Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001256763
Ethics application status
Approved
Date submitted
9/09/2022
Date registered
20/09/2022
Date last updated
20/09/2022
Date data sharing statement initially provided
20/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The ENJOY Seniors Exercise Park IMP-ACT project: IMProving older people’s health through physical ACTivity
Scientific title
The ENJOY Seniors Exercise Park IMP-ACT project: IMProving older people’s health through physical ACTivity: a hybrid II implementation project design investigating the impact of a novel intervention on physical activity participation
Secondary ID [1] 307953 0
MRFF - MRF2015933
Universal Trial Number (UTN)
Trial acronym
ENJOY IMP-ACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic conditions associated with physical inactivity 327608 0
Condition category
Condition code
Public Health 324695 324695 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Five local governments (6 public sites/parks) will undergo 9-month implementation intervention incorporating key elements of the TERM framework intervention: Training, Engagement, Resources development and Marketing and promotion.
All participating sites have a specialized outdoor equipment, Seniors Exercise Parks, already installed in their parks. The Seniors Exercise Park incorporates exercise stations that target balance, function, range of movement and strength.
Training - knowledge transfer:
Senior champions/leaders (community members) from each site will participate in a 5-week "train the trainer" program, 1.5 hour sessions per week for 5 weeks. They will be learn how to welcome and train other community members at the site. The training will be delivered by a qualified exercise instructor/research staff. Two training modules will be delivered per site, one at the beginning of the intervention period and the second one toward the end.

Allied health professionals will be provided with a half-day workshop training program at the exercise park site. This will cover safe use, exercise prescription and program design, incorporating risk management, theoretical and practical sessions. The training workshop will be delivered after the completion of the 'train the trainer' or towards the last two weeks of the train the trainer completion. The workshop will be delivered by the member of the research team. Variation in time of delivery is expected to account for potential weather impact.

Induction sessions by qualified research staff – 12 sessions (once weekly for 1 hour per session) will be offered at each site for clients referred from local GP clinics or community health. The sessions will include induction and familiarisation on the exercise equipment for future safe independent usage. The sessions will be supervised by a qualified research staff. Adherence will be monitored using an attendance checklist. The induction sessions will be run after train the trainer and the allied health professional training workshop.

Engagement:
Communities will be engaged through local community events (e.g. open days, Seniors' Weeks, Community Health expos, come and try sessions), local advisory groups at each site which will include local stakeholder representatives (e.g. leisure centres, community health centres, council staff, senior champions, community consumers). Community engagement activities will occur approximately 6 weeks from the commencement of the intervention period and will be determined by the council staff in discussion with the research team. The local advisory committee will be formed at the commencement of the intervention period and will meet every 6-8 weeks. The local advisory committee role is to provide advice on matters related to supporting the delivery of the research project within the municipality, and advising strategies to support longer term and broader translational activities beyond the term of this project. The Local Advisory will advise on activation of the site, increase community engagement and maximise participation.

Resource Development:
Our project resources will include information about the benefits of physical activity and safe usage of the equipment. These resources will comprise on-site information (instructional signage with friendly illustrations), traditional hard copy flyers, and an online platform (website, video resources and the ENJOY-ME-APP smartphone app). Workshop and training resources will also be developed including on-line resources (video materials) and written educational materials (e.g., manuals). Resources will designed specifically for this study and be available once the intervention period has commenced at each site and will be used throughout the intervention period as needed.

Marketing and Promotion:
Marketing and promotion will take place in collaboration with the communication team within each council to reach community members using various platforms: mail out flyers, on-site signage, newsletter stories, local radio stations, social media, and video promotions/photo shoots. As we anticipate variation in the marketing/promotion strategies between councils, we will develop a core strategy that is adjustable based on council structures and resources. This will include a social marketing approach, combining communications with supportive policies, environments and opportunities for physical activity.

