Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000326695
Ethics application status
Approved
Date submitted
8/03/2023
Date registered
28/03/2023
Date last updated
28/03/2023
Date data sharing statement initially provided
28/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of an online team-based step tournament to promote active ageing
Scientific title
The effectiveness, engagement, usability and acceptability of a web-based team step tournament to promote active ageing
Secondary ID [1] 309109 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
heart disease 329192 0
diabetes 329193 0
cancer 329194 0
cognitive decline 329195 0
osteoporosis 329197 0
Inactivity 329198 0
Condition category
Condition code
Public Health 326157 326157 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned in clusters to intervention group (tournament 1) or waitlist control group (tournament 2). The 10,000 steps team tournament will involve community group team members syncing their tracker recorded steps on the 10,000 steps website to compete with other community groups on average team steps over a 6-week period. Each team will be coordinated throughout the tournament by the project staff who will send tournament updates via email weekly (e.g. leaderboard updates and time left in tournament). Physical activity information (e.g. Australian physical activity guidelines for older adults- 30 minutes on most days) and behavior change information (benefits and barriers, goal setting, environment, habit formation) will also be emailed weekly and participants will be encouraged to engage in a moderated online social networking group specific to their tournament. The time to read the email content, sync steps with the 10,000 steps website and check team progress is likely to be less than 20 minutes a week. However, the time to participate in physical activity could be 30 minutes or more per day depending on participants’ baseline physical activity and tournament goals. Adherence to the intervention will be recorded by website usage statistics (i.e., time on site, number of log ins, number of days steps synced) and activity in the social media forum (i.e., comments, likes). Prior to the tournament and following the tournament participants will have access to the general 10,000 steps website where they can sync and track their steps individually. They will be able to view their team tournament leader board and access physical activity information, but they will not receive tournament updates or physical activity behaviour change emails. Following the end of the trial they will continue to have access until they de-activate their account.
Intervention code [1] 325556 0
Behaviour
Intervention code [2] 325557 0
Prevention
Comparator / control treatment
The control group will receive individual access to the 10,000 steps website. They will sync and track their steps on the website, but they will not receive tournament updates or physical activity behaviour change emails. The control group will be offered the intervention (i.e. team tournament 2) in week 10 of the trial.
Control group
Active

Outcomes
Primary outcome [1] 334028 0
Steps (average per day over previous 7 days) recorded by activity tracker.
Timepoint [1] 334028 0
In week 9 (post-tournament) survey participants will enter their average steps per day from the last 7 days.
Secondary outcome [1] 419126 0
Moderate to vigorous physical activity via the Active Australia Survey (AAS)
Timepoint [1] 419126 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [2] 419226 0
Active minutes (average per day over previous 7 days) recorded by activity tracker.
Timepoint [2] 419226 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [3] 419227 0
Sleep minutes (average per day over previous 7 days) recorded by activity tracker.
Timepoint [3] 419227 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [4] 419228 0
General social support (Duke Social Support Index).
Timepoint [4] 419228 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [5] 419229 0
Steps (average per day over previous 7 days) recorded by activity tracker.
Timepoint [5] 419229 0
Week 16 (post-tournament 2) survey
Secondary outcome [6] 419230 0
Quality of Life (SF-12)
Timepoint [6] 419230 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [7] 419231 0
Website usability (System Usability Scale)
Timepoint [7] 419231 0
Week 9 (post-tournament 1) for intervention group and week 16 (post-tournament 2) for wait-list group only
Secondary outcome [8] 419232 0
Program acceptability (18 multiple choice and 11 open ended questions based on past research)
Timepoint [8] 419232 0
Week 9 (post-tournament 1) for intervention group and week 16 (post-tournament 2) for wait-list group only
Secondary outcome [9] 419233 0
Time on site (minutes spent on the 10,000 steps website recorded by website analytics)
Timepoint [9] 419233 0
Time on site will be automatically recorded throughout the entire 16-week trial
Secondary outcome [10] 419799 0
Physical activity specific social support (Social support and exercise survey)
Timepoint [10] 419799 0
Week 9 (post-tournament 1) survey and week 16 (post-tournament 2) survey
Secondary outcome [11] 419800 0
Site visits (number of visits to the 10,000 steps website recorded by website analytics).
Timepoint [11] 419800 0
Number of site visits will be automatically recorded throughout the entire 16-week trial
Secondary outcome [12] 419801 0
Days steps synced (number of days steps synced to the 10,000 steps website recorded by website analytics)
Timepoint [12] 419801 0
Days steps synced will be automatically recorded throughout the entire 16-week trial
Secondary outcome [13] 419802 0
Engagement with social media group (number of posts, likes, comments downloaded from Facebook)
Timepoint [13] 419802 0
Throughout the 6 week team tournament
Secondary outcome [14] 419803 0
Social media group content analysis (qualitative content analysis of posts and comments downloaded from Facebook)
Timepoint [14] 419803 0
Throughout the 6 week team tournament

Eligibility
Key inclusion criteria
Participants will be community dwelling, English speaking adults who have Internet access, reside in Australia and can safely increase their physical activtiy. Participants will be recruited through local community organizations (Men’s Shed, Probus, and U3A) and groups (clubs, churches). We are aiming to recruit older adults to promote active ageing but anyone over the age of 18 is eligible to participate if invited to join a team.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they live in a care facility, do not speak English, do not have internet access, do not reside in Australia, or are deemed at health risk when increasing physical activity (i.e., screened at risk by the Physical Activity Readiness Questionnaire and no doctors approval).

