Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000399695
Ethics application status
Approved
Date submitted
29/03/2023
Date registered
19/04/2023
Date last updated
28/05/2024
Date data sharing statement initially provided
19/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Triple E Project: Assessing Strategies for Enhancing Engagement with eHealth Approaches Targeting Lifestyle Behaviours in Adolescents
Scientific title
The Triple E Project: Assessing Strategies for Enhancing Engagement with eHealth Approaches Targeting Lifestyle Behaviours in Adolescents
Secondary ID [1] 309149 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poor diet 329256 0
Low levels of physical activity 329257 0
Poor sleep 329258 0
Excessive recreational screen time 329259 0
Alcohol use 329262 0
Tobacco use 329263 0
Condition category
Condition code
Cardiovascular 326211 326211 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be provided with access to the Health4Life app for 3 months. The Health4Life app is a multiple health behaviour change, self-monitoring mobile app for adolescents. See more information about the Health4Life app under the 'control treatment' section.

Participants will also receive access to a combination of the following four adherence strategies over the same 3-month period when they have access to the Health4Life app.

Gamification in the Health4Life app:
Gamification is the use of game design elements in non-game contexts. In the Health4Life app, users assigned to the gamification intervention condition can view how many medals they have earnt for meeting health behaviour guidelines. Those randomised to receive the gamification component will receive additional access to a ‘Medal Tally Leader board’. On first use, users will be assigned to a team. The combined medal tallies of team members will be displayed in a leader board, similar to an Olympic medal tally, to be updated daily. Teammates will be able to communicate with other teammates by sending ‘high fives’ or ‘thumbs up’ messages of support.

Access to a health coach:
Participants in the health coach condition will be asked to attend an initial phone call with the health coach for approximately 15 minutes within one week following completion of the study baseline assessment (i.e., within one week into the 3-month study period). On this initial call the health coach will explain how the health coach intervention works and answer any questions participants may have about the intervention or the research study. During this call the health coach will also conduct an initial brief assessment of the participants’ health behaviour goals and their engagement with the Health4Life app, provide support to any participants experiencing difficulties with their health behaviour goals or the Health4Life app, and also set expectations for any future ‘check-ins’ with participants. Participants will then be sent a message once a fortnight via their preferred method of communication (SMS or email) informing them about the availability of a health coach to ask questions of or request additional information or support. If a participant indicates interest in receiving text messages, email, or telephone support from the health coach, the health coach will respond using the method indicated. These ‘check-ins’ will include personalised messages regarding engagement with the Health4Life app, checking-in on how participants feel they are going with their health behaviours, answering any questions they have, and encouraging engagement with the app. These interactions will be guided by a semi-structured health coach manual that has been specifically designed for this study and draws on the guiding principles of Mohr et al.’s (2011; doi: 10.2196/jmir.1602) Supportive Accountability Model. It will be up to the adolescent to decide and manage their level of engagement with the health coach. The 'check-ins' will be offered for three months. The health coaches will be allied health professionals, such as psychologists, or Research Assistants with adequate training and experience in supportive counselling, mental health first aid and responding to child safety and wellbeing risks.

Parent factsheets
Nominated parents/guardians of participants will be provided with parent resources regarding the Big 6 health behaviours (healthy eating, physical activity, sleep, recreational screen time, alcohol consumption, tobacco consumption) and how to help their adolescent improve their health behaviours, plus tips and conversation starters regarding the Health4Life app. These resources have been designed specifically for this study. Parents will be provided with access to a website from where they can download 6 evidence based-fact sheets and emailed one of these fact sheets per-fortnight over the 3 month study period.

Text message prompts
Participants randomised to this condition will receive a text message every three days to prompt them to use the Health4Life app. To ensure messages are acceptable and likely to engage adolescents, messages have been co-created by adolescents. With assistance from a senior researcher, two Young Person Research Assistants (aged 17 and 20) employed for 6 months developed and conducted an online consultation via Zoom with twenty five Adolescent Expert Advisors. They then used the advisors’ feedback to generate text messages designed to engage adolescents with the Health4Life app.

