Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000458730
Ethics application status
Approved
Date submitted
4/03/2022
Date registered
23/03/2022
Date last updated
17/05/2023
Date data sharing statement initially provided
23/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of an evidence-based educational module about running shoes on footwear selection, comfort and satisfaction: a randomised controlled trial.
Scientific title
The influence of an evidence-based educational module about running shoes on footwear selection, comfort and satisfaction in adult road runners: a randomised controlled trial.
Secondary ID [1] 306125 0
None
Universal Trial Number (UTN)
U1111-1272-8244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Running-related injuries 325462 0
Condition category
Condition code
Injuries and Accidents 322280 322280 0 0
Other injuries and accidents
Musculoskeletal 323061 323061 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
How does an educational module influence running shoe selection, satisfaction, and comfort over time in road runners?

Subjects in the intervention group will be assigned an educational module that is to be viewed before the purchase of their new running shoes. The educational module will present the latest scientific evidence related to selecting running footwear and is adapted specifically for this study from published research (http://dx.doi.org/10.1136/bmjsem-2020-000767). The module identifies research on running footwear and its relationship to running injury. The intervention group will receive only one module during the experiment, which should last approximately 10 minutes. All modules will be delivered via a graphical/video presentation based on Microsoft PowerPoint to be viewed online, with potential for interactive components. Interactions may include clicking on portions of the presentation in order to continue progress. After completing the assigned module, runners will be instructed to purchase a running shoe within a month for the primary purpose of road running. Runners will be contacted via phone and/or email after the module to assess completion. Running volume and intensity will be left up to participant discretion for the duration of the study, although runners will be encouraged to continue their normal training schedule. Runners will report training volume as part of their surveys. Following the completion of the purchase, runners will participate in online surveys via Qualtrics at three time points (before 1st use, 1 month, 3 months). Runners will be asked to provide proof of purchase via receipt. The survey questions are to be completed online and address shoe selection, comfort, and satisfaction, as well as running-related injuries.

We intend to ask participants which group they thought they were in at the end of the experiment to assess how effective the blinding was.

'Which group do you think you were allocated to (intervention or control)? Why do you feel that way?'
Intervention code [1] 322551 0
Behaviour
Comparator / control treatment
Subjects in the control group will be assigned an informational module related to running history and participation as a "sham intervention". It is modeled based on the intervention group educational module in terms of duration and style. The module should take approximately 10 minutes and will be viewed only once, prior to shoe purchase. Informational modules will be presented using PowerPoint, and may have video and interactive components. Interactions may include clicking on portions of the presentation in order to continue progress. Runners in the control group will be asked to maintain their normal training schedule, and are asked to report volume in follow-up surveys. Runners will be asked to provide proof of purchase via receipt. Runners will be contacted via phone and/or email after the module to assess completion.
Control group
Placebo

Outcomes
Primary outcome [1] 330229 0
One primary outcome is to identify how comfort differs between the control (sham module) group and the experimental (evidence-based educational module) group. Comfort will be assessed using a 0-100 mm visual analogue scale (Matthias et al., 2021), where 0 mm means 'extremely uncomfortable,' and 100 mm means 'extremely comfortable.'
Timepoint [1] 330229 0
The primary outcome will be measured at three time points (before first use, 1 month, 3 months), although the 1 month after purchase will be considered as the primary time point for analysis purposes.
Primary outcome [2] 330230 0
A second primary outcome is to identify how satisfaction differs between the control (sham module) group and the experimental (evidence-based educational module) group. Satisfaction will be assessed using a 0-100 mm VAS, where 0 mm means 'extremely unsatisfied,' and 100 mm means 'extremely satisfied.'
Timepoint [2] 330230 0
The primary outcome will be measured at three time points (before first use, 1 month, 3 months), although the 1 month after purchase will be considered as the primary time point for analysis purposes.
Secondary outcome [1] 406288 0
Additional outcomes include whether runners experience a running-related injury during study participation, as defined by Yamato et al. (2015). Injury will be reported using a survey question with multiple choice and a visual aid to assist in injury description.
Timepoint [1] 406288 0
One month post-purchase and three months post-purchase.
Secondary outcome [2] 406289 0
The effect of the new shoes on running performance, ranked using a 0-100 mm visual analog scale, where endpoint 0 mm is 'decreased performance,' and 100 mm is 'increased performance.'
Timepoint [2] 406289 0
One month post-purchase and three months post-purchase.
Secondary outcome [3] 406290 0
The influence of the educational module on shoe selection. The study-specific survey has a question designed to address this outcome.
Timepoint [3] 406290 0
Post-purchase and before first use.

