Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000846729
Ethics application status
Approved
Date submitted
21/05/2022
Date registered
16/06/2022
Date last updated
16/06/2022
Date data sharing statement initially provided
16/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled m-health trial evaluating the effect of gamification on physical activity, sleep quantity, and quality of life in young adults
Scientific title
A randomised controlled m-health trial evaluating the effect of gamification on physical activity, sleep quantity, and quality of life in young adults
Secondary ID [1] 307184 0
None
Universal Trial Number (UTN)
Trial acronym
LevantApp
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 326409 0
Condition category
Condition code
Public Health 323695 323695 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The LevantApp Study employed a 2-arm parallel group (1:1) single blind randomized controlled trial, with targeted physical activity and sleep quality as primary outcomes' in an 8-week intervention using an m-health approach. All individuals were provided a wearable device and engagement prompts to participate in the `LevantApp Challenge´ which consisted of determining who improved their levels of physical activity and sleep the most. However, the intervention group was given immediate feedback (daily reports) to the group success (such as points, leaderboards, and progress bars) while the control group had no information of the performance of the other participants.
Participants were advised to wear the wristband (Muvone, Secmotic, Spain) on the nondominant wrist in accordance with manufacturer guidelines. Except for water-based activities, the device must be worn during all waking hours, including during sleep. To avoid bias during this phase, only a brief description of the `LevantApp Challenge´ was given during this visit.

If you are here, it is because you are going to participate in the #LevantApp challenge. What does this experience consist of?

Your active habits (e.g., how much we move) and sedentary habits (e.g., for how long we sit) will be assessed and we will propose challenges to change your lifestyle. An important prize awaits you at the end of this competition. We do not anticipate you more… in the following link you will be able to access LevantApp. Shall we start?

Every evening (once per day) all users received a notification via Whatsapp with an individual link to reflect on their physical activities and sleep duration for that day. Goals to be entered into the link for physical activity included; the daily step count, the daily number of minutes of moderate to vigorous intensity and the energy expenditure; and for sleep, the sleep hours (time to wake (hh:mm) minus time to bed (hh:mm). Percentage of time wearable device worn will be determined by accessing app analytics. Participants allocated to the experimental group received feedback on their daily progress on bar charts which displays their progress toward their goals (personalised to participants once per day). Daily progress in relation to the goals: physical activity, step count, energy expenditure and sleep quantity was showed.
Intervention code [1] 323636 0
Lifestyle
Intervention code [2] 323719 0
Treatment: Devices
Comparator / control treatment
Only participants allocated to the experimental group received feedback on their daily progress on bar charts which displays their progress toward their goals. Participants in the control group will receive information regarding their own progress daily in relation to the goals: physical activity, step count, energy expenditure and sleep quantity was showed.
Control group
Active

Outcomes
Primary outcome [1] 331442 0
A wrist-worn triaxial accelerometer (Mi Smart Band 6, Xiaomi, Beijing, China) was used to assess participants’ daily number of steps as a primary outcome.
Timepoint [1] 331442 0
Baseline, 8 weeks post-intervention commencement.
Secondary outcome [1] 409900 0
Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), which has shown good reliability and sensitivity to change in intervention studies (Buysse, Reynolds, Monk, Berman, & Kupfer, 1989).
Timepoint [1] 409900 0
Baseline, 8 weeks post-intervention commencement.
Secondary outcome [2] 409901 0
Sedentary behaviour
The Sedentary Behaviour Questionnaire (SBQ) (Munguía-Izquierdo et al., 2013) was created to measure how much time people spend doing nine different activities (watching TV, playing computer/video games, sitting while listening to music, sitting while talking on the phone, doing paperwork or office work, sitting and reading, playing a musical instrument, doing arts and crafts, and sitting while driving/riding in a car, bus, or train). For weekdays and weekends, the 9 things were completed separately. "On a normal workday, how much time do you spend (from when you wake up until you go to bed) doing the following?" was the question for weekday reporting.
Timepoint [2] 409901 0
Baseline, 8 weeks post-intervention commencement.
Secondary outcome [3] 409902 0
Quality of life
The SF-36 is a self-report health status questionnaire including eight subscales: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain and general health. Scores range from 0 to 100 with lower scores indicating more disability and higher scores indicating less disability
Timepoint [3] 409902 0
Baseline, 8 weeks post-intervention commencement
Secondary outcome [4] 410352 0
The Spanish long version of the ‘International Physical Activity Questionnaire’ (IPAQ) was used to subjectively measure total physical activity and moderate-to-vigorous-intensity physical activity (MVPA)
Timepoint [4] 410352 0
Baseline, 8 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
To take part in the study, participants have to live in Seville (Spain), be 18–55 years of age and have access to an iOS or Android smartphone or tablet with internet access. Participants were recruited across the campus of the University of Seville, through social media and word of mouth.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they had a diagnosis of a sleep disorder such as insomnia, obstructive sleep apnoea or narcolepsy, if they were taking any sleep-aid medication or having any condition which would contraindicate participation in physical activity.

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)
allocation was concealed using a central computer system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation list.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
6/05/2022
Date of last participant enrolment
Anticipated
15/07/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
100
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 24781 0
Spain
State/province [1] 24781 0
Seville

Funding & Sponsors
Funding source category [1] 311490 0
University
Name [1] 311490 0
University of Seville
Country [1] 311490 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Facultad de Ciencias de la Educación. Dpto. Educación Física y Deporte. Pirotecnia s/n. Seville (Spain). E-41013
Country
Spain
Secondary sponsor category [1] 312892 0
None
Name [1] 312892 0
Address [1] 312892 0
Country [1] 312892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310951 0
University of Seville
Ethics committee address [1] 310951 0
Ethics committee country [1] 310951 0
Spain
Date submitted for ethics approval [1] 310951 0
01/04/2022
Approval date [1] 310951 0
04/04/2022
Ethics approval number [1] 310951 0

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

Contacts
Principal investigator
Name 119470 0
Prof Borja Sañudo
Address 119470 0
Facultad de Ciencias de la Educación. C/ Pirotecnia s/n. Seville (Spain). E-41013
Country 119470 0
Spain
Phone 119470 0
+34652387090
Fax 119470 0
Email 119470 0
[email protected]
Contact person for public queries
Name 119471 0
Borja Sañudo
Address 119471 0
Facultad de Ciencias de la Educación. C/ Pirotecnia s/n. Seville (Spain). E-41013
Country 119471 0
Spain
Phone 119471 0
+34652387090
Fax 119471 0
Email 119471 0
[email protected]
Contact person for scientific queries
Name 119472 0
Borja Sañudo
Address 119472 0
Facultad de Ciencias de la Educación. C/ Pirotecnia s/n. Seville (Spain). E-41013
Country 119472 0
Spain
Phone 119472 0
+34652387090
Fax 119472 0
Email 119472 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 underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected]).


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.