Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000965808
Ethics application status
Approved
Date submitted
17/06/2021
Date registered
23/07/2021
Date last updated
23/07/2021
Date data sharing statement initially provided
23/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
ENJOY MAP for HEALTH: outdoor exercise for older people
Scientific title
The ENJOY MAP for HEALTH: Exercise interveNtion outdoor proJect in the cOmmunitY for older people
Secondary ID [1] 302532 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
ENJOY MAP for HEALTH
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Chronic conditions associated with physical inactivity 319400 0
Condition category
Condition code
Public Health 317368 317368 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project involves the installation of specialised outdoor equipment (the Seniors Exercise Park) supported by promotion and community capacity building activities in 6 municipalities in Victoria.
The ENJOY MAP for HEALTH incorporates 4 stages at each participating site with several strategies embedded to ‘activate a site’ to enable positive effects on physical activity behavior and sustainability including: promotion and marketing, capacity building, and development of resources.
EQUIPMENT INSTALLATION - Seniors Exercise Park
The exercise park equipment is outdoor playground equipment specifically designed for older people to improve strength, balance, joint movements and mobility and function. It comprises multiple equipment stations that target specific function or movement (upper and lower limb) such as shoulder range of movement, static and dynamic balance, functional movement of walking up/down stairs, sit to stand. The equipment will be installed in pre-determined suitable locations (e.g., part of the councils park/site upgrade (refurbishment) plan). There will be variation between sites around the overall site size, surrounding areas and amenities, and the additional play equipment.
SITE ACTIVATION -promotion and marketing, capacity building, and development of resources
1) Marketing and promotion
All project's stages will be enhanced by ongoing communication and branding strategies and activities which will maximise visibility and promotion of the Seniors exercise Park. The branding strategy will include the design of promotional material to be distributed in online and off line channels such as digital (Facebook, Instagram, website) and physical promotion (banner, posters, flyers) platforms. In addition an online app (ENJOY-ME-APP) will also be designed that include videos resources and information on how to use the equipment.
2) Capacity building - upskilling and training– knowledge transfer
Community capacity building activities will include: (a) training modules, and (b) Community health care engagement.
2a) Training modules will include training for Allied Health Professionals (Training workshops) and Senior Champions (Train the Trainer).
Allied Health Professional training will include a half day workshop incorporating theoretical component about risk management and exercise prescription and a practical session using the outdoor exercise equipment.
Train the trainer module will include twice weekly training sessions for 5 weeks as follows: 9 practical training sessions using the seniors exercise park (1.5 hours duration incorporating interactive teaching with hands-on demonstrations) and final theoretical session for 3 hours incorporating risk managements, physical activity and healthy lifestyle tips. Adherence will be monitored using participation log.
2b) Community health care engagement will include the development of relationship with local health care/leisure providers via the involvement of various project stages such as in training, project’s meetings, and community events.

Intervention code [1] 318840 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325431 0
Evaluation of usage and visitations will include periodic observation (using 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] 325431 0
At baseline (prior to installation of the Seniors Exercise Park), one month after site is open for public (after construction completion), 12 months follow up
Secondary outcome [1] 387928 0
Face-to-face intercept surveys of visitors. The intercept survey includes set of questions about socio-economic and demographic characteristics of park users.
Timepoint [1] 387928 0
At baseline and 12 months follow up
Secondary outcome [2] 387941 0
Self-reported physical activity - will be measured using three questions from the Active Australia Survey
Timepoint [2] 387941 0
At baseline (prior to installation of the Seniors Exercise Park), one month after site is open for public (after construction completion), 12 months follow up
Secondary outcome [3] 387942 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 [3] 387942 0
At baseline (prior to installation of the Seniors Exercise Park), one month after site is open for public (after construction completion), 12 months follow up
Secondary outcome [4] 387943 0
An innovative e-monitor tracker platform (online application for iOS and Android apps - (‘ENJOY-ME-APP’)) using QR codes installed on the equipment will be used to monitor the usage and access of the Senior Exercise Park by visitors at each site. The e-monitor tracker platform will collect information of usage of the online platform such as frequency, time and date based on the scanned QR codes available at the site.
Timepoint [4] 387943 0
On going from when the site is open for public for 12 months.
Secondary outcome [5] 387944 0
Review and audit of physical activity programs - information about the type and number of physical activity programs for older people using the Seniors Exercise Park will be collected from the council/leisure/health care centers
Timepoint [5] 387944 0
Between 12 - 16 months from baseline

Eligibility
Key inclusion criteria
For the face-to-face intercept survey, the following inclusion criteria will be applied: (1) older adults age 60 and over, (2) adults who are able to understand basic English and have conversational English.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) participants/park visitors who identify themselves as less than 60 years of age and (2) who are unable to understand basic conversational English.

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 natural quasi-experimental project design with before and after evaluation of the effects of age-friendly outdoor spaces on physical activity and health of older people.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics will be used to report the overall park observation visitors, visitors’ characteristics, prevalence of usage of the Seniors Exercise Park, the type and level of physical activity of visitors (SOPARC). Descriptive statistics will also be used for the intercept surveys data to collate information about visitors’ perceptions about the park, motivation to use it, social connectedness/engagement with other at the park, their physical activity level and general wellbeing and their leisure/recreation activity at the park.

A generalised linear model will be used to examine the effects of park refurbishment (equipment installation and site activation) on the total number of older people observed in the park, and the number of people walking and being physically active in the park. The linear predictor will include terms for the intervention effect, the site effects, and seasonal effects; and overdispersion will be handled by using a quasipoisson family. Statistical analyses will conducted using IMB SPSS Statistics version 26 (IBM Corporation, Armonk, NY, USA) and R.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/09/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
228
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306967 0
Charities/Societies/Foundations
Name [1] 306967 0
State Trustees Foundation of Australia
Country [1] 306967 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
Address PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country
Australia
Secondary sponsor category [1] 307530 0
None
Name [1] 307530 0
Address [1] 307530 0
Country [1] 307530 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307101 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 307101 0
Ethics committee country [1] 307101 0
Australia
Date submitted for ethics approval [1] 307101 0
14/08/2020
Approval date [1] 307101 0
26/08/2020
Ethics approval number [1] 307101 0
25499

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

Contacts
Principal investigator
Name 106038 0
Prof Pazit Levinger
Address 106038 0
Prof Pazit Levinger
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 106038 0
Australia
Phone 106038 0
+61383872626
Fax 106038 0
Email 106038 0
[email protected]
Contact person for public queries
Name 106039 0
Pazit Levinger
Address 106039 0
Prof Pazit Levinger
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 106039 0
Australia
Phone 106039 0
+61383872626
Fax 106039 0
Email 106039 0
[email protected]
Contact person for scientific queries
Name 106040 0
Pazit Levinger
Address 106040 0
Prof Pazit Levinger
PO Box 2127, Royal Melbourne Hospital, Victoria 3050 Australia
Country 106040 0
Australia
Phone 106040 0
+61383872626
Fax 106040 0
Email 106040 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
9476Study protocolA protocol paper will be submitted for publication. Once it has been accepted we will update the information on the registry  



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.