Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001064796
Ethics application status
Approved
Date submitted
30/06/2022
Date registered
1/08/2022
Date last updated
21/09/2023
Date data sharing statement initially provided
1/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A feasibility study comparing online running education to basic training advice on motivation and psychological factors for long-term running participation
Scientific title
A feasibility study comparing online running education to basic training advice on motivation and psychological factors for long-term running participation in novice runners
Secondary ID [1] 307221 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 326454 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323730 323730 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project will investigate the effect of an online running intervention on motivational and psychological factors related to running maintenance. Participants will be asked to participate in a 12-week online research study receiving either condensed or extended education relevant to running activity (education involves no face-to-face delivery). The online education will address topics known to influence exercise participation including promoting intrinsic motivation, satisfaction of basic psychological needs, intentions, and improved self-efficacy. For example, participants will be encouraged to set running goals and create habits to support their running goals. The educational content will be developed in consultation with runners, running experts, coaches and exercise physiologists. The content will include short videos (3-10 minutes in length) hosted via Panopto and activities that participants will be encouraged to watch and complete. Activities include planning their running activity for the week/s ahead or listening to a podcast. It is estimated to take approximately 15-30 minutes to complete each module (videos and activities) per week. The education and materials will be hosted by an external Moodle site hosted by the University of South Australia.

Participants will be randomized to either a control group, where they receive basic advice only (‘condensed education’) for 2 weeks, or to an intervention group, where they receive the basic advice (first two weeks) and continuing, weekly education from week two to week 12. Participants can access these in their own time. Control participants will receive the basic advice (‘condensed education’) related to running (e.g. training principles, physical activity guidelines). This will be provided during the first 2 weeks of their participation, after which no new education will be available.
Intervention code [1] 323921 0
Behaviour
Comparator / control treatment
Control participants will receive basic advice (‘condensed education’) related to running (e.g. training principles, physical activity guidelines) for 2 weeks. This will be provided during the first 2 weeks of their participation, after which no new education will be available. Intervention adherence will be reported based on the proportion of participants accessing the online education and calculating the percentage and duration of video content watched through data derived from Panopto analytics on the Moodle site.
Control group
Active

Outcomes
Primary outcome [1] 331860 0
Participant eligibility: participant eligibility rate assessed by audit of study records
Timepoint [1] 331860 0
Timepoint: after completion of rolling recruitment
Primary outcome [2] 331861 0
Intervention adherence: intervention adherence assessed by website analytics
Timepoint [2] 331861 0
Timepoint: once all participants have completed follow up (3 months post-intervention)
Primary outcome [3] 331862 0
Primary outcome 3: acceptability of secondary outcome measured by proportion of participants who respond to the questionnaires
Timepoint [3] 331862 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [1] 411407 0
Secondary outcome 1: motivation towards running (Behavioural Regulation in Exercise Questionnaire [BREQ-3])
Timepoint [1] 411407 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [2] 411408 0
Secondary outcome 2: basic psychological needs (Basic Psychological Needs in Exercise Scale [BPNES])
Timepoint [2] 411408 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [3] 411409 0
Intentions (6 purpose-built Likert-scale questions e.g. "in the next 6 weeks, I intend to [increase, maintain, decrease] the time I spend running")
Timepoint [3] 411409 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [4] 411410 0
Secondary outcome 4: self-efficacy (Multidimensional Self-Efficacy Scale [MSES])
Timepoint [4] 411410 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [5] 411411 0
Secondary outcome 5: wellbeing (12-item Short Form Survey [SF-12])
Timepoint [5] 411411 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [6] 411412 0
Secondary outcome 6: barriers/benefits of running assessed as a composite outcome using a modified Exercise Benefits/Barriers Scale (EBBS)
Timepoint [6] 411412 0
Timepoint: Baseline, Week 6, Week 12 and Follow-up (3-months post-intervention completion)
Secondary outcome [7] 412360 0
Recruitment rate assessed by audit of study records
Timepoint [7] 412360 0
Timepoint: after completion of rolling recruitment
Secondary outcome [8] 412361 0
Losses to follow-up: Number of dropouts with their stated reasons will be collected via audit of study records for both groups (e.g. injury, no longer performing running activity, prefer not to say)
Timepoint [8] 412361 0
Timepoint: completion of all data collection
Secondary outcome [9] 412364 0
User-experience will be assessed with purpose-built questions and rated using a 6-item Likert scale (strongly disagree to strongly agree) for questions such as "the structure of the modules of the modules were presented and linked in a logical way"
Timepoint [9] 412364 0
Timepoint: at 3-month Follow-up (3-months post-intervention)