Participants will be allocated to one of the following conditions:
1. Health4Life app + Gamification + Health Coach + Parent Resources + Text Messages
2. Health4Life app + Gamification + Health Coach + Parent Resources
3. Health4Life app + Gamification + Health Coach + Text Messages
4. Health4Life app + Gamification + Health Coach
5. Health4Life app + Gamification + Parent Resources + Text Messages
6. Health4Life app + Gamification + Parent Resources
7. Health4Life app + Gamification + Text Messages
8. Health4Life app + Gamification
9. Health4Life app + Health Coach + Parent Resources + Text Messages
10. Health4Life app + Health Coach + Parent Resources
11. Health4Life app + Health Coach + Text Messages
12. Health4Life app + Health Coach
13. Health4Life app + Parent Resources + Text Messages
14. Health4Life app + Parent Resources
15. Health4Life app + Text Messages
16. Health4Life app

Adolescent participants’ engagement with the Health4Life app and gamification adherence strategy will be assessed using app analytics data (e.g., app logins, clicks, logging information in the app). Participants’ engagement with the health coach adherence strategy will be assessed by the number of fortnightly health coach ‘check-ins’ each participant opts into.

Adolescent participants’ perceptions of each of the adherence strategies they are allocated to will be assessed at the 3-month post-commencement of intervention follow-up assessment. Specifically, participants will be asked to report, on 5-point Likert scales, the degree to which each of the adherence strategies (gamification, health coach, parent resources, text messages) helped them to engage with the Health4Life app and improve their health behaviours. Participants will also be given the opportunity to provide open-ended feedback on what it was about each strategy that they found helpful or unhelpful, as well as suggestions for how each strategy might be improved.

Parent/guardian engagement with the parent resources adherence strategy will be assessed using email marketing analytics data (e.g., email opens, link clicks, attachment downloads) and website analytics (e.g., clicks, document downloads). Parents/guardians allocated to the parent resources condition will also be asked during the 3-month post-commencement of intervention follow-up assessment to report how many parent resources they read during the study.
Intervention code [1] 325597 0
Prevention
Intervention code [2] 325598 0
Lifestyle
Comparator / control treatment
All participants will be provided with access to the Health4Life app for 3 months. The Health4Life app is a multiple health behaviour change, self-monitoring mobile app for adolescents. Those in the control condition will be provided access to the Health4Life app and no additional interventions for the 3 month study period.

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:
- detailed information about the Australian health guidelines for the big 6 cardiovascular disease health behaviours (physical activity, healthy eating, sleep, screen time, smoking, alcohol);
- motivational interviewing (decisional balance) exercises designed to increase participants’ motivation to improve health behaviours;
- goal setting exercises designed to help participants set SMART (specific, measurable, achievable, relevant, time-bound) goals for improving their health behaviours;
- problem solving exercises to help participants overcome barriers to health behaviour change;
- cognitive behaviour therapy exercises designed to help participants understand and challenge types of thinking that can influence health behaviours;
- 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).
All modules are estimated to take 20 minutes to complete and will be immediately available upon downloading the app. Participants can work through these at their own pace.

Adolescent participants’ engagement with the Health4Life app will be assessed using app analytics data (e.g., app logins, clicks, logging information in the app).

Information regarding the development of the Health4Life app is available in Thornton et al (2021; doi: 10.2196/25513) and the app is available via the leading app stores:

Google Play: https://play.google.com/store/apps/details?id=com.netfront.health4life&hl=en_AU&gl=US

iTunes: https://apps.apple.com/au/app/health4lifeapp/id1468424907)
Control group
Active

Outcomes
Primary outcome [1] 334092 0
Engagement with the Health4Life app, as measured by an Engagement Index modelled on Taki et al.’s (2017; doi:10.2196/mhealth.7236) App engagement index.

The Engagement Index will include 5 subindices.

Sub index 1: click depth (number of pages of the app visited)
Timepoint [1] 334092 0
Data for this sub index will be collected continuously via the Health4Life app over the three month intervention period.
Primary outcome [2] 334389 0
Engagement with the Health4Life app, as measured by an Engagement Index modelled on Taki et al.’s (2017; doi:10.2196/mhealth.7236) App engagement index.

The Engagement Index will include 5 subindices.

Sub index 2: loyalty (how frequently a user accessed the app)
Timepoint [2] 334389 0
Data for this sub index will be collected continuously via the Health4Life app over the three month intervention period.
Primary outcome [3] 334390 0
Engagement with the Health4Life app, as measured by an Engagement Index modelled on Taki et al.’s (2017; doi:10.2196/mhealth.7236) App engagement index.

The Engagement Index will include 5 subindices.

