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Trial registered on ANZCTR


Registration number
ACTRN12620000559910
Ethics application status
Approved
Date submitted
17/04/2020
Date registered
13/05/2020
Date last updated
13/05/2020
Date data sharing statement initially provided
13/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Choices: effectiveness and feasibility of a ‘stepped down’ program on self-managed physical activity and social connectedness in Australian war veterans and their dependents
Scientific title
Active Choices: effectiveness and feasibility of a ‘stepped down’ program on self-managed physical activity and social connectedness in Australian war veterans and their dependents
Secondary ID [1] 301056 0
ARP-1806
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 317111 0
Loneliness 317112 0
Condition category
Condition code
Public Health 315274 315274 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active Choices is a 12-week ‘stepped down’ program that supports Department of Veterans’ Affairs (DVA) clients (i.e., Australian war veterans, war widows and their dependents), who are currently receiving DVA-funded treatment from an allied health professional, to self-manage their physical activity (PA) regimes and form new social connections.

The program is based in Michie and colleagues’ (2011) COM-B Framework. Program development was informed by a systematic review conducted by our team (Gilson et al., 2019), which examined the effectiveness of ‘stepped down’ PA programs for veterans and their dependents, and the key effective strategies used in these programs to promote self-managed PA. The behaviour change strategies identified as most effective in this review are incorporated within the Active Choices program, and are education, goal setting, goal review, self-monitoring, social support, action planning, barrier identification and problem-solving.

(1) Consultations
The Active Choices program consists of 4 consultations, which clients complete individually with a member of the Active Choices team, during Weeks 1, 4, 8 and 12. The consultations in Week 1 and 12 are conducted face-to-face at the UQ PA Laboratory or a location of convenience for the client (e.g., at the allied health practice they attend) and run for 1-hour. The consultations in Week 4 and 8 are conducted via telephone and run for 30-minutes.

During the Week 1 Consultation, clients receive education about PA and are supported in developing their individualised Active Choices program for weeks 1 to 4. This involves identifying the client’s PA preferences and linking these to local opportunities for those activities in their community, setting PA goals, developing a PA plan, identifying barriers to PA and problem-solving solutions to overcome these. Clients are also linked to other participating clients in their area to facilitate the formation of physical activity social groups.

During the Week 4 Consultation, clients review their progress during weeks 1 to 4, and are supported in developing their individualised Active Choices program for weeks 5 to 8 using the same strategies and processes as in the Week 1 Consultation. They also are linked to other participating clients in their area.

During the Week 8 Consultation, clients review their progress during weeks 5 to 8, and are supported in developing their individualised Active Choices program for weeks 9 to 12 using the same strategies and processes as in the Week 1 Consultation. They also are linked to other participating clients in their area.

During the Week 12 Consultation, clients review their progress during weeks 9 to 12, and are supported in developing their plan for continuing to self-manage their PA beyond the program using the same strategies and processes as in the Week 1 Consultation.

(2) Resource Booklet
Consultations are guided by the Active Choices resource booklet, which contains educational and behavioural support materials that map onto the behaviour change strategies incorporated within the program. This resource booklet is also used by clients throughout the 12-week program to self-monitor their PA and as an educational resource. The resource booklet was designed specifically for the Active Choices program.

(3) SMS Reminders
SMS reminders are sent to clients the day before their PA choices in Week 2, 5 and 9.

(4) Financial Support
The Active Choices program provides financial support (of up to $20/week) for clients to access their PA choices.

Intervention adherence will be assessed by PA log data recorded in the resource booklet, and through interviews conducted at end-intervention.

*Michie, S., van Stralen, M., & West, R. (2011). The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implementation Science, 6 (42).