Eligibility
Key inclusion criteria
Participants will be adults aged 18 or over who met the eligibility criteria of running at least once weekly for at least one month (Dhillon et al., 2020), willing to purchase running shoes within one month of enrolment at a participating store or online, and committed to completing the follow-up surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Runners that will not primarily use their shoes for road running. Runners that are injured during enrolment or within one month prior as defined by Yamato et al 2015: Running related (training or competition) musculoskeletal pain in the lower limbs or low back that causes a restriction on or stoppage of running (distance, speed, duration, or training) for at least 7 days or 3 consecutive scheduled training sessions, or that requires the runner to consult a physician or other health professional.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is "off-site" or at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified sampling will be used to better represent the running population.
The factors that will be implemented include gender (male, female, non-binary/other), age (34 or under, 35 or older), and foot-strike pattern (rear-foot strike, mid/forefoot).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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
A sample size of 112 (56 per group) participants was calculated a priori based on achieving a power of ß = 0.90 with an a = 0.025. Note that an alpha level of 0.025 was selected instead of 0.05 to account for multiple comparisons (i.e., two main outcome measures). This calculation was based on assumptions of similar standard deviations when using a visual analogue scale to measure comfort (Hébert-Losier et al., 2020) and the meaningful change reported by Mills et al. (2010) in relation to VAS differences.
Repeated-measures ANOVAs with 2 factors (Group: Intervention/Control; Time: before 1st use, 1 month, 3 months) will be used to compare the primary and secondary outcomes, and descriptive statistics used to report participant characteristics and outcome measures (comfort, satisfaction). Group differences will be expressed in raw scores, with 95% confidence intervals and effect sizes (eta squared 0.01-small, 0.06-medium, 0.14-large). Actual values will be given (P values and effect sizes). 134 participants will be recruited to account for dropout (20%). Participants will be randomly assigned to receive either the sham intervention or educational module accounting for stratification processes.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/03/2022
Actual
18/07/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
13/12/2022
Date of last data collection
Anticipated
31/10/2022
Actual
3/05/2023
Sample size
Target
134
Accrual to date
Final
85
Recruitment outside Australia
Country [1] 24523 0
United States of America
State/province [1] 24523 0
Washington State

Funding & Sponsors
Funding source category [1] 310474 0
University
Name [1] 310474 0
University of Waikato
Country [1] 310474 0
New Zealand
Primary sponsor type
Individual
Name
Andrew Fife
Address
The University of Waikato
Te Whare Wananga o Waikato
Adams Centre for High Performance
52 Miro Street
3116 Tauranga
Country
New Zealand
Secondary sponsor category [1] 311624 0
Individual
Name [1] 311624 0
Kim Hébert-Losier
Address [1] 311624 0
The University of Waikato
Te Whare Wananga o Waikato
Adams Centre for High Performance
52 Miro Street
3116 Tauranga
Country [1] 311624 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310104 0
HECS Human Ethics Committee University of Waikato
Ethics committee address [1] 310104 0
Ethics committee country [1] 310104 0
New Zealand
Date submitted for ethics approval [1] 310104 0
29/06/2021
Approval date [1] 310104 0
05/07/2021
Ethics approval number [1] 310104 0
HREC(HECS)2021#31

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

Contacts
Principal investigator
Name 116486 0
Dr Kim Hébert-Losier
Address 116486 0
The University of Waikato
Adams Centre for High Performance
52 Miro Street
Mount Maunganio
3116 Tauranga
Country 116486 0
New Zealand
Phone 116486 0
+64 7 837 9476
Fax 116486 0
Email 116486 0
[email protected]
Contact person for public queries
Name 116487 0
Kim Hébert-Losier
Address 116487 0
The University of Waikato
Adams Centre for High Performance
52 Miro Street
Mount Maunganio
3116 Tauranga
Country 116487 0
New Zealand
Phone 116487 0
+64 7 837 9476
Fax 116487 0
Email 116487 0
[email protected]
Contact person for scientific queries
Name 116488 0
Kim Hébert-Losier
Address 116488 0
The University of Waikato
Adams Centre for High Performance
52 Miro Street
Mount Maunganio
3116 Tauranga
Country 116488 0
New Zealand
Phone 116488 0
+64 7 837 9476
Fax 116488 0
Email 116488 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?
Individual participant data related to published results only.
When will data be available (start and end dates)?
Data will be available immediately following publication; no end date determined.
Available to whom?
Researchers that have provided methodologically sound proposals will have access to the data. Others can request access in case-by-case instances at the discretion of the primary sponsor.
Available for what types of analyses?
The data will be available for use in reviews and meta-analyses (including IPD), or to achieve the aims of approved research proposals.
How or where can data be obtained?
Data will be available through a Google drive link via Principal Investigator. They can be reached at the following email address: [email protected]



What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15243Informed consent form  [email protected] 383357-(Uploaded-04-03-2022-05-32-38)-Study-related document.docx



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.