Sub index 3: volume of contributions (number of times users self-report a health behaviour or set a goal within the app).
Timepoint [3] 334390 0
Data for this sub index will be collected continuously via the Health4Life app over the three month intervention period.
Secondary outcome [1] 419315 0
Usability of the Health4Life app between experimental conditions, as measured by the System Usability Scale (SUS; Brooke 2013).
Timepoint [1] 419315 0
3-month post-commencement of intervention follow-up assessment.
Secondary outcome [2] 419316 0
Acceptability of the Health4Life app between experimental conditions, as measured by the Mobile App Rating Scale-User Version (Stoyanov et al. 2016; doi:10.2196/mhealth.5849).
Timepoint [2] 419316 0
3-month post-commencement of intervention follow-up assessment.
Secondary outcome [3] 419319 0
Intention to use the Health4Life app in the future, as assessed by an item adapted from Vankatesh et al. (2003; doi: 10.2307/30036540).
Timepoint [3] 419319 0
3-month post-commencement of intervention follow-up assessment.
Secondary outcome [4] 419320 0
Quality of diet (NSW Schools Physical Activity and Nutrition Survey [SPANS] 2015, Hardy et al. 2016)
Timepoint [4] 419320 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [5] 419321 0
Levels of physical activity assessed with questions from The Active Australia Survey (Australian Institute of Health and Welfare 2003).
Timepoint [5] 419321 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [6] 419322 0
Quality of sleep assessed with questions from Drake et al. (2003, doi: 10.1093/sleep/26.4.455)
Timepoint [6] 419322 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [7] 419323 0
Level of recreational screen time assessed with questions from Prince et al. (2017, doi: 10.7717/peerj.4130)
Timepoint [7] 419323 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [8] 419324 0
Alcohol consumption (Teesson et al. 2020, doi: 10.1136/bmjopen-2019-035662)
Timepoint [8] 419324 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [9] 419325 0
Tobacco consumption (Youth risk behavior survey, Centers for Disease Control and Prevention 2019).
Timepoint [9] 419325 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [10] 419890 0
Body height (in centimeters) measured with tape measure
Timepoint [10] 419890 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [11] 419891 0
Body weight (in kilograms) measured with bathroom scales
Timepoint [11] 419891 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [12] 419892 0
Waist circumference (in centimeters) measured with tape measure
Timepoint [12] 419892 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [13] 420476 0
This is an additional primary outcome.

Engagement with the Health4Life app, as measured by an Engagement Index modelled on Taki et al.’s (2017; doi:10.2196/mhealth.7236) App engagement index.

The Engagement Index will include 5 subindices.

Sub index 4: recency (average time difference between each session a user accessed the app)
Timepoint [13] 420476 0
Data for this sub index will be collected continuously via the Health4Life app over the three month intervention period.
Secondary outcome [14] 420477 0
This is an additional primary outcome.

Engagement with the Health4Life app, as measured by an Engagement Index modelled on Taki et al.’s (2017; doi:10.2196/mhealth.7236) App engagement index.

The Engagement Index will include 5 subindices.

Sub index 5: subjective feedback on the app as assessed by the total score on the Mobile App Rating Scale – User Version (Stoyanov et al. 2016; doi:10.2196/mhealth.5849)
Timepoint [14] 420477 0
3-month post-commencement of intervention follow-up assessment.
Secondary outcome [15] 420478 0
User-rated quality of the Health4Life app between experimental conditions, as measured by the Mobile App Rating Scale-User Version (Stoyanov et al. 2016; doi:10.2196/mhealth.5849).
Timepoint [15] 420478 0
3-month post-commencement of intervention follow-up assessment.
Secondary outcome [16] 420479 0
Levels of physical activity assessed with questions from The 2016 Active Healthy Kids Australia Report Card on Physical Activity for Children and Young People (Active Healthy Kids Australia 2016).
Timepoint [16] 420479 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [17] 420480 0
Quality of sleep assessed with questions from Short et al. (2013, doi: 10.2147/NSS.S38369)
Timepoint [17] 420480 0
Baseline and 3-month post-commencement of intervention follow-up assessment.
Secondary outcome [18] 420481 0
Level of recreational screen time assessed with questions from Teesson et al. (2020, doi: 10.1136/bmjopen-2019-035662)
Timepoint [18] 420481 0
Baseline and 3-month post-commencement of intervention follow-up assessment.

