Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000899448
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
7/07/2016
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of using Fitbits to promote physical activity in inactive Victorian adolescents
Scientific title
Efficacy of using Fitbits to promote physical activity in inactive Victorian adolescents: Technological revolution or fad?
Secondary ID [1] 289238 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RAW-PA: Raising Awareness of Physical Activity Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 298811 0
Sedentary behaviour 299415 0
Condition category
Condition code
Public Health 298861 298861 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this intervention is to evaluate the effectiveness of the Fitbit Flex (and accompanying app) combined with digital behaviour change resources to promote physical activity in inactive adolescents. The intervention is grounded in Social Cognitive Theory and Behaviour Choice Theory. Following the completion of baseline measures, schools will be randomised to either the intervention or wait-list control group. The 12-week intervention will include a Fitbit Flex and accompanying app, weekly individual and/or team missions to complete, and digital behaviour change resources accessed via social media (e.g. infographics, social forums, short videos etc.). Alerts to new ‘missions’ and content will be delivered via email or text message 2-3 times per week. Participants will be asked to wear the monitor as much as possible throughout the 12 weeks. Adolescents will access the resources and be encouraged to participate in 12 missions (delivered at the start of each week) in their own time. Examples of weekly missions include ‘Break it up’, where adolescents will be asked to identify share ideas on how to move more and sit less, ‘Buddy up’, where participants will try to identify and implement ways to help others (e.g. family) to be more active, and ‘Build it up’, where participants will be asked to think about changing one thing that could help them to be more active. The accompanying resources match the weekly themes (e.g. how to set SMARTER goals), will step participants through the behaviour change process and target behaviour change techniques in an interactive, flexible way. The focus of the intervention is the accumulation of physical activity across the day.

Adherence to the intervention will be monitored by documenting engagement with the intervention elements (e.g. numbers reporting engagement with resources, social media contributions etc.).
Intervention code [1] 294777 0
Lifestyle
Intervention code [2] 294778 0
Behaviour
Comparator / control treatment
Wait-list control group for 6 months. The wait-list control group will be offered the intervention after the 6 month assessment.
Control group
Active

Outcomes
Primary outcome [1] 298378 0
Objectively-measured physical activity (students)

Students will wear accelerometers for 8 consecutive days at each time point.
Timepoint [1] 298378 0
Baseline, post-intervention, and 6-month follow-up
Primary outcome [2] 298863 0
Objectively-measured sedentary time (students)

Students will wear accelerometers for 8 consecutive days at each time point.
Timepoint [2] 298863 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [1] 323992 0
Number of steps taken per day (students)

Assessed using wrist-worn Fitbit monitors.
Timepoint [1] 323992 0
Assessed during 12-week intervention
Secondary outcome [2] 323993 0
Leisure time physical activity (students)

Assessed using validated questionnaires including brief moderate-to-vigorous self-report measure and M-SPAN student survey.
Timepoint [2] 323993 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [3] 323995 0
Anthropometric assessments (height, weight, waist circumference) - students

Height - assessed using portable stadiometer (cm)
Weight - assessed using calibrated electronic scales (kg)
Waist circumference - measured using flexible steel tape at the narrowest point around the waist (cm)
Timepoint [3] 323995 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [4] 323997 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Self-efficacy - measured using Social Cognitive Measures related to Adolescent Physical Activity Scale
Timepoint [4] 323997 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [5] 323998 0
Demographic survey (e.g. employment status, highest level of schooling, country of birth etc.) completed by parents/guardians
Timepoint [5] 323998 0
Baseline
Secondary outcome [6] 324003 0
Intervention acceptability and enjoyment (students)

Information concerning adolescents' enjoyment and acceptability of the intervention components will be assessed via purpose-designed questions (e.g. Which aspects of the program did you enjoy etc.).
Focus groups will also be conducted to examine adolescents' perspectives on the intervention program using purpose-designed questions.
Timepoint [6] 324003 0
Post-intervention
Secondary outcome [7] 324004 0
Feasibility - engagement with the intervention

Measured via engagement with social media and weekly missions
Timepoint [7] 324004 0
During 12-week intervention
Secondary outcome [8] 324005 0
Intervention feasibility and acceptability (teachers)

Interviews will be conducted with teachers to examine their thoughts on the intervention program using purpose-designed questions from an organisational perspective.
Timepoint [8] 324005 0
Post-intervention
Secondary outcome [9] 325465 0
Leisure time sedentary behaviour (students)

