Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001500448
Ethics application status
Approved
Date submitted
26/10/2016
Date registered
28/10/2016
Date last updated
28/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
UniSA Run Free: A Facebook Running Program for healthy Australian adults
Scientific title
Effectiveness of a Facebook delivered running program for healthy Australian Adults on cardio-respiratory fitness and physical activity: A Randomised Controlled Trial
Secondary ID [1] 290277 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 300510 0
cardiorespiratory fitness 300511 0
Condition category
Condition code
Public Health 300367 300367 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
UniSA Run Free is an eight week beginners running program that has been created in collaboration with experts in the field, Dr Grant Tomkinsion and professor Kevin Norton, to ensure that the program progresses safely and in an achievable and realistic manner for beginner runners. The running program and the Facebook group is being monitored by an Occupational Therapy honours student, who is being supervised by two senior Occupational Therapists and a senior Physiotherapist. The running program itself, consists of three sessions per week, where each session includes a 5 min walk warm up and cool down. The three sessions for each of the 8 weeks is described below
Week 1: 5 sets of run 1 minute, walk 1 minute; 6 sets of run 1 minute walk 1 minute; 5 sets of run 90 seconds and walk 90 seconds
Week 2: 6 sets of run 90 seconds and walk 90 seconds; 5 sets of run 2 minutes and walk 2 minutes; 3 sets of run 3 minutes and walk 3 minutes
Week 3: 6 sets of run 2 minutes and walk 2 minutes; 6 sets of run 2 minutes and walk 1 minute, 6 sets of run 3 minutes and walk 90 seconds
Week 4: 5 sets of run 4 minutes and walk 2 minutes; 7 sets of run 3 minutes and walk 1 minute; Run 12 minutes continuously
Week 5: 6 sets of run 4 minutes and walk 2 minutes; 10 sets of run 3 minutes and walk 1 minute; 4 sets of run 6 minutes and walk 2 minutes
Week 6: Run 15 minutes continuously; 3 sets of run 8 minutes and walk 3 minutes; Run 18 minutes continuously
Week 7: 5 sets of run 6 minutes and walk 2 minutes; Run 22 minutes continuously; 3 sets of run 10 minutes and walk 2 minutes
Week 8: Run 26 minutes continuously; Run 16 minutes and walk 2 minutes, run 16 minutes; Run 30 minutes continuously
The running program is designed to begin gently and gradually increases in intensity as the session’s progress and as the participants improve. The end goal of the running program is for the participants to run continuously for thirty minutes, which equates to approximately five kilometres. A fridge magnet with the running program on it will also be sent out to participants, so that they can tick off sessions once they have completed them. At the end of the intervention, participants will take a photo of their completed fridge magnet and send it back to researchers through email.

As well as the running program, the intervention group will have access to a variety of different motivational posts through the private Facebook group to keep them engaged. Previous research has identified that the most engaging type of Facebook post is an opinion poll, followed by posts requesting participants to share helpful tips related to their intervention, for example healthy eating tips (Hales et al. 2014, p. 355). Posts that include links to related materials and posts that contain humorous content have also been shown to increase engagement and interactivity (Luarn et al. 2015, p. 508). In this study, a different type of motivational post will be posted to the intervention group each day over the eight week intervention period. The post type and its content will be varied from day to day to increase participants engagement and motivate them to continue participating in the program. These posts will also encourage social support and interaction amongst the participants, which will further increase their engagement with the program. An electronic log of Facebook posts and interaction will be kept to monitor engagement with the intervention
Intervention code [1] 296073 0
Behaviour
Intervention code [2] 296074 0
Lifestyle
Comparator / control treatment
had access to a hard-copy form of the running program only (in the form of a fridge magnet)
Control group
Active

