Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001087741
Ethics application status
Approved
Date submitted
5/07/2022
Date registered
5/08/2022
Date last updated
23/03/2023
Date data sharing statement initially provided
5/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of the Health4Life app
Scientific title
Assessing the usability and acceptability of a multiple health behavior change, self-monitoring mobile app for adolescents: A pilot trial of the Health4Life app
Secondary ID [1] 307273 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poor diet 326530 0
insufficient physical activity 326708 0
alcohol use 326709 0
tobacco use 326710 0
poor sleep 326711 0
excessive recreational screen time 326712 0
Condition category
Condition code
Public Health 323794 323794 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Health4Life app:
Health4Life app, is a multiple health behaviour change, self-monitoring mobile app for adolescents. Participants are asked to download the app and use it for 30 days, however actual app usage is completely at the participant's discretion. The Health4Life app consists of the following sections:
- Dashboard: provides a simple and visual portrayal of the user’s Big 6 health behaviours for the current day and a menu to access all other pages
- Diary: allows users to record their health behaviours and mood.
- Progress: allows users to view their progress for each of the 6 health behaviours.
- Goals: allows users to complete a guided goal-setting activity to set specific, measurable, achievable, relevant, time-bound (SMART) goals for any of the Big 6 behaviours.
- Rewards: allows users to view how many medals they have received and access information about what they need to do to earn medals for each health behaviour.
- Menu: users can access their profile and app settings along with resources and emergency contact details for relevant chat and telephone help lines.
- 7 Modules which provide users with detail information, tips and strategies and use cognitive behaviour therapy and motivational enhancement strategies to help users overcome potential barriers to changing their health behaviours (e.g. poor mood)
Information regarding the development of the Health4Life app is available in Thornton et al (2021) (https://pubmed.ncbi.nlm.nih.gov/33843590/).
Use of the Health4Life app will be monitored via app usage records which will record the date of time of app access, date and time participants access different sections of the app and any information participants enter into the app (i.e. self-reports of health behaviours and mood).

Peer-to-peer text messages:
Peer-like messages, co-created by young people, will be written as if they are from the users’ ‘Health4Life buddy’, a teenage character/avatar they will have previously ‘met’ within Health4Life app and selected to guide them through their interactions with the app. Messages are designed to prompt participants to access the Health4Life app and will be of 1-2 sentences in length. Delivery of these messages will be recorded.

Delivery of the text messages will be determined via micro-randomisation. Specifically all participants will be randomised to receive the intervention (peer-to-peer messages) or one of the comparators (generic messages or no message) once in the morning and once in the afternoon, every day for 30 days. At each randomisation point participants will have a 25% chance of receiving a peer-to-peer message, a 25% of receiving a generic message and a 50% chance of receiving no message (i.e. participants will receive between 0 and 2 messages each day, with an average of 1 message per day).
Intervention code [1] 323711 0
Behaviour
Intervention code [2] 323826 0
Lifestyle
Comparator / control treatment
All participants will receive access to the Health4Life app. The comparators for the peer-to-peer message intervention will be:
1) receiving no message, and
2) receiving a Generic text message: Generic messages co-created by young people will encourage adolescents to access the Heath4Life app (i.e. will not reference the Health4Life buddy characters, written as if from the app/ the ‘Health4Life app team’). Messages will be of 1-2 sentences in length.

Delivery of the text messages will be determined via micro-randomisation. Specifically all participants will be randomised to receive the intervention (peer-to-peer messages) or one of the comparators (generic messages or no message) once in the morning and once in the afternoon, every day for 30 days. At each randomisation point participants will have a 25% chance of receiving a peer-to-peer message, a 25% of receiving a generic message and a 50% chance of receiving no message (i.e. participants will receive between 0 and 2 messages each day, with an average of 1 message per day).

