of life
Timepoint [5] 348613 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [6] 348614 0
Social support and exercise: survey (Sallis et al., 1987). Adapted to past month only for this study.
Timepoint [6] 348614 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [7] 348615 0
Mental Health Service utilisation (using participant reported data)
Timepoint [7] 348615 0
Prior to intervention (week 5), post intervention (week 15) and follow up (week 19).
Secondary outcome [8] 349978 0
Acceptability
1. Using the 14-item feasibility and acceptability questionnaire that has been used previously to measure participant responses to a private Facebook group (Naslund, 2016)
2. Qualitatively- participants will also be invited to participate in a one-on-one semi-structured interview via Skype.
Timepoint [8] 349978 0
1. Post intervention (week 15)
2. Post intervention (week 15)
Secondary outcome [9] 349981 0
Minutes of physical activity as assessed by both:
1. Objective (Fitbit data)
2. Self-report (Simple Physical Activity Questionnaire)
Timepoint [9] 349981 0
1. Daily steps and active minutes (weeks 5-15 and follow up 15-19)
2. Every 2 weeks from 4 weeks prior to commencement of intervention to 4 weeks post completion of intervention (weeks 1-19).

Eligibility
Key inclusion criteria
This research study is looking to recruit a convenience sample of i) former or current first responders, ii) aged 18-65 years, iii) currently inactive defined as engaging in less than 150 mins per week of moderate-vigorous physical activity per week, iv) cleared to participate in an exercise program (absence of any American College of Sports Medicine (ACSM) absolute contraindications to exercise participation). Participants must also speak English, have internet access and an active Facebook account or be willing to create one.
First responders must also nominate their support partner/carer who may be any person with a close personal relationship to them eg. partner, family member, friend who have at least weekly in-person contact with each other. This person must also be between 18-65 years and be medically absent from any ACSM absolute contraindications to exercise.

Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Although we will not specifically target those first responders with a diagnosed mental disorder, by nature of the target population, it is expected that a high proportion of the participants will be receiving treatment for a mental disorder. Severely depressed individuals or those experiencing frequent suicidal ideation at the outset will be excluded from the study and directed towards appropriate services in their community. Participants will be screened prior to commencement of the study and those who receive a score in the K-10 questionnaire of >30 will be contacted by the research team. If these participants are not receiving treatment the research team will recommended they do and then excluded them from the study. Likewise, those whose medications have changed in the past 4 weeks will also be excluded.

Participants will also be screened with the physical activity vital sign and the ESSA pre-screening tool. First-responders who exceed 150mins of moderate-vigorous PA will be excluded and those who answer yes to any of the 7 ESSA pre-screening questions must get clearance to exercise from a general practitioner.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
The study will follow an interrupted time series design. This involves the collection of data on multiple instances over time before an intervention is introduced to detect whether the intervention has an effect significantly greater than the underlying secular trend. It also replaces the need for a control group in this pilot study. Therefore, the K10 and The Simple Physical Activity Questionnaire (SIMPAQ) will be measured at baseline at 3 timepoints prior to the study (week 1, 3 and 5). The intervention itself will then commence at week 5 and run for 10 weeks. The K10 and SIMPAQ will continue to be sent out every two weeks for the duration of the study. Additional outcomes will only be assessed at weeks 5 (pre-intervention), week 15 (post-intervention) and week 19 (follow up).
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
28/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 20827 0
Canada
State/province [1] 20827 0

Funding & Sponsors
Funding source category [1] 300155 0
Self funded/Unfunded
Name [1] 300155 0
NA
Country [1] 300155 0
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 299563 0
None
Name [1] 299563 0
NA
Address [1] 299563 0
NA
Country [1] 299563 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300736 0
The University of New South Wales Research Ethics Committee: DVCR RECS Human Ethics
Ethics committee address [1] 300736 0
Ethics committee country [1] 300736 0
Australia
Date submitted for ethics approval [1] 300736 0
20/07/2018
Approval date [1] 300736 0
24/08/2018
Ethics approval number [1] 300736 0
HC180561

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

Contacts
Principal investigator
Name 84642 0
Dr Simon Rosenbaum
Address 84642 0
The Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 84642 0
Australia
Phone 84642 0
+61 415 435 125
Fax 84642 0
Email 84642 0
[email protected]
Contact person for public queries
Name 84643 0
Grace McKeon
Address 84643 0
The Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 84643 0
Australia
Phone 84643 0
+61 434 041 357
Fax 84643 0
Email 84643 0
[email protected]
Contact person for scientific queries
Name 84644 0
Grace McKeon
Address 84644 0
The Black Dog Institute
Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
Country 84644 0
Australia
Phone 84644 0
+61 434 041 357
Fax 84644 0
Email 84644 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
Individual participant data may be easily identifiable by those within the same intervention group based on their physical activity levels, occupation, age etc.


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.