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Trial registered on ANZCTR


Registration number
ACTRN12619000431123
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
18/03/2019
Date last updated
19/09/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A technology-based program to promote healthy lifestyles among secondary school students
Scientific title
The Health4Life Initiative: Evaluation of an eHealth school-based program targeting multiple chronic disease risk factors among young Australians
Secondary ID [1] 297074 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 311488 0
Smoking 311489 0
Sedentary recreational screen time 311490 0
Physical inactivity 311491 0
Poor diet 311492 0
Poor sleep 311493 0
Condition category
Condition code
Public Health 310127 310127 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention name: Health4Life

Health4Life is an eHealth program that aims to empower adolescents to improve their health and wellbeing and reduce the risk of chronic disease later in life by simultaneously targeting six key lifestyles risk factors: physical inactivity, poor diet, sedentary recreational screen time, poor sleep, alcohol use, and tobacco use.

Participating secondary schools will be randomly allocated to one of two groups. One group will serve as the control group and receive their usual Year 7 health education and the other group with receive the Health4Life intervention. The Health4Life intervention consists of 3 parts:

A) Online classroom lessons (Health4Life school-based program). Part 1 consists of 6 x 20-minute online lessons delivered via interactive cartoon storylines (completed individually by students). Teachers also have the choice of whether to deliver optional activities (e.g. online worksheets, discussion topics, role plays) to their class following the online lesson. These range from 5 to 20 minutes in duration, depending on which, and how many activities, the teacher selects. The program will be delivered during Year 7 health education classes at school (once per week over six weeks). Using principles of social influence and self-determination theories, the intervention aims to provide students with evidence-based information about the Big 6 (e.g. short- and long-term harms, benefits of maintaining good health), improve resistance skills (e.g. to resist peer pressure to smoke or drink), modify existing norms and increase autonomous motivation. Short online quizzes are embedded at the end of each cartoon lesson to test knowledge and reinforce the content. The school-based Health4Life program will be accessed online via the Health4Life study website, and teachers will be provided with links to the syllabus, lesson summaries and curriculum-consistent assessment tasks, and implementation guidelines. No teacher training is required to deliver the Health4Life intervention. However, researchers are available for a one-off meeting with teachers at each school (in group format, approximately 30 minutes) to assist them with navigation of the study website and integrating the program into their lesson plans.

B) Companion smartphone app (Health4Life App). To reinforce the school-based program content and encourage uptake of healthy behaviours, a smartphone app will be implemented in conjunction with the online lessons. Students will be invited to download the Health4Life app onto their smartphones, and to use the monitoring app outside of the classroom to encourage adoption of healthy lifestyle goals. The app will allow students to track their physical activity (e.g. steps per day), sedentary recreational screen time, dietary intake (e.g. servings of fruit/vegetables, sugar-sweetened beverages), abstinence from using alcohol and tobacco, sleep duration and mood. The app includes goal-setting opportunities and provides automated feedback. Student’s will be able to choose how often to use the app. It is anticipated that logging health behaviours should take no more than 10 minutes per day. Students will have access to the app for a 12-month period.

C) Early intervention app for at-risk young people (Health4Life booster). Students who complete the 12- and 24-month follow-up surveys (when they are in Years 8 and 9 respectively), and who indicate engagement in two or more Big 6 risk behaviours at that assessment, will be invited to access additional booster content via the Health4Life smartphone app to encourage behaviour change to reduce their risk. Although the student surveys will be completed in class, the booster app will be used outside of the classroom setting. The app delivers tailored education about the Big 6 risk factors for chronic disease (reinforcing the education provided in the online intervention) and uses cognitive behavioural therapy and motivational interviewing to assist the person to build motivation to change and teach coping strategies to facilitate adoption of health behaviours within their current environment. The app consists of seven 25-minute modules (one for each of the Big 6 risk factors and one module addressing mood). Students will have ongoing access to the booster content over 12 months, with the recommendation that they access it at least once per week until they have completed each module once.

Program Fidelity: Teachers will be asked to complete logbooks to document their implementation of the Health4Life program (i.e. timing, activities delivered, technical problems, other implementation details). Use within the smartphone app will be electronically tracked to assess use of, and engagement with, the application.
Intervention code [1] 313609 0
Prevention
Intervention code [2] 313610 0
Lifestyle
Intervention code [3] 313611 0
Behaviour
Comparator / control treatment
Control schools will implement health education as usual in 2019. All control schools will implement curriculum-based health education during the trial (but will vary in the method of delivery), and this group will serve as an ‘active control’. Teachers will be given participant information statements and consent forms and will be asked to complete an online survey to give details about health education topics and delivery methods used in 2019. Control schools will be offered complimentary use of the intervention at the end of the study in 2023.
Control group
Active