The outdoor Seniors Exercise Parks are freely available for the public, and community members will be able to use them with no supervision. Supervision of usage will only take place during the activities listed above by a qualified member of the research team/staff for any community members/participants/visitors attending these activities.
Intervention code [1] 324408 0
Prevention
Comparator / control treatment
The 3 months baseline period will serve as a control period (comparator). During that 3 months control period the park will be available for public to use but no activities (as listed under the intervention) will take place (e.g., training or community events).
Control group
Active

Outcomes
Primary outcome [1] 332510 0
Number of older people who engage in physical activity using the Seniors Exercise Park - will be measured using a modified version of the System for Observing Play and Recreation in Communities (SOPARC). The SOPARC is based on momentary time sampling techniques in which systematic and periodic scans of individuals and contextual factors within pre-determined target areas in parks are made.
Timepoint [1] 332510 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).
Primary outcome [2] 332511 0
Physical activity level of older people users. This will be collected during face-to-face intercept surveys with older people who utilise the equipment using the Self-reported physical activity questionnaire from the Active Australia Survey. The survey assesses walking, moderate, and vigorous activity, plus an indicator of total activity. The Active Australia questions are valid, reliable and recommended for use in Australian population-based research. This will provide measures of time and frequency of physical activities and also identify any changes not likely to be attributable to the program (such as walking), and provide a comparator to nationally representative data.
Timepoint [2] 332511 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).
Data will be collected during the periodic observation (SOPARC).
Secondary outcome [1] 413784 0
Older people users physical and health characteristics - this will be collected via face-to-face intercept surveys. The questions will ask about socio-economic and demographic characteristics, if the user is a local resident or visitor, motivation to use the Seniors Exercise Park equipment, how often they visit the park, social connectedness/engagement with other people at the park, their general physical activity level and leisure/recreation activity at the park, general health and wellbeing, social and health care service utilisation, leisure activities and occupation details. The characteristics will be assessed as a composite secondary outcome.
Timepoint [1] 413784 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).
Secondary outcome [2] 413785 0
Type of usage and uptake of the Exercise park.
Audits of the number, type of programs (supervised/unsupervised), and program characteristics (duration, frequency, staff profession) will be conducted. This is a composite secondary outcome. Member of the research team will use a bespoke survey (online form or via word file) and/or through direct communication with the relevant council staff as a method to usage uptake.
Timepoint [2] 413785 0
At the completion of the intervention, and 3 months post implementation (maintenance phase).
Secondary outcome [3] 413786 0
Online access monitor platform - ENJOY-ME APP.
The e-monitor tracker platform will collect information on usage of the online platform such as frequency, time and date.
Timepoint [3] 413786 0
On going - data will be collected from the implementation intervention commencement and throughout the maintenance phase (3 months post completion of the intervention phase).
Secondary outcome [4] 413787 0
Training audit and evaluation.
Process evaluation of the training (allied health professional and train the trainer) will include: evaluation of the number of workshops/training programs delivered for allied health professionals and senior champions. Evaluation of the number of workshops delivered to allied health professionals will be determined from an audit of study training logs. A record of the participants will be kept (including their profession, year and nature of experience); and a structured evaluation of participants (knowledge gained and feedback) will be undertaken. Both evaluations will be assessed as a composite secondary outcome.
Timepoint [4] 413787 0
Monthly during the 9-month implementation intervention phase
Secondary outcome [5] 413788 0
Barriers and facilitators to implementation at a community/organisational level.
To understand community level factors (e.g., funding, policy, internal structure) that potentially impact implementation (barriers/facilitators), semi-structured interviews with key representatives from partner organisations (local government, and local healthcare /leisure/ recreation providers) will be conducted.
Semi-structured interviews will also be collected with leaders of delivery programs (senior group leaders, allied health professionals, exercise instructors) using the outdoor equipment to understand provider characteristics, and barriers and facilitators experienced throughout their involvement with the Seniors Exercise Parks. Feedback will be assessed as a composite secondary outcome.
Timepoint [5] 413788 0
Once during the 9-month intervention phase and once during the maintenance phase ( 3 months post-completion of the intervention) at each site.
Secondary outcome [6] 413789 0
Social-return on investment
The information about the cost investment of participating councils will be collected via an online survey: capital costs (purchase, installation and setup); implementation costs (e.g,. planning meetings, staff recruitment, marketing, communications, education to Australian Health Professionals and community leaders); running costs (e.g., health professionals, admin team, including the training costs for the allied health professionals and senior champions) and maintenance costs (e.g., equipment maintenance). The survey is designed specifically for this study.
Timepoint [6] 413789 0
Periodically approximately every 6-12 weeks during baseline, the 9-month intervention phase and maintenance phase (3 months post-completion of the intervention). This may vary depends on the council staff availability.
Secondary outcome [7] 413839 0
Self-reported physical activity - will be measured using three questions from the Active Australia Survey
Timepoint [7] 413839 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).
Secondary outcome [8] 413840 0
General wellbeing will be assessed using the five-item World Health Organization (WHO-5) Wellbeing questionnaire. The WHO-5 measures psychological wellbeing and depressive symptoms using 5 simple questions.
Timepoint [8] 413840 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).
Secondary outcome [9] 413841 0
Quality of life using the EQ-5D-5L
Timepoint [9] 413841 0
Evaluation will take place during the control period (baseline), and every 3 months during the 9 month implementation intervention phase, and immediately post intervention up to 3 months post implementation (maintenance phase).