As a micro-randomised trial design will be employed each text message engagement strategy will be repeatedly randomised for each person. Therefore effect estimations will take advantage of within-subject comparisons between times when each person is randomized to an intervention option and times when the same person is randomized to a different intervention option.
Control group
Active

Outcomes
Primary outcome [1] 331564 0
Acceptability of text message timing, content and frequency. Assessed via bespoke 5-point Likert scale questions designed specifically for this study regarding perceptions of each specific section of the Health4Life app, timing, frequency and content of engagement text messages
Timepoint [1] 331564 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Primary outcome [2] 331565 0
Feasibility of micro-randomised trial (MRT) design. Assessed via bespoke 5-point likert scale questions regarding perceptions of the timing and frequency of engagement text messages and via a process evaluation of the custom SMS delivery system to be used to deliver text messages in this pilot ('Nudge' developed by Dr Thornton and Netfront Ltd) e.g. examination of error reports and any other issues that may arise during the pilot.
Timepoint [2] 331565 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [1] 410312 0
Overall usability of the Health4Life app assessed via the System Usability Scale (SUS), a 10-item scale using a 5-point Likert scale.

(Brooke, J. (1996). SUS: A “quick and dirty” usability scale. In P. Jordan, B. Thomas, & B. Weerdmeester (Eds.), Usability evaluation in industry (pp. 189–194). London, UK: Taylor & Francis. )
Timepoint [1] 410312 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [2] 410313 0
Safety of using the Health4Life app assessed via changes in participants' sleep behaviours between baseline and follow-up.

Sleep: Assessed via the Pediatric Daytime Sleepiness Scale and Modified Sleep Habits Survey.
Timepoint [2] 410313 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [3] 411788 0
Acceptability of the Health4Life app: Assessed via bespoke 5-point Likert scale questions designed specifically for this study regarding perceptions of each specific section of the Health4Life app.
Timepoint [3] 411788 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [4] 412254 0
Safety of using the Health4Life app assessed via changes in participants' screen and sitting time between baseline and follow-up.

Screen and sitting time: Assessed via International Sedentary Assessment Tool and Active and passive screen behaviours (bespoke questionnaire developed as a part of the Health4Life trial (ACTRN12619000431123))
Timepoint [4] 412254 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [5] 412255 0
Safety of using the Health4Life app assessed via changes in participants' diet between baseline and follow-up.

Diet: Assessed via the SPANS Nutrition Questions regarding sugar sweetened beverages, energy drinks, fruits and vegetables.
Timepoint [5] 412255 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [6] 412256 0
Safety of using the Health4Life app assessed via changes in participants' physical activity between baseline and follow-up

Physical activity: Assessed via the Active Healthy Kids Australia Survey, AIHW Active Australia Survey and bespoke yes/no questions regarding participation in organised sport and use of Active transport.
Timepoint [6] 412256 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [7] 412257 0
Safety of using the Health4Life app assessed via changes in participants' alcohol use between baseline and follow-up.

Alcohol: Assessed via the Alcohol Use Questionnaire - bespoke questionnaire developed as a part of the Health4Life trial (ACTRN12619000431123) that assesses lifetime and last 6 months frequency of use of alcohol and quantity of alcohol consumption on a typical day with catagorical response options (e.g. yes/no, none/1-2 drinks/3-4 drinks/5-6 drinks/7-9 drinks/ 10+ drinks) .
Timepoint [7] 412257 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [8] 412258 0
Safety of using the Health4Life app assessed via changes in participants' smoking between baseline and follow-up

Smoking: Assessed via the Cigarette Use Questionnaire - bespoke questionnaire developed as a part of the Health4Life trial (ACTRN12619000431123) that assesses lifetime and last 6 months frequency of tobacco use and quantity of tobacco use on a typical day with catagorical response options.
Timepoint [8] 412258 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [9] 412259 0
Safety of using the Health4Life app assessed via changes in participants' ecigarette use between baseline and follow-up.

eCigarette use: Assessed via the eCigarette Use Questionnaire - bespoke questionnaire developed as a part of the Health4Life trial (ACTRN12619000431123) that assesses lifetime and last 6 months frequency and quantity of eCigarette use with catagorical response options.
Timepoint [9] 412259 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [10] 412261 0
Safety of using the Health4Life app assessed via changes in participants' psychological distress between baseline and follow-up.

Psychological distress: Assessed via the Kessler 6 Distress Scale (K-6).
Timepoint [10] 412261 0
Online Follow-up assessment to occur 30 days after completion of the baseline assessment.
Secondary outcome [11] 412262 0
Safety of using the Health4Life app assessed via number of moderate to severe adverse events reported via emails or phone calls to the research team.

Timepoint [11] 412262 0
Ongoing throughout the duration of the study.