*Gilson, N., Papinczak, Z., Mielke, G., Haslam, C., McKenna, J., & Brown, W. (2019). Intervention Strategies to Promote Self-Managed Physical Activity in Service Veterans and their Dependents – A Rapid Evidence Assessment (Technical Report).
Intervention code [1] 317358 0
Treatment: Other
Intervention code [2] 317359 0
Lifestyle
Intervention code [3] 317360 0
Behaviour
Comparator / control treatment
The comparator program involves less contact with the Active Choices team and fewer behavioural support strategies than the Active Choices program. These behaviour change strategies are education, self-monitoring and action planning.

(1) Consultations
The comparator program consists of 2 consultations, which clients complete individually with a member of the Active Choices team, during Weeks 1 and 12. These consultations are conducted face-to-face at the UQ PA Laboratory or a location of convenience for the client (e.g., at the allied health practice they attend) and run for 1-hour.

During the Week 1 Consultation, clients receive education about PA and are supported in identifying their PA preferences. They are given materials to help them identify local opportunities for their PA choices, and to develop their PA action plan at home.

During the Week 12 Consultation, clients reflect on their progress during the past 12-weeks and identify their PA action for continuing to self-manage their PA into the future.

(2) Resource Booklet
Consultations are guided by a resource booklet, which contains educational and behavioural support materials that map onto the behaviour change strategies incorporated within the program. This resource booklet is also used by clients throughout the program to self-monitor their PA and as an educational resource. The resource booklet was designed specifically for the comparator program.

(3) Financial Support
The comparator program provides financial support (of up to $20/week) for clients to access their PA choices.
Control group
Active

Outcomes
Primary outcome [1] 323516 0
Change in weekly minutes spent in self-managed physical activity, measured using ActiGraph accelerometers.
Timepoint [1] 323516 0
ActiGraph accelerometers will be worn for 24hours during 7 consecutive days at baseline, end-intervention (12 weeks - primary timepoint) and follow-up (24 weeks). A log of wear time will also be completed during the 7-day period at each assessment timepoint.
Primary outcome [2] 323662 0
Change in weekly minutes spent in moderate-to-vigorous intensity physical activity, measured using ActiGraph accelerometers.
Timepoint [2] 323662 0
ActiGraph accelerometers will be worn for 24hours during 7 consecutive days at baseline, end-intervention (12 weeks - primary timepoint) and follow-up (24 weeks). A log of wear time will also be completed during the 7-day period at each assessment timepoint.
Primary outcome [3] 323663 0
Change in weekly minutes of sedentary behaviour, measured using ActiGraph accelerometers.
Timepoint [3] 323663 0
ActiGraph accelerometers will be worn for 24hours during 7 consecutive days at baseline, end-intervention (12 weeks - primary timepoint) and follow-up (24 weeks). A log of wear time will also be completed during the 7-day period at each assessment timepoint.
Secondary outcome [1] 382117 0
Change in social connectedness, measured using the online Social Identity Mapping tool (Cruwys et al., 2016), Multiple Group Memberships scale (Haslam et al., 2008) and Loneliness scale (Hughes et al., 2004).

*Cruwys et al. (2016). Social Identity Mapping: A procedure for visual representation and assessment of subjective multiple group memberships. British Journal of Social Psychology, 55(4), 613-642.

*Haslam et al. (2008). Maintaining group membership: Identity continuity and well-being after stroke. Neuropsychological Rehabilitation, 18, 671-691.

*Hughes et al. (2004). A short scale for measuring loneliness in large surveys. Research on Aging, 26, 655-672
Timepoint [1] 382117 0
Measures will be completed at baseline, end-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [2] 382119 0
Change in psychological well-being, measured using the Satisfaction with Life scale (Diener et al., 1985).

*Diener et al. (1985). The Satisfaction with Life Scale. Journal of Personality Assessment, 49, 71-75.
Timepoint [2] 382119 0
Surveys will be completed at baseline, end-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [3] 382120 0
Change in health-related quality of life, measured using the EQ-5D-5L (Herdman et al., 2011).