Eligibility
Key inclusion criteria
(i) Adolescent aged 13-17 years of age (inclusive) with a parent/guardian willing to be a part of the study

(ii) Adolescent and parent/guardian reside in Australia

(ii) Adolescent has access to a smartphone with Apple or Android operating systems that can receive text messages and phone calls

(iii) Parent/guardian and adolescent have sufficient knowledge of English to read and interact with an app pitched at a reading level for 7th grade

(iv) Parent/guardian and adolescent provide informed e-consent
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Adolescent enrolled in an alternative randomised health risk behaviour management program

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to one of 16 experimental conditions through the randomise function in RedCap. A biostatistician with no role in participant recruitment will produce the stratified randomisation scheme to be used by RedCap to randomise participants
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Where studies investigating the effect of the support components to be trialled have reported engagement data in an appropriate way, effect sizes have been small-medium to large in magnitude (0.26-3.18) (44-46). To have 95% power (Bonferroni corrected a=0.0125), to detect a small-medium effect size of 0.26, 258 participants are required. To accommodate up to 30% attrition, 336 adolescent and parent/guardian dyads (total n= 672) will be recruited. The dyads will be randomised to 1 of 16 experimental arms (approximately 21 dyads per arm).

Tests of standard ANOVA main effects will compare means computed across aggregates of experimental conditions to identify if each adherence strategy is associated with increases in adherence to the Health4Life app, as measured by our primary outcome measure - the volume of contributions made in the app (i.e., the number of times users self-report a health behaviour or set a goal within the app). For example, the main effect of the text messaging component will be tested by comparing the mean of the outcome variable for the 168 subjects who receive access to gamification content (i.e., those in Conditions 1-8) versus the mean of the outcome variable for the 168 subjects who do not access (i.e., those in Conditions 9-16).

To investigate the usability and acceptability of the different combinations of intervention components, participants will be asked to complete the 10-item System Usability Scale (SUS) at follow-up. This valid and reliable measure is frequently used to assess the usability and acceptability of eHealth programs. The optimal combination of adherence strategies will be identified as the condition containing the greatest number of adherence strategies shown to improve adherence, and none that do not, that also achieves a mean score >68 on the SUS, indicating above average usability and acceptability.

Finally, investigators will analyse the effects of each intervention on CVD risk behaviours. They will conduct tests of standard ANOVA main effects on the number of CVD risk behaviours reported (i.e., more than 2 hours screen time /day; less than 60 minutes of moderate to vigorous physical activity/day; <= 9 hours sleep/night; <5 serves of fruit and vegetables, >1 sugar-sweetened beverage, >1 discretionary food item/day; any alcohol or tobacco use).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/11/2023
Actual
24/02/2024
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
336
Accrual to date
46
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313351 0
Government body
Name [1] 313351 0
Department of Health and Aged Care (Medical Research Futures Fund)
Country [1] 313351 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315219 0
None
Name [1] 315219 0
Address [1] 315219 0
Country [1] 315219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312573 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 312573 0
Ethics committee country [1] 312573 0
Australia
Date submitted for ethics approval [1] 312573 0
21/02/2023
Approval date [1] 312573 0
15/06/2023
Ethics approval number [1] 312573 0
2023/203

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

Contacts
Principal investigator
Name 125138 0
Dr Louise Thornton
Address 125138 0
The Matilda Centre for Research in Mental Health and Substance Use
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Country 125138 0
Australia
Phone 125138 0
+61403744089
Fax 125138 0
Email 125138 0
louise.thornton@sydney.edu.au
Contact person for public queries
Name 125139 0
Louise Thornton
Address 125139 0
The Matilda Centre for Research in Mental Health and Substance Use
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Country 125139 0
Australia
Phone 125139 0
+61403744089
Fax 125139 0
Email 125139 0
louise.thornton@sydney.edu.au
Contact person for scientific queries
Name 125140 0
Louise Thornton
Address 125140 0
The Matilda Centre for Research in Mental Health and Substance Use
Jane Foss Russell Building G02
The University of Sydney NSW 2006
Country 125140 0
Australia
Phone 125140 0
+61403744089
Fax 125140 0
Email 125140 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 principal 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 at louise.thornton@sydney.edu.au.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18659Study protocol  louise.thornton@sydney.edu.au By emailing Dr Thornton, until a planned peer-revi... [More Details]
18660Statistical analysis plan  louise.thornton@sydney.edu.au By emailing Dr Thornton, until a planned peer-revi... [More Details]
18661Informed consent form  louise.thornton@sydney.edu.au By emailing Dr Thornton, until a planned peer-revi... [More Details]



Results publications and other study-related documents

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Documents added automatically
No additional documents have been identified.