Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001240538
Ethics application status
Approved
Date submitted
20/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of the Choose to Move program in Sydney Australia for people aged 50 and over
Scientific title
Evaluating Implementation of the Choose to Move program in Sydney Australia for people aged 50 and over
Secondary ID [1] 312624 0
None
Universal Trial Number (UTN)
U1111-1311-1269
Trial acronym
CTM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 334568 0
Condition category
Condition code
Public Health 331170 331170 0 0
Health promotion/education
Physical Medicine / Rehabilitation 331884 331884 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Choose to Move (CTM) is a community-based program, co-designed with older adults, that increases physical activity and mobility and reduces social isolation.

The Choose to Move program was successfully developed and implemented in Canada by the Active Aging Research Team at the University of British Columbia, with funding from the Government of British Columbia. Choose to Move was rigorously developed with implementation science principles. It is scalable, co-designed, adaptable, tailored for communities, and based on authentic partnerships.

Choose to Move integrates behaviour change principles into the following components:

1. A one-on-one consultation (1 x 30-minutes) with the activity coach in week 2. The consultation helps participants set health-related goals and develop a physical activity action plan that fits their routine and suits their interests, goals, abilities, and resources. The consultation session will be delivered face to face or by telephone or videoconference as preferred by the participant. The activity coach will have experience working with older adults and be aware of supports and services in their community to help facilitate physical activity behaviour change. The coaching session is a one-off session and will take place in week two of the program. The session will also draw on evidence-based behaviour change techniques, practice, and theories to help participants set goals, action plan, and provide accountability.

2. Group meetings (8 x 1-hour) led by activity coaches where participants connect with others in their group to share experiences, encourage and motivate each other. Participants learn about various health topics (e.g., falls prevention, stress management, nutrition) and resources available in their communities from the activity coach. Participants receive the most support during the first six weeks of the program. The first six weeks includes contact every week via a one-on-one consultation and 5 group meetings. This provides the individual and group support they need to set goals and to build physical activity into their lives. In the final six weeks, participants attend three group meetings, during weeks 8, 10, and 12. These meetings help keep participants on-track and set longer-term goals as they approach the end of Choose to Move.

The principles for guiding these components are underpinned by the theoretical models of behaviour change (Self-Determination Theory and the COM-B Model). The self-determination theory outlines three aspects of motivation for behaivour change (autonomy, competence and relatedness) whereas the COM-B model provides a framework for three aspects that drive behaviour change (capability, opportunity and motivation). Behaviour change practice techniques will include goal setting and motivational interviewing (MI). These techniques will be used in discussing with participants what physical activity they would like to do and feel they can do and used in the group meetings to enhance socialisation and physical activity engagement. Participants will be encouraged to identify strengths, barriers and strategies to improving physical activity and social connection. Activity coaches will assist planning, self-monitoring and evaluation of these goals.

3. Access to the Choose to Move Website: Participants will have access to the Choose to Move website designed specifically for this study that contains a collection of trusted resources specific to the context of Sydney, Australia. Materials and information include links to exercise videos and printable resources on topics such as strength, balance, flexibility, bone and joint health. Participants will have the ability to access the resources at their own discretion. https://choosetomove.org.au/

4. Facebook page: Participants will have access to the public Choose to Move Facebook page which will have resources and information on physical activity. https://www.facebook.com/ChooseToMovement

5. Resources (Group meeting PowerPoint presentations, handouts and fortnightly newsletters): Each group meeting will have a PowerPoint presentation focused on a specific health topic that the activity coaches will deliver. After each group meeting there is an accompanying handout. It includes a summary of key information specific to individual group meeting as well as links to additional resources. They will emphasise the importance of being active, maintaining of health and physical function. Participants also have the option of signing up for a fortnightly newsletter to receive updates about the program and receive additional resources to help keep active.