Eligibility
Key inclusion criteria
1. Aged 13-17 years
2. Living in Australia
3. Access to a smartphone
4. Willing to download the Health4Life app
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Aged below 13 years or above 18 years
2. Not living in Australia
3. No access to a smartphone
4. Not willing or unable to download the Health4Life app
5. Insufficient English literacy

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 is concealed and automatically generated by computer.

As a micro-randomised trial design will be employed, participants will be randomly allocated to receive either peer-to-peer messages, generic messages or no message twice a day for the 30 days of the trial. This allocation will be automatically generated by the custom SMS delivery system developed for this project.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A micro-randomised trial design will be employed - analogous to multiple within person comparisons.

The provision of the different types of messages will be determined via micro-randomisation so that each participant is randomised multiple times a day to receive a different message type. Every morning (approx 7:30am) and every afternoon (approx 8pm) every participant will be ranomised to receive either:
1. A peer-to-peer text message
2. A generic text message
3. No text message.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Quantitative data will be analysed using IBM SPSS Statistics (IBM Corporation). Descriptive statistics will be generated exploring the primary outcome measures listed above. For open-ended responses collected, using an inductive approach, one researcher will code the responses and group them according to key themes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2022
Actual
15/11/2022
Date of last participant enrolment
Anticipated
28/04/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
75
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311570 0
University
Name [1] 311570 0
The University of Sydney
Country [1] 311570 0
Australia
Primary sponsor type
University
Name
NHMRC CTC
Address
92 Parramatta Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 313242 0
University
Name [1] 313242 0
The Matilda Centre for Research in Mental Health and Substance Use
Address [1] 313242 0
University of Sydney
Matilda Centre
Level 6, Jane Foss Russell Building, G02,
Camperdown NSW 2006.
Country [1] 313242 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311018 0
The University of Sydney Ethics Committee
Ethics committee address [1] 311018 0
Ethics committee country [1] 311018 0
Australia
Date submitted for ethics approval [1] 311018 0
26/05/2022
Approval date [1] 311018 0
27/09/2022
Ethics approval number [1] 311018 0
2022/480

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

Contacts
Principal investigator
Name 119714 0
Dr Louise Thornton
Address 119714 0
The Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell Building, G02
Camperdown NSW 2006
Country 119714 0
Australia
Phone 119714 0
+61 403 744 089
Fax 119714 0
Email 119714 0
louise.thornton@sydney.edu.au
Contact person for public queries
Name 119715 0
Louise Thornton
Address 119715 0
The Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell Building, G02
Camperdown NSW 2006
Country 119715 0
Australia
Phone 119715 0
+61 403 744 089
Fax 119715 0
Email 119715 0
louise.thornton@sydney.edu.au
Contact person for scientific queries
Name 119716 0
Louise Thornton
Address 119716 0
The Matilda Centre for Research in Mental Health and Substance Use
Level 6, Jane Foss Russell Building, G02
Camperdown NSW 2006
Country 119716 0
Australia
Phone 119716 0
+61 403 744 089
Fax 119716 0
Email 119716 0
louise.thornton@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identified individual patient level data.
When will data be available (start and end dates)?
From after trial close-out until at least 20 years post-study closure (unless extended)
Available to whom?
Researchers working in partnership with the principle investigator (Dr Louise Thornton)
Available for what types of analyses?
Available for meta analyses and other related research questions
How or where can data be obtained?
By emailing the principal investigator, Dr Louise Thornton
Email: louise.thornton@sydney.edu.au
Telephone: +61 2 8627 9002


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16282Study protocol  louise.thornton@sydney.edu.au By emailing Dr Thornton, until a planned peer-revi... [More Details] 384164-(Uploaded-04-08-2022-08-52-57)-Study-related document.docx
16283Statistical analysis plan  louise.thornton@sydney.edu.au By emailing Dr Thornton, until a planned peer-revi... [More Details]
16284Informed consent form  louise.thornton@sydney.edu.au By emailing Dr Thornton until published. 384164-(Uploaded-27-07-2022-11-36-14)-Study-related document.pdf
16748Informed consent form  louise.thornton@sydney.edu.au By emailing Dr Thornton until published. 384164-(Uploaded-27-07-2022-11-36-01)-Study-related document.pdf



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.