Eligibility
Key inclusion criteria
For the face-to-face intercept survey at the park, the following inclusion criteria will be applied: (1) adults aged 60 and over, (2) adults who are able to understand basic English and have conversational English.

For the semi-structured interviews for the contextual factors influencing the implementation, the following inclusion criteria will be applied: (1) key stakeholder representatives - council staff within the division (or equivalent) that are responsible or involved with the Seniors Exercise Park management/coordination/activation; community health/leisure centre managers/coordinators within the participating municipalities; (2) leaders of delivery programs (senior group leaders, allied health professionals, exercise instructors) who utilise the Seniors Exercise Park as part of their program/service delivery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The following exclusion criteria will be applied for the face-to-face intercept surveys at the park: (1) participants who identify themselves as less than 60 years of age and (2) who are unable to understand basic conversational English.

The following exclusion criteria will be applied for the key stakeholder representatives and leaders of delivery programs interviews: staff that are not directly involved with the management or activation of the Seniors Exercise Park or do not deliver programs/services using the outdoor equipment.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a type II hybrid effectiveness–implementation study, using a pre-post study design.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to report the overall number of older people using exercise equipment as well as the type of usage and uptake, survey responses.

A generalised linear model (with main effects for intervention, site, season and their interaction) will be used to examine the effectiveness of the implementation intervention on the total number of older people (primary outcome) using the equipment assuming a quasi-poisson distribution. Linear / logistic regression models (with main effects for site, time-point, season and their interaction) to examine the impact of the implementation intervention on the secondary measures: physical activity level and wellbeing.

Economic Evaluation: The Social Return on Investment will be blended with a traditional cost-benefit analysis.

Qualitative analysis: Semi-structured interviews with key stakeholders will be audio recorded, professionally transcribed and analysed using NVivo 12 software. The interview transcripts will be thematically analysed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
360
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312219 0
Government body
Name [1] 312219 0
The Commonwealth of Australia - Medical Research Future Fund (MRFF)
Country [1] 312219 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
34-54 Poplar Road, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 313752 0
None
Name [1] 313752 0
None
Address [1] 313752 0
Country [1] 313752 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311598 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 311598 0
Ethics committee country [1] 311598 0
Australia
Date submitted for ethics approval [1] 311598 0
07/09/2022
Approval date [1] 311598 0
15/09/2022
Ethics approval number [1] 311598 0

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

Contacts
Principal investigator
Name 121666 0
Prof Pazit Levinger
Address 121666 0
National Ageing Research Institute
PO Box 2127, Royal Melbourne Hospital, Victoria 3050
Country 121666 0
Australia
Phone 121666 0
+61383872626
Fax 121666 0
Email 121666 0
[email protected]
Contact person for public queries
Name 121667 0
Pazit Levinger
Address 121667 0
National Ageing Research Institute
PO Box 2127, Royal Melbourne Hospital, Victoria 3050
Country 121667 0
Australia
Phone 121667 0
+61383872305
Fax 121667 0
Email 121667 0
[email protected]
Contact person for scientific queries
Name 121668 0
Pazit Levinger
Address 121668 0
National Ageing Research Institute
PO Box 2127, Royal Melbourne Hospital, Victoria 3050
Country 121668 0
Australia
Phone 121668 0
+61383872305
Fax 121668 0
Email 121668 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
No individual data be available due to ethics requirements, only group data be reported


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17106Study protocol    A protocol paper will be submitted in due course a... [More Details]



Results publications and other study-related documents

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