Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624000261516p
Ethics application status
Submitted, not yet approved
Date submitted
18/05/2023
Date registered
15/03/2024
Date last updated
23/05/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Targeting engagement in resistance training in the community using outdoor gyms: A study protocol for 'scaling-up' the ecofit intervention
Scientific title
Targeting engagement in resistance training in the community using outdoor gyms: A study protocol for the ecofit type III hybrid effectiveness-implementation trial
Secondary ID [1] 309666 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 330008 0
sedentary behaviour 332740 0
overweight/obesity 332741 0
Condition category
Condition code
Public Health 326915 326915 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ecofit is a community-based multi-component resistance and aerobic-based physical activity intervention with established efficacy in adults at risk of/diagnosed with Type 2 diabetes, and effectiveness in community-dwelling adults failing to satisfy physical activity recommendations. This implementation study will outline the steps in guiding the translation pathway of ecofit to larger scale implementation using two different implementation support models: (i) Low support (i.e., ecofit app/website) versus (ii) Moderate support (i.e., ecofit app/website + QR codes + face-to-face workout sessions). To clarify, the introductory workout sessions are not an intervention component but an implementation strategy. The intervention itself is receiving the ecofit app, which users can use as much as they wish. The length of the implementation period is 6-months

For the moderate support model: The workout sessions will be supervised/run by an Exercise professional (e.g., personal trainer, exercise physiologist) and will be conducted at outdoors at the outdoor gyms, which have been randomised to the intervention group. Each outdoor gym will receive 3 sessions in the second month of the trial and will last for approx 60 minutes. These are introductory sessions to using the outdoor gyms to workout. The Exercise professional will guide attendees through exercises that are of beginner/entry level; these are considered low-moderate intensity. No strategies will be used to assess adherence as it's optional to attend, however, count data will be collected to see how many people attend each session. Examples of exercises include sit to stand, push up against a high bar, seated lean and hold, supported leg raises. The QR codes is linked to the ecofit platform i.e., if a person scans the QR code, they will be directed to the ecofit website where they get instructed on how they can download the app/sign up.

As the randomisation occurs on a park level, only parks randomised to the moderate support strategies will receive the additional support strategies (i.e., QR codes and face-to-face workout sessions). Individuals can attend whichever park they chose to, but they will not know that some parks are intervention versus control parks. The app is free to anyone to use, so all individuals can download it. For those who download the app, they will have access to workouts that guide them through exercises using the outdoor gym equipment. They also have access to introductory material e.g., an app manual and brief video (2 min) explaining how to use the app. It is up to participants’ own discretion to use the app as much or as little as they like. Given the last point, there are no strategies to monitor adherence, however, we will collect data on app usage.
Intervention code [1] 326098 0
Lifestyle
Intervention code [2] 326099 0
Behaviour
Comparator / control treatment
Control group will be parks (not people). Each outdoor workout location will be pair-matched (high versus low), based on an established socio economic status consensus-based index ( i.e., the Socio-Economic Indexes for Areas index of relative socio-economic disadvantage) of the area the park is located in. Parks within each pair will then be randomised to one of the two conditions (i.e., ’Low’ or ‘Moderate’ implementation support). The control parks will be included in the ecofit smartphone app, however, there will be no face-to-face support in the parks and no QR codes. App users can find the control parks in the app
Control group
Active