*Herdman et al. (2011). Development and preliminary testing of the new five-level version of the EQ-5D (EQ-5D-5L). Quality of Life Research, 20, 1727-1736.
Timepoint [3] 382120 0
Surveys will be completed at baseline, end-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [4] 382121 0
DVA-funded allied health service utilisation and costs incurred for these services during the intervention and follow-up period, measured using DVA administration data.
Timepoint [4] 382121 0
Retrospective administration data will be obtained from the DVA at the end of the 24-week study period.
Secondary outcome [5] 382122 0
Acceptability of the program, measured through qualitative interviews.
Timepoint [5] 382122 0
Interviews will be conducted at end-intervention (12 weeks) and follow-up (24 weeks).
Secondary outcome [6] 382123 0
Barriers and facilitators to program implementation (a composite outcome), measured through qualitative interviews.
Timepoint [6] 382123 0
Interviews will be conducted at end-intervention (12 weeks) and follow-up (24 weeks).

Eligibility
Key inclusion criteria
Eligible participants are Brisbane-based DVA clients (i.e., Australian war veterans, war widows and their dependents), aged over 50 years, who are currently receiving DVA-funded allied health treatment from an exercise physiologist or physiotherapist, and are identified by their treating allied health professional as able to safely participate in a self-managed physical activity program.
Minimum age
51 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vulnerable groups under medical management for chronic or complex conditions are unable to participate in this study. These conditions are:
*Post-traumatic stress disorder
*Spinal cord injury
*Brain injury
*Severe mental health conditions
*Chronic pain
*Stroke
*Amputations
*Complicated orthopaedic injury
DVA clients already participating in a DVA-funded physical activity program and current serving Australian Defence Force personnel are also ineligible for this research.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed. This is due to a cluster randomised design in which participants are allocated by allied health practice.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated and clustered by allied health practice. Each practice will be assigned a number and a simple computerised sequence generation will be used to allocate practices to treatment groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample sizes are calculated on change in moderate-to-vigorous physical activity (PA) (assessed through accelerometers), from baseline to 24 weeks, between the two groups. In order to detect a minimum increase of 11 mins/day in moderate-to-vigorous PA, assuming an average of 10.1 mins/day (standard deviation of 12.7 mins/day) at baseline, a power of 80% and significance level of 5%, the sample size requires 21 participants in each group. To allow for 20% loss to follow-up and 10% non-compliance of the physical activity device, 104 participants will be recruited to the study. The reference parameters used to calculate the sample size were based on a recent large-scale survey conducted, which examined accelerometer measured PA in nearly 600 adults living in Brisbane.

Basic descriptive statistics will be used to summarise the demographic characteristics of participants, and data will be checked for parametric assumptions.

Intention-to-treat analyses will be conducted using linear mixed effects modelling to examine within- and between-group changes in accelerometer measured PA, psychological well-being and social connectedness. Sensitivity analyses will be conducted to assess the robustness of the findings, and for exploratory purposes, sub-group analyses will be performed by gender, age group and treatment history and number of risk factors. The results of all comparative analyses will be presented with 95% confidence intervals, and statistical significance for main effects will be assessed at the 5% level. Statistical analyses will be conducted using Stata v15.

For cost utilisation, the research team will determine the costs of each condition, inclusive of both the direct costs of implementing the intervention, and the implied cost to the DVA (such as the higher or lower utilisation of services relative to group allocation). Difference-in-difference analysis will be used to identify if Active Choices may be cost-saving to the DVA, due to a possible reduction in the use of allied health services.