Strategies used to monitor adherence will include sessions attendance list (group meeting and one on one check list).
Intervention code [1] 329142 0
Treatment: Other
Intervention code [2] 329325 0
Behaviour
Intervention code [3] 329326 0
Lifestyle
Comparator / control treatment
This is an uncontrolled, single group implementation study that is focused on implementing the Choose to Move program across Sydney, Australia. All participants will receive the Choose to Move program for 3 months, so masking is not required.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338935 0
Self reported moderate physical activity (days per week).
Timepoint [1] 338935 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [1] 437949 0
Self reported functional balance activity
Timepoint [1] 437949 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [2] 437950 0
Health limitations affecting activities
Timepoint [2] 437950 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [3] 437951 0
Ability to walk 400m
Timepoint [3] 437951 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [4] 437952 0
Ability to climb 1 flight of stairs
Timepoint [4] 437952 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [5] 437955 0
Sedentary behaviour
Timepoint [5] 437955 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [6] 437956 0
Quality of life
Timepoint [6] 437956 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [7] 437957 0
Social Isolation
Timepoint [7] 437957 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [8] 437958 0
Loneliness Questionnaire
Timepoint [8] 437958 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [9] 437959 0
Self-perceived balance
Timepoint [9] 437959 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [10] 437960 0
Self-reported fear of falling
Timepoint [10] 437960 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [11] 437961 0
Adverse Events
Timepoint [11] 437961 0
3 months and 9 months post baseline
Secondary outcome [12] 437962 0
Lower extremity function
Timepoint [12] 437962 0
Baseline and 3 month post baseline
Secondary outcome [13] 437963 0
Self-reported muscle strengthening activities
Timepoint [13] 437963 0
Baseline, 3 months and 9 months post baseline
Secondary outcome [14] 439901 0
Reach- Proportion of the intended priority audience (i.e., participants) who participate in the intervention
Timepoint [14] 439901 0
At completion of recruitment of sample size (160 participants) within 4 weeks after study period.
Secondary outcome [15] 439902 0
Adoption- Proportion and representatives of providers or the delivery team that deliver an intervention
Timepoint [15] 439902 0
At the completion of recruitment of activity coaches.
Secondary outcome [16] 439903 0
Fidelity- The extent to which an intervention is implemented as it was prescribed in the intervention protocol - by the delivery team
Timepoint [16] 439903 0
3 months post baseline.
Secondary outcome [17] 439904 0
Dose (Delivered)- Intended units of each intervention component delivered to participants by the delivery team
Timepoint [17] 439904 0
3 months post baseline.
Secondary outcome [18] 439905 0
Implementation determinant: Acceptability (delivery team)- Perceptions among the delivery team that a given intervention is agreeable, palatable, or satisfactory
Timepoint [18] 439905 0
Within 2 weeks after study completion for all 160 participants.
Secondary outcome [19] 439906 0
Implementation determinant: Acceptability (participants)- Perceptions among the participants that a given intervention is agreeable, palatable, or satisfactory
Timepoint [19] 439906 0
3 months post baseline.
Secondary outcome [20] 439907 0
Implementation determinant: Cost- Money spent on design, adaptation and implementation of an intervention. This will be assessed as a composite outcome
Timepoint [20] 439907 0
Weekly for the duration of the entire study period.
Secondary outcome [21] 439908 0
Implementation determinant: Feasibility- Perceptions among the delivery team that an intervention can be successfully used or carried out within a given organisation or setting
Timepoint [21] 439908 0
Within 4 weeks after study completion for all 160 participants.
Secondary outcome [22] 439909 0
Implementation determinant: Context- Aspects of a larger social, political, and economic environment that may influence intervention implementation. This will be assessed as a composite outcome.
Timepoint [22] 439909 0
Weekly for the duration of the entire study period.
Secondary outcome [23] 439910 0
Implementation determinant: Adaptability- Extent to which an intervention can be adapted, tailored, refined, or reinvented to meet local needs. This will be assessed as a composite outcome.
Timepoint [23] 439910 0
Within 4 weeks after study completion for all 160 participants.
Secondary outcome [24] 439911 0
Implementation determinant: Potential for scale-up- The scalability (the ability of a health intervention shown to be efficacious on a small scale and/or under controlled conditions to be expanded under real world conditions to reach a greater proportion of the eligible population while retaining effectiveness of a discrete health program or intervention
Timepoint [24] 439911 0
Within 4 weeks after study completion for all 160 participants.
Secondary outcome [25] 440335 0
Falls
Timepoint [25] 440335 0
Baseline (past 12 months), 3 months (program duration, 9 months (past 6 months post program)
Secondary outcome [26] 440336 0
Falls related injuries
Timepoint [26] 440336 0
Baseline (past 12 months), 3 months (program duration, 9 months (past 6 months post program)