Outcomes
Primary outcome [1] 299930 0
Cardio-respiratory fitness will be measured via the YMCA step test (Santo & Golding 2003, p. 111), which asks participants to step on a 30cm step for 3 minutes continuously, and then record their heart rate at the end. Participants are able to follow along with a Youtube clip that was purposefully created for this particular running program to ensure accurate performance of the test and to make this assessment as rigorous as possible.
Timepoint [1] 299930 0
Baseline, twelve weeks (coinciding with the last week of the running program) and twenty weeks
Primary outcome [2] 299931 0
Moderate to Vigorous Physical Activity
Physical activity will be measured via the Active Australia physical activity survey (Hacker et al. 2003). This survey is comprised of nine questions that measure the amount of time spent in moderate to vigorous physical activity within the past seven days
Timepoint [2] 299931 0
Baseline, twelve weeks (coinciding with the last week of the running program) and twenty weeks
Secondary outcome [1] 328576 0
Physical activity attitudes
Physical activity attitudes will be measured via The Exercise Attitude Questionnaire (EAQ-18)( Manigandan et al. 2004, p. 231), which is comprised of 18 statements where participants rate their attitude towards the statement on a 1-5 Likert scale from strongly disagree to strongly agree
Timepoint [1] 328576 0
Baseline, twelve weeks (coinciding with the last week of the running program) and twenty weeks
Secondary outcome [2] 328577 0
Self-efficacy
The Barriers Self Efficacy survey will be used to measure the participant’s self-efficacy or their belief in their own ability to succeed in specific situations (McAuley 1992, p. 66). This survey consists of 13 statements, where participants must rank how confident they are to continue exercising when particular issues arise for example, if there is bad weather (McAuley 1992, p. 70)
Timepoint [2] 328577 0
Baseline, twelve weeks (coinciding with the last week of the running program) and twenty weeks
Secondary outcome [3] 328578 0
Social support
The Social Support and Exercise survey will be used to evaluate the amount of support participants receive from their family and friends in regards to their physical activity (Sallis et al. 1987, p. 825), this survey is comprised of twelve questions where participants rank their social experiences on a likert scale from one to five (none to very often) (Sallis et al. 1987, p. 830)
Timepoint [3] 328578 0
Baseline, twelve weeks (coinciding with the last week of the running program) and twenty weeks.
Secondary outcome [4] 328755 0
Engagement with the Facebook group will be assessed by keeping a log of Facebook posts and interactions
Timepoint [4] 328755 0
twelve weeks (coinciding with the last week of the running program)

Eligibility
Key inclusion criteria
To be eligible to participate in this study, individuals must be:
*aged between 18 and 50
*currently living in Australia
*a current Facebook user
*able to read and understand English
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals will be excluded from this study if they:
*currently participate in a regular running program
*have a medical condition that would prevent them from participating in a regular running program
*are pregnant or planning to become pregnant within the next five months

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 concealed (central randomisation by computer)
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
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
The target sample size is 114 participants, this sample was generated via a power calculation with 80% power and an alpha of 0.05.

Analyse will be conducted on an intention to treat basis so that all participants enrolled in the study are retained in the analyses regardless of compliance with the intervention or assessments (Akobeng 2005, p. 842). Changes in the primary and secondary outcomes between the intervention and control groups will be analysed using random effects mixed modelling.

Compliance with the UniSA Run Free program will be analysed descriptively in terms of percentage of intended exercise sessions actually completed. Engagement with the intervention Facebook group will be analysed using data from Facebook insights, in terms of the number of unique visitors to the intervention Facebook group per day and per week across the eight week intervention period. Finally, the number of posts to the intervention Facebook group per participant will be analysed descriptively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/01/2016
Date of last participant enrolment
Anticipated
Actual
8/02/2016
Date of last data collection
Anticipated
Actual
8/08/2016
Sample size
Target
114
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294745 0
Self funded/Unfunded
Name [1] 294745 0
Dr Jocelyn Kernot
Country [1] 294745 0
Australia
Primary sponsor type
Individual
Name
Dr Jocelyn Kernot
Address
School of Health Sciences
University of South Australia
GPO Box 2471, Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 293596 0
Individual
Name [1] 293596 0
Dr Carol Maher
Address [1] 293596 0
School of Health Sciences
University of South Australia
GPO Box 2471, Adelaide, South Australia 5001
Country [1] 293596 0
Australia
Secondary sponsor category [2] 293597 0
Individual
Name [2] 293597 0
Dr Kobie Boshoff
Address [2] 293597 0
School of Health Sciences
University of South Australia
GPO Box 2471, Adelaide South Australia 5001
Country [2] 293597 0
Australia
Secondary sponsor category [3] 293598 0
Individual
Name [3] 293598 0
Ms Jemma Looyestyn
Address [3] 293598 0
School of Health Sciences
University of South Australia
GPO Box 2471, Adelaide, South Australia 5001
Country [3] 293598 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296162 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 296162 0
Ethics committee country [1] 296162 0
Australia
Date submitted for ethics approval [1] 296162 0
15/10/2014
Approval date [1] 296162 0
10/11/2014
Ethics approval number [1] 296162 0
0000033766

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

Contacts
Principal investigator
Name 69486 0
Dr Jocelyn Kernot
Address 69486 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 69486 0
Australia
Phone 69486 0
+61 83022575
Fax 69486 0
Email 69486 0
[email protected]
Contact person for public queries
Name 69487 0
Jocelyn Kernot
Address 69487 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 69487 0
Australia
Phone 69487 0
+61 83022575
Fax 69487 0
Email 69487 0
[email protected]
Contact person for scientific queries
Name 69488 0
Jocelyn Kernot
Address 69488 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 69488 0
Australia
Phone 69488 0
+61 83022575
Fax 69488 0
Email 69488 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA Web-Based, Social Networking Beginners' Running Intervention for Adults Aged 18 to 50 Years Delivered via a Facebook Group: Randomized Controlled Trial.2018https://dx.doi.org/10.2196/jmir.7862
N.B. These documents automatically identified may not have been verified by the study sponsor.