Assessed using validated questionnaires including M-SPAN student survey.
Timepoint [9] 325465 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [10] 325466 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Social support - measured using Social Cognitive Measures related to Adolescent Physical Activity Scale
Timepoint [10] 325466 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [11] 325467 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Behavioural strategies - measured using Social Cognitive Measures related to Adolescent Physical Activity Scale
Timepoint [11] 325467 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [12] 325468 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Barriers to physical activity - measured using Adolescent Physical Activity Perceived Barriers Scale
Timepoint [12] 325468 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [13] 325469 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Physical activity enjoyment - measured using Physical Activity Enjoyment Scale (PACES)
Timepoint [13] 325469 0
Baseline, post-intervention, and 6-month follow-up
Secondary outcome [14] 325470 0
Physical activity enablers and barriers - assessed via self-report questionnaires (students)

Neighbourhood safety - measured using Neighbourhood Environment Walkability Scale for Youth
Timepoint [14] 325470 0
Baseline, post-intervention, and 6-month follow-up

Eligibility
Key inclusion criteria
Adolescents are eligible to participate in this study if they:
- Are in Year 8
- Attend a secondary school located in a socioeconomically disadvantaged area
- Have access to the internet
- Do not meet current physical activity recommendations for youth
- Do not engage in regular organised physical activity outside of school
- Do not own and/or have not used a wearable activity tracker before
Minimum age
13 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adolescents will not be eligible to participate if they are:
- Aged 12 years at the time of first baseline assessments
- Have used and/or own a wearable activity tracker

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 will not be concealed. Schools are eligible to participate if they are located within a socioeconomically disadvantaged area of Melbourne. Voluntary, written informed organisational consent will be obtained for schools to participate. Participants (students and teachers) will then be recruited through schools. Year 8 students who meet the minimum age criteria will receive a recruitment pack containing Plain Language Statements and Consent Forms to take home to their parents, In order to participate, students will be required to return signed parental consent forms, which will also include student assent to participate, to their school for collection by the research team. Once baseline assessments have been completed, schools will be randomised into either the intervention or wait-list control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project will use a group randomised controlled trial design. Schools will be randomly allocated to intervention or wait-list control groups for the duration of the study.

Schools will be match-paired based on their size and then randomly allocated to either the intervention or control using a computer-based random number generator. Participants attending schools in the intervention group will receive the 12 week physical activity program. Participants attending schools in the wait-list control group will not receive the physical activity program during the study period. However, at the conclusion of the final assessments, participants will receive the information and resources.
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2016
Actual
8/08/2016
Date of last participant enrolment
Anticipated
Actual
13/06/2017
Date of last data collection
Anticipated
31/05/2018
Actual
22/06/2018
Sample size
Target
300
Accrual to date
Final
280
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293640 0
Other Collaborative groups
Name [1] 293640 0
Victorian Health Promotion Foundation (VicHealth)
Country [1] 293640 0
Australia
Primary sponsor type
Individual
Name
Dr Nicola Ridgers
Address
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country
Australia
Secondary sponsor category [1] 292474 0
None
Name [1] 292474 0
Address [1] 292474 0
Country [1] 292474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295085 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 295085 0
Ethics committee country [1] 295085 0
Australia
Date submitted for ethics approval [1] 295085 0
03/06/2016
Approval date [1] 295085 0
20/07/2016
Ethics approval number [1] 295085 0
2016-179

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

Contacts
Principal investigator
Name 65922 0
Dr Nicola Ridgers
Address 65922 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 65922 0
Australia
Phone 65922 0
+61 3 9244 6718
Fax 65922 0
Email 65922 0
[email protected]
Contact person for public queries
Name 65923 0
Samuel Lai
Address 65923 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 65923 0
Australia
Phone 65923 0
+61 3 9246 8350
Fax 65923 0
Email 65923 0
[email protected]
Contact person for scientific queries
Name 65924 0
Nicola Ridgers
Address 65924 0
Institute for Physical Activity and Nutrition (IPAN),
Deakin University,
221 Burwood Highway,
Burwood,
VIC 3125.
Country 65924 0
Australia
Phone 65924 0
+61 3 9244 6718
Fax 65924 0
Email 65924 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
EmbaseUsing the Technology Acceptance Model to Explore Adolescents' Perspectives on Combining Technologies for Physical Activity Promotion Within an Intervention: Usability Study.2020https://dx.doi.org/10.2196/15552
EmbaseEffect of commercial wearables and digital behaviour change resources on the physical activity of adolescents attending schools in socio-economically disadvantaged areas: the RAW-PA cluster-randomised controlled trial.2021https://dx.doi.org/10.1186/s12966-021-01110-1
N.B. These documents automatically identified may not have been verified by the study sponsor.