Outcomes
Primary outcome [1] 334753 0
Reach: The primary outcome ‘reach’ is defined as the difference in the absolute number of outdoor gym users (i.e., using the outdoor gyms for intended purposes) between the two implementation models. Reach will also be evaluated by comparing the proportion of individuals using the outdoor gyms for intended purposes (i.e., to workout), compared to non-intended purposes (e.g., sitting or playing on the equipment) and moving past the equipment without interacting with the facilities. These will be measured using the System for Observing Play and Recreation in Communities - Resistance training (SOPARC-RT). We have modified the original measure to include specific measures on resistance training
Timepoint [1] 334753 0
Will be measured at baseline and at 3-months post baseline
Secondary outcome [1] 421953 0
Uptake: ‘Uptake’ will be defined as the total number of app registrations. Only app registrations from the Newcastle and Lake Macquarie municipalities (i.e., based on postcode) and from the launch date of the promotional campaign will be included in the analysis. ‘Uptake’ will also be evaluated by the proportion of participants who register an account and log at least one workout in the app, and by the number of people attending the face-to-face workout sessions in the parks receiving Moderate implementation support. The fitness professionals conducting the park-based face-to-face workout sessions will collect count data on attendees.
Data will be collected using app analytics and using count data (where applicable)
Timepoint [1] 421953 0
App registrations will be measured at 3- and 6-months post rollout of of implementation models. Number of people attending the face to face sessions will be measured using count data for each session within the intervention period.
Secondary outcome [2] 421954 0
Dose received (exposure): ‘Dose received (exposure)’ will be evaluated by the proportion of participants logging at least one workout in the app over a 3- and 6-month time-period (i.e., 6-months from registering the app). Dose received (exposure) will also be assessed by the average number of workouts completed amongst participants logging at least one workout in the app over a 3- and 6-month time-period. Data relating to additional characteristics of dose received will also be evaluated, which include (i) changes in the workout difficulty over the 3- and 6-month time-period by individuals, (ii) assessment of whether app users engage in different workout types and visits different outdoor gym locations, and (iii) evaluation of the number of workout video views in the app, and the number of app manual views/downloads and video views on the website. Data will be collected using app analytics and google analytics (where applicable)
Timepoint [2] 421954 0
This will be measured at 3- and 6-months post rollout of implementation models.
Secondary outcome [3] 421955 0
Impact: ‘Impact’ outcomes will be collected via the built-in self-assessment in the ecofit app. App users will conduct and enter their own self-assessed upper (i.e., push ups on toes or knees) and lower body (i.e., 60-s sit-to-stand test) muscular fitness. The push-up and 60-s sit-to-stand tests have been demonstrated strong and moderate validity in a sample of community dwelling adults, respectively.
Timepoint [3] 421955 0
At baseline (when app users initially register) and 6-months post-rollout of implementation models
Secondary outcome [4] 421956 0
Fidelity: A member of the research team will randomly observe each fitness professional on at least two occasions to assess how the individual conducted the workout sessions at the ecofit plus parks.
Timepoint [4] 421956 0
Will be measured after the 3-months post-rollout of implementation models when all sessions have been conducted.
Secondary outcome [5] 421957 0
Acceptability: All fitness professionals will be interviewed at the conclusion of all workout sessions and perceptions about acceptability delivering the workout sessions will be explored using a survey specifically designed for this study. Acceptability will also be evaluated evaluated with a survey among participants who have engaged in at least one face-to-face workout session. The participant survey will be administered via the app using a survey that was specifically designed for this study.
Timepoint [5] 421957 0
Will be measured after the 3-months post-rollout of implementation models when all sessions have been conducted.
Secondary outcome [6] 421958 0
Cost-effectiveness: We will conduct a cost-effectiveness analysis by calculating the resources spent on design, adaption and implementation of the two implementation strategies using an audit of study records (e.g., running the workout sessions, printing QR codes etc).
Timepoint [6] 421958 0
Will be measured after the 6-months post-rollout of implementation models
Secondary outcome [7] 431434 0
Feasibility: All fitness professionals will be interviewed at the conclusion of all workout sessions. Perceptions about feasibility delivering the workout sessions will be explored. Questions specifically used for this study will be used.
Timepoint [7] 431434 0
Will be measured after the 3-months post-rollout of implementation models when all sessions have been conducted.
Secondary outcome [8] 431435 0
Satisfaction: All fitness professionals will be interviewed at the conclusion of all workout sessions and perceptions about satisfaction delivering the workout sessions will be explored using a survey specifically designed for this study. Satisfaction will also be evaluated evaluated with a survey among participants who have engaged in at least one face-to-face workout session. The participant survey will be administered via the app using a survey that was specifically designed for this study.
Timepoint [8] 431435 0
Will be measured after the 3-months post-rollout of implementation models when all sessions have been conducted.