Eligibility
Key inclusion criteria
- Aged 18 – 64 years old
- Previously ran as a form of regular physical activity or interested in starting to run or currently running but with less than 3 months of running experience
- Own a GPS smartphone and/or a smartwatch capable of tracking basic running metrics
- Willing to use a running activity application (Strava) to upload running activity and allow the primary researcher to follow your profile to track running activity
- Are not currently injured or undergoing rehab for an injury which may make it difficult to run
- Have no known medical conditions which may heighten the risk of adverse event due to running or receive GP clearance to be involved
- Have regular internet access
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they have a medical condition or injury that restricts them from running, have a running coach or currently follow a guided running training program (e.g. Couch to 5K).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed-envelope: professional online randomisation tool
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple 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 receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data analyses will be performed using IBM SPSS Statistics 27 (IBM Corporation, Armonk, NY). Baseline characteristics of participants will be graphically examined using histograms and descriptive statistics (means, standard deviation, medians and ranges) as indicated by normality tests. An intention-to-treat approach will be followed. Multiple imputation will be used to handle missing data, with the final approach guided by a statistician within the academic unit. ANCOVA will be used to compare psychological variables (motivation, basic psychological needs, self-efficacy, intentions) between the intervention and control groups (independent variable) at 12-weeks with baseline scores entered as a covariate. Training metric data will be plotted to check the distributions and identify any potential outliers that may indicate an error in the data collection process by participants. Magnitude of change will be expressed with effect sizes and 95% confidence intervals. Discontinuation rates will be compared between groups using relative risk with 95% confidence intervals. Normality testing will be performed to determine the need for non-parametric statistical approaches to be used. Statistical significance will be set at p<.05. Results will be reported in line with the CONSORT statement and the intervention reported as per the TIDier guidelines.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/07/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
4/09/2022
Date of last data collection
Anticipated
31/03/2023
Actual
31/01/2023
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311517 0
University
Name [1] 311517 0
University of South Australia
Country [1] 311517 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
Level 8 Centenary Building, City East campus, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 313425 0
None
Name [1] 313425 0
None
Address [1] 313425 0
None
Country [1] 313425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310978 0
University of South Australia's Human Research Ethics Committee
Ethics committee address [1] 310978 0
Ethics committee country [1] 310978 0
Australia
Date submitted for ethics approval [1] 310978 0
17/05/2021
Approval date [1] 310978 0
19/01/2022
Ethics approval number [1] 310978 0
203978

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

Contacts
Principal investigator
Name 119566 0
Dr John Arnold
Address 119566 0
UniSA Allied Health and Human Performance
Level 8 Centenary Building, City East campus
Corner of North Terrace and Frome Road
Adelaide SA 5001
Country 119566 0
Australia
Phone 119566 0
+61 8 830 21329
Fax 119566 0
Email 119566 0
[email protected]
Contact person for public queries
Name 119567 0
Chloe Blacket
Address 119567 0
UniSA Allied Health and Human Performance
Level 8 Centenary Building, City East campus
Corner of North Terrace and Frome Road
Adelaide SA 5001
Country 119567 0
Australia
Phone 119567 0
+61 468575388
Fax 119567 0
Email 119567 0
[email protected]
Contact person for scientific queries
Name 119568 0
Chloe Blacket
Address 119568 0
UniSA Allied Health and Human Performance
Level 8 Centenary Building, City East campus
Corner of North Terrace and Frome Road
Adelaide SA 5001
Country 119568 0
Australia
Phone 119568 0
+61 468575388
Fax 119568 0
Email 119568 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 - IPD will not be available. Individual participant data not shared.


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.