Outcomes
Primary outcome [1] 319021 0
Uptake of Alcohol use. Assessed using the item "Have you had a standard alcoholic drink in the past 6 months?". This item was created specifically for our previous Climate Schools trials (Teesson, Newton et al., 2017; Teesson et al., 2014) and is based on alcohol use items used in the National Drug Strategy Household Survey.
Timepoint [1] 319021 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Primary outcome [2] 319022 0
Uptake of tobacco use.
Assessed using the item "Have you ever tried cigarette smoking, even one or two puffs?", adapted from the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).
Timepoint [2] 319022 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Primary outcome [3] 319023 0
Moderate to vigorous physical activity.
Assessed using the item "Over the past 7 days, on how many days were you engaged in moderate to vigorous physical activity (activity that increases heart rate and gets you/your child out of breath some of the time) for at least 60 minutes? Physical activity can be accumulated over the entire day (e.g., for example in bouts of 10 minutes)" (Active Healthy Kids Australia, 2016).
Timepoint [3] 319023 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Secondary outcome [1] 366739 0
This is a Primary Outcome: Sedentary recreational screen time.
Assessed via the International Sedentary Assessment Tool (Prince et al., 2017).
Timepoint [1] 366739 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Secondary outcome [2] 366740 0
This is a Primary Outcome: Sleep duration.
Assessed using the Modified Sleep Habits Survey (Short et al., 2013).
Timepoint [2] 366740 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Secondary outcome [3] 366741 0
This is a Primary Outcome: Sugar sweetened beverage consumption.
Assessed using the NSW School Physical Activity and Nutrition Survey (SPANS; Hardy et al., 2015).
Timepoint [3] 366741 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.
Secondary outcome [4] 366942 0
Depressive symptoms. Assessed via the adolescent version (PHQ-A; Johnson et al., 2002) of the Patient Health Questionnaire-8 (PHQ-8; Kroenke et al., 2001).
Timepoint [4] 366942 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [5] 366943 0
Anxiety symptoms.
Assessed via the PROMIS Anxiety Paediatric Item Bank (Irwin et al., 2010).
Timepoint [5] 366943 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [6] 367508 0
Knowledge of the Big 6.
A knowledge scale will be developed to reflect the intended content of the Health4life intervention. This scale will be submitted to HREC for approval at a later date, prior to data collection.
Timepoint [6] 367508 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [7] 367510 0
Light physical activity.
Assessed via one item "In the last week, how many times have you walked continuously, for at least 10 minutes, for recreation, exercise or to get to or from places?" (AIHW, 2003).
Timepoint [7] 367510 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [8] 367513 0
Fruit and vegetable consumption.
Assessed using questions from the NSW School Physical Activity and Nutrition Survey (SPANS; Hardy et al., 2015).
Timepoint [8] 367513 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [9] 367521 0
Daytime functioning (fatigue/alertness).
Assessed via the Pediatric Daytime Sleepiness Scale (Drake et al., 2003) .
Timepoint [9] 367521 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [10] 367752 0
Quantity of alcohol use
Assessed using the item "In the past 6 months, how many standard drinks did you have on a typical day when you were drinking alcohol", This item was created specifically for our previous Climate Schools trials (Teesson, Newton et al., 2017; Teesson et al., 2014).
Timepoint [10] 367752 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [11] 367753 0
Frequency of alcohol use
Assessed using the item "How often did you have a standard alcoholic drink of any kind in the past 6 months?". This item was created specifically for our previous Climate Schools trials (Teesson, Newton et al., 2017; Teesson et al., 2014).
Timepoint [11] 367753 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [12] 367754 0
Drinking to excess (>5 standard drinks on one occasion).
Assessed using the item "Have you ever consumed 5 or more standard alcoholic drinks on one occasion?". This item was created specifically for our previous Climate Schools trials (Teesson, Newton et al., 2017; Teesson et al., 2014) and reflects international definitions of 'drinking to excess'.
Timepoint [12] 367754 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [13] 367755 0
Number of cigarettes smoked.
Assessed using the item "During the past 30 days, on the days you smoked, how many cigarettes did you smoke per day?" from the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).
Timepoint [13] 367755 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [14] 368168 0
Future intentions to use alcohol will be assessed using a single item specifically created for our previous school-based trials (Teesson, Newton et al., 2017; Teesson et al., 2014).