Eligibility
Key inclusion criteria
Not applicable for participant. The app is downloadable for anyone, but only app data from participants aged 18 years and over will be used in the analysis

Only locations with outdoor gym equipment were included in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
NA

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Pair-matched (as explained below) randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical analyses of the primary (i.e., reach) and secondary (except from fidelity) outcomes will be conducted with generalized linear models adjusted for the baseline value of the outcome using IBM SPSS Statistics version 30 (IBM Corporation, Armonk, NY) for Windows computers. These models will include fixed effect for study group, baseline value of the outcome, stratification variables (i.e., high versus low SEIFA value). Additional exploratory sub-group analyses of the intervention effect on the primary (i.e., reach) and secondary outcomes (i.e., uptake, dose received, usage and impact) will be conducted using generalized linear models adjusted for the baseline value of the outcome (i.e., group-by-moderator) by sex (i.e., male, female, unsure) and age (i.e., children [0-12 years], adolescents [13-20 years], adults [21-59 years], and seniors [60 years or older]). Descriptive statistics will be used to examine a further secondary outcome of the study (i.e., fidelity) and the implementation determinants (i.e., acceptability, feasibility, dose satisfaction and cost). We will also provide descriptive information of all the included outdoor gym locations i.e., number of pieces of equipment, quality of equipment and type of outdoor gym (i.e., trail, pod, pod/trail). Analysis of app usage data will include descriptive statistics and Cox Regression to examine time to non-usage attrition as in prior studies.

We randomise on a park-level i.e., 16 parks will be included in this study. The below effect size is based on individuals observed in these parks.
To detect a Cohen’s d of 1 (strong effect) , we estimate that ~2 individuals will be observed using the outdoor gyms as intended per day per park (17 individuals in total in each group per day) assuming 80% power and p = 0.05. Taking clustering by park into consideration and assuming an ICC of 0.05, then the design effect is 1.05, resulting in ~3 individuals per day/park (24 individuals in total in each intervention group, total n=48). From our previous work, this number is reasonable to expect (40).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313859 0
Government body
Name [1] 313859 0
National Health and Medical Research Council
Country [1] 313859 0
Australia
Primary sponsor type
Hospital
Name
University of Newcastle
Address
University Drive, Callaghan, NSW, 2308
Country
Australia
Secondary sponsor category [1] 315718 0
None
Name [1] 315718 0
Address [1] 315718 0
Country [1] 315718 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313005 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 313005 0
Ethics committee country [1] 313005 0
Australia
Date submitted for ethics approval [1] 313005 0
04/04/2023
Approval date [1] 313005 0
Ethics approval number [1] 313005 0

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

Contacts
Principal investigator
Name 126658 0
Prof Ronald Plotnikoff
Address 126658 0
ATC building Level 3, 1 University drive, University of Newcastle, Callaghan, 2308, NSW
Country 126658 0
Australia
Phone 126658 0
+61 249854465
Fax 126658 0
Email 126658 0
[email protected]
Contact person for public queries
Name 126659 0
Ronald Plotnikoff
Address 126659 0
ATC building Level 3, 1 University drive, University of Newcastle, Callaghan, 2308, NSW
Country 126659 0
Australia
Phone 126659 0
+61 249854465
Fax 126659 0
Email 126659 0
[email protected]
Contact person for scientific queries
Name 126660 0
Ronald Plotnikoff
Address 126660 0
ATC building Level 3, 1 University drive, University of Newcastle, Callaghan, 2308, NSW
Country 126660 0
Australia
Phone 126660 0
+61 249854465
Fax 126660 0
Email 126660 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?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
Any analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof Ronald Plotnikoff, [email protected])


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.