Eligibility
Key inclusion criteria
Inclusion Criteria
The study will involve consenting adults who:
are aged 50 and over.
consider themselves inactive (do less than 150 minutes of moderate physical activity per week).
want to receive support to be more active.
are able to commit to a 3-month program.
live in the community across Sydney.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
The study will exclude adults who:
have insufficient English language skills to fully participate in the program.
have a medical condition that precludes participation in regular physical activity.
have a diagnosed cognitive impairment.
have a progressive neurological disease (e.g., Parkinson‘s disease).
are unable to leave the house independently and walk 10 metres unassisted.
do not have access to internet if choose to do an online class.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size estimation:
16 programs with an average of 10 participants per program will provide a total of 160 participants to detect a difference in the proportion of participants who increase their physical activity level from baseline to 3-months (approximately 1 day/week), allowing for 20% dropout. To attain >80% power to detect an increase in PA of approximately 1 day/wk as per CTM Phase 3 (PA by the single-item measure; T1 = 2.5 d/wk.; T2 = 3.4 d/wk.; SD difference = 2.2) with alpha of 0.05 across two comparisons (T2 vs.T1), an intraclass correlation for PA of 0.05 (to account for the clustered design of participants within programs) and estimated 20% drop out.

Quantitative analysis:
Analyses will be guided by a rigorous statistical analysis plan developed a priori as we have done previously. Continuous primary and secondary outcomes will be analysed using linear regression. Dichotomous secondary outcomes will be analysed with chi-squared tests. Analyses will be conducted using Stata 14 software.

Qualitative analysis:
We will use thematic data analysis to analyse the data from interviews and focus groups. For interviews and focus groups, thematic analysis of the audio files, written transcripts and detailed field-notes will be an iterative process that will occur during and after the period of data collection. We will develop a framework to code all data based on the study aims, interview questions and the major topic areas. Significant ideas and themes will be coded and reviewed by members of the research team. This process will be continued until a point when no new findings are identified from the texts and agreement is reached about the final list of themes by research team members.

Cost effectiveness:
The intervention and implementation costs will be used to create a decision analytic model to conduct a simulated cost-effectiveness analysis. The cost of delivering the program will be estimated based on trial records where the resources required to implement the program will be recorded (e.g. staff time, any additional non-staff resources) and costed using appropriate wage rates and other relevant cost data.
Utility-based quality of life will be measured using the EQ5D-5L and the health utility score, which is expressed as an index value for health, will be calculated from the 5 questions using published Australian scoring algorithms13.
Quality-adjusted life years (QALYs) will be calculated using the health utility score at baseline, and at the 3 and 9-month follow-up. The number of QALYs gained or lost over the 3 and 9 months of follow-up will be calculated by multiplying the time spent in the health state by the relevant health utility score.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
30/06/2026
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 42929 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 317059 0
Government body
Name [1] 317059 0
The NHMRC-CIHR Healthy Cities Implementation Science Team Grant Scheme grant (APP 2018862) will be funding the study
Country [1] 317059 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 319308 0
None
Name [1] 319308 0
Address [1] 319308 0
Country [1] 319308 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315809 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 315809 0
Ethics committee country [1] 315809 0
Australia
Date submitted for ethics approval [1] 315809 0
08/08/2024
Approval date [1] 315809 0
20/09/2024
Ethics approval number [1] 315809 0
2024/HE000347

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

Contacts
Principal investigator
Name 135870 0
Prof Anne Tiedemann
Address 135870 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 2050
Country 135870 0
Australia
Phone 135870 0
+61286276233
Fax 135870 0
Email 135870 0
[email protected]
Contact person for public queries
Name 135871 0
Anne Tiedemann
Address 135871 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 20250
Country 135871 0
Australia
Phone 135871 0
+61286276233
Fax 135871 0
Email 135871 0
[email protected]
Contact person for scientific queries
Name 135872 0
Anne Tiedemann
Address 135872 0
Institute for Musculoskeletal Health, PO Box M179, Missenden Road, Camperdown NSW 20250
Country 135872 0
Australia
Phone 135872 0
+61286276233
Fax 135872 0
Email 135872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participant data for primary and secondary outcomes underlying published results.
When will data be available (start and end dates)?
The data will be accessible 3 months following the date of publication of the main results related to this trial and will be available for a period of 5 years post-publication.
Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator
Available for what types of analyses?
For meta-analysis.
How or where can data be obtained?
Access subject to approval by the Principal Investigator after providing a methodological proposal directed to the Principal Investigator ([email protected]).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24210Ethical approval    2024/HE000347 388203-(Uploaded-20-09-2024-11-27-58)-2024_HE000347 approval.pdf
24211Study protocolV3 Dated 2.9.2024   388203-(Uploaded-20-09-2024-11-31-18)-Choose to Move Protocol V3 02.09.2024_Clean.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.