Timepoint [14] 368168 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [15] 368169 0
Future intentions to use tobacco will be assessed using a single item specifically created for our previous school-based trials (Teesson, Newton et al., 2017; Teesson et al., 2014).
Timepoint [15] 368169 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [16] 368170 0
Intention to reduce screen time on all or most days of the week in the next three months will be measured using a single item, created specifically for this study.
Timepoint [16] 368170 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [17] 368173 0
Intention to swap energy drinks, soft drinks, sports drinks or cordial for water in the next three months will be measured using a single item, created specifically for this study.
Timepoint [17] 368173 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [18] 368174 0
Intentions to be physically active on all or most days of the week in the next three months will be measured using a single item created specifically for a previous study (Okley et al., 2017).
Timepoint [18] 368174 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.
Secondary outcome [19] 368238 0
Intention to sleep 9-11 hours/night (i.e. meeting national guidelines) on most or all days of the week will be assessed via a single item, created specifically for this study,
Timepoint [19] 368238 0
Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Eligibility
Key inclusion criteria
o Year 7 students attending participating schools in 2019
o Fluent in English
o Opt-out parental consent received
o Active student consent provided
Minimum age
11 Years
Maximum age
13 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
o Schools with less than 30 Year 7 students enrolled in 2019
o Schools based outside NSW, WA and QLD

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 be concealed. Schools will be randomly allocated to groups by an external researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following school recruitment, randomisation, stratifying by state/region and school gender mix (co-educational, predominately male, or predominately female, with the threshold for predominately male or predominately female at >60%), will be conducted by an external researcher using the Blockrand function in R. The randomisation scheme will be weighted by the total pool of available schools per state/region. Specifically, 50% of the total number of schools recruited to the trial will be recruited from New South Wales (with 25% from Greater Sydney and 25% from Other regions: Hunter and Illawarra), while 25% will be recruited each from Western Australia (Perth) and Queensland (Brisbane and Gold Coast). Half of the schools will be randomly allocated to the Health4Life intervention condition, and half to an active control group (Year 7 health education as usual). Cluster randomisation will be used to avoid contamination of the controls by the intervention group through student communication. As is the case for school-based interventions of this kind, students and teachers will not be blind to intervention allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations:
The minimal detectable effect size associated with the health behaviours at the final time point was estimated using power calculations developed by Heo and Leon (2009) for linear mixed regression models taking into account the longitudinal and clustered nature of the data. The alpha level was set at a conservative 0.008 level based on a Bonferroni correction (a=0.05/6) to account for testing of multiple outcomes. Power was set at 0.8, the correlation among level 1 data (repeated measurements over time within student) was set at 0.60 and the number of time points set at 5. The formula described by Heo and Leon (2009) does not require estimates of ICC at the student (level 2) or school (level 3) level. Analysis will be undertaken within each state separately and thus the trial will be powered to detect an effect size in the states with the smallest recruitment numbers. With an anticipated student retention rate of 70% in each school, we need to recruit 100 students from 72 schools (7200 students; 3600 in NSW, with 1800 from Greater Sydney and 1800 from Other regions: Hunter and Illawarra, and 1800 each in WA and QLD) to achieve sufficient power to detect an effect size 0.158. An effect size of 0.158 is based on the targeted behaviour with the lowest anticipated prevalence at baseline, i.e., alcohol use, and is based on our previous online prevention trials.

Statistical Analysis:
Change over time in the multiple health risk behaviours associated with the intervention group, over and above the change in control group, will be compared using multilevel mixed regression models that account for the nesting of repeated measurements within students and students within schools (Curran, 2003). As standard practice, the functional form of change across multiple time points will be empirically tested using linear and quadratic functions as well as piecewise or discontinuous linear growth functions. Models will be compared using chi-square difference tests of model fit. Conditional models will evaluate whether the intervention has a significant effect (using 2-tailed tests of significance) on the change in health behaviours using a time x group interaction. Models will be estimated using robust maximum likelihood estimation to account for any effects of non-normality and non-independence of the outcomes. Missing data will be handled using full information maximum likelihood (assuming missing at random) which yield more efficient, and less biased, parameter estimates than traditional methods of handling missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment postcode(s) [1] 25621 0
2000 - Sydney
Recruitment postcode(s) [2] 25622 0
6000 - Perth
Recruitment postcode(s) [3] 25623 0
4000 - Brisbane
Recruitment postcode(s) [4] 25624 0
2300 - Newcastle
Recruitment postcode(s) [5] 25805 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 301642 0
Charities/Societies/Foundations
Name [1] 301642 0
Paul Ramsay Foundation
Address [1] 301642 0
Paul Ramsay Foundation
Level 9, 154 Pacific Hwy
St Leonards NSW 2065
Australia
Country [1] 301642 0
Australia
Funding source category [2] 301957 0
Government body
Name [2] 301957 0
National Health Medical Research Council (Early Career Fellowship)
Address [2] 301957 0
16 Marcus Clarke St, Canberra ACT 2601
Country [2] 301957 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 301697 0
None
Name [1] 301697 0
Address [1] 301697 0
Country [