For qualitative data analyses, members of the research team will thematically analyse and independently review interview data, and discuss the range of client responses, to agree on key themes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 305499 0
Government body
Name [1] 305499 0
Department of Veterans’ Affairs
Address [1] 305499 0
GPO Box 9998
Brisbane QLD 4000
Country [1] 305499 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Nicholas Gilson
Address
School of Human Movement Studies and Nutrition Sciences
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 305896 0
None
Name [1] 305896 0
Address [1] 305896 0
Country [1] 305896 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305810 0
Department of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 305810 0
CP3-7-038, Campbell Park Offices, PO Box 7912
Canberra ACT 2610
Ethics committee country [1] 305810 0
Australia
Date submitted for ethics approval [1] 305810 0
21/09/2019
Approval date [1] 305810 0
13/12/2019
Ethics approval number [1] 305810 0
DDVA HREC/OUT/2019/BN11979933
Ethics committee name [2] 305811 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 305811 0
The University of Queensland
St Lucia QLD 4072
Ethics committee country [2] 305811 0
Australia
Date submitted for ethics approval [2] 305811 0
16/01/2020
Approval date [2] 305811 0
31/01/2020
Ethics approval number [2] 305811 0
2020000034/163-19

Summary
Brief summary
A ‘stepped down’ physical activity (PA) program is one in which clients transition from the care of an allied health professional to self-managed PA. Assisting clients in ‘stepping down’ to self-managed PA may promote a range of positive health outcomes that are associated with regular PA, such as enhanced physical and cognitive function, reduced risk of chronic diseases, improved quality of life and enhanced psycho-social wellbeing. Furthermore, ‘stepped down’ PA programs may help in sustaining the health benefits achieved through allied health treatment.

Presently, health care treatment models provided by the Department of Veterans Affairs (DVA) may not enable or create channels for its clients, who are Australian war veterans and war widows, to ‘step down’ to self-managed PA following a course of allied health treatment.
There are also questions about improving the sustainability of self-managed PA in DVA clients when undertaken in communities that might facilitate physical and psychological health, social connectivity, and health care savings.

To respond to this unmet service need, the Active Choices program was developed for DVA clients who are currently receiving allied health treatment from an exercise physiologist or physiotherapist. Active Choices is a 12-week program that incorporates evidence-based behavioural support strategies (e.g., goal setting, self-monitoring, action planning) to help DVA clients self-manage their PA. The program also links DVA clients to local opportunities for their PA choices, provides financial support to access community PA, and promotes social connectivity within local active communities.

This research aims to evaluate the effectiveness, feasibility and acceptability of the Active Choices program in a sample of DVA clients. The impact of the program on self-managed PA, psychological well-being, social connectedness and allied health care utilisation will be assessed. The research will also explore barriers and facilitators to program implementation, aspects of the program that clients did and did not like, and areas in which the program may be improved in future.

A clustered randomised controlled trial will be conducted, with allied health practices randomly allocated to the Active Choices program or a comparator program that involves less contact with the Active Choices team and incorporates fewer behaviour change strategies.

Measures of program effectiveness will be completed at baseline, end-intervention (12 weeks) and follow-up (24 weeks). Program feasibility and acceptability will be assessed at the end-intervention and follow-up timepoints.

It is hypothesised that relative to the comparator program, the Active Choices program will benefit self-managed PA, psychological wellbeing, social connectivity and allied health care utilisation.

The findings of this research will provide valuable data to support larger effectiveness trials.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101678 0
A/Prof Nicholas Gilson
Address 101678 0
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia QLD 4072
Country 101678 0
Australia
Phone 101678 0
+61 7 3365 6114
Fax 101678 0
Email 101678 0
n.gilson1@uq.edu.au
Contact person for public queries
Name 101679 0
A/Prof Nicholas Gilson
Address 101679 0
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia QLD 4072
Country 101679 0
Australia
Phone 101679 0
+61 7 3365 6114
Fax 101679 0
Email 101679 0
n.gilson1@uq.edu.au
Contact person for scientific queries
Name 101680 0
A/Prof Nicholas Gilson
Address 101680 0
School of Human Movement and Nutrition Sciences
The University of Queensland
St Lucia QLD 4072
Country 101680 0
Australia
Phone 101680 0
+61 7 3365 6114
Fax 101680 0
Email 101680 0
n.gilson1@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For data privacy reasons, our ethics approval does not allow us to share individual participant data. Results will be published at the aggregated group-level.
What supporting documents are/will be available?
No other documents available
Summary results
No Results