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed model analysis will be conducted to compare the two groups (tournament vs waitlist) on step changes between week 2 and 9. Linear mixed model analyses will also be conducted to compare the two groups (tournament vs waitlist) on secondary outcomes (incl. tracker recorded active minutes, self-reported MVPA, sleep, Quality of Life, Social Support) between week 2, 9 and 16. A fixed effect for group and time and a random intercept for participants will be included. Generalized linear models will be conducted to compare groups (tournament vs waitlist) on time on site, number of log ins, and number of days steps logged. Non usage attrition will be displayed for each group through Kaplan-Meier survival curves and will be compared via a log rank test. Participant engagement in Facebook group will be reported and a qualitative content analysis of comments on the Facebook group will be conducted.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313312 0
Charities/Societies/Foundations
Name [1] 313312 0
National Heart Foundation
Country [1] 313312 0
Australia
Funding source category [2] 313333 0
University
Name [2] 313333 0
Central Queensland University
Country [2] 313333 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
554-700 Yaamba Rd, Norman Gardens QLD 4701
Country
Australia
Secondary sponsor category [1] 315054 0
Individual
Name [1] 315054 0
Stephanie Alley
Address [1] 315054 0
Building 7, Bruce Hwy, Central Queensland University, Bruce Hwy, Rockhampton, QLD, 4701
Country [1] 315054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312536 0
Central Queensland University Human Ethics Commitee
Ethics committee address [1] 312536 0
554-700 Yaamba Rd, Norman Gardens QLD 4701
Ethics committee country [1] 312536 0
Australia
Date submitted for ethics approval [1] 312536 0
13/02/2023
Approval date [1] 312536 0
16/03/2023
Ethics approval number [1] 312536 0
23917

Summary
Brief summary
The study aims to test the acceptability, engagement and physical activity changes of a web-based physical activity program utilizing social support to promote active ageing. The study will be a cluster randomized trial of a 10,000 steps tournament in older adults. The 10,000 steps team tournament will involve community group team members syncing their tracker recorded steps on the 10,000 steps website to compete with other community groups on average team steps over a 6-week period. Each team will be coordinated throughout the tournament by the project staff who will send tournament updates weekly (e.g. leaderboard updates and time left in tournament). Physical activity information (e.g. physical activity guidelines for older adults) and behavior change information (benefits and barriers, goal setting, environment, habit formation) will also be emailed weekly and participants will be encouraged to engage in a moderated online social networking group specific to their tournament. Local community groups with members predominantly 55+ years will be randomly assigned to the intervention group (tournament 1) or the waitlist group (tournament 2). Individuals will sign up to their local groups' team. At week 1 of the trial participants will be asked to start recording their steps through an activity tracker, then complete a brief online baseline survey at week 2 to assess participant demographics, tracker recorded and self-reported physical activity and social support. Teams in the intervention group will complete their 6-week step tournament between week 3 and 8. During this time wait list group participants will have individual access to the 10,000 steps website. Both groups will complete a brief post-intervention online survey in week 9 to assess intervention acceptability (intervention group only) and reassess physical activity and social support. Participants in the wait list condition will complete their tournament between week 10 and 15. During this time intervention group participants will have individual access to the 10,000 steps website. Both groups will compete a follow up online survey in week 16 to assess intervention acceptability (wait-list group only) and reassess physical activity and social support. Intervention engagement (e.g. log ins, days steps synced, time on website) will be recorded via the 10,000 steps website throughout the 16 week trial. Primary outcome will be between group (tournament vs waitlist) differences on step changes between week 2 and 9.
Trial website
https://www.10000steps.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125014 0
Dr Stephanie Alley
Address 125014 0
Building 7, Central Queensland University, Bruce Hwy, Rockhampton North, 4700, QLD
Country 125014 0
Australia
Phone 125014 0
+61749232263
Fax 125014 0
Email 125014 0
s.alley@cqu.edu.au
Contact person for public queries
Name 125015 0
Dr Stephanie Alley
Address 125015 0
Building 7, Central Queensland University, Bruce Hwy, Rockhampton North, 4700, QLD
Country 125015 0
Australia
Phone 125015 0
+61749232263
Fax 125015 0
Email 125015 0
activecommunity@cqu.edu.au
Contact person for scientific queries
Name 125016 0
Dr Stephanie Alley
Address 125016 0
Building 7, Central Queensland University, Bruce Hwy, Rockhampton North, 4700, QLD
Country 125016 0
Australia
Phone 125016 0
+61749232263
Fax 125016 0
Email 125016 0
s.alley@cqu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified project data underlying published results only, specifically participant survey data and program statistics (step counts and website usage).
When will data be available (start and end dates)?
After completion of data collection (January 2024). Then ongoing (no end date).
Available to whom?
Anyone
Available for what types of analyses?
Quantitative evaluation analyses
How or where can data be obtained?
It will be shared in an online registry (e.g. Figshare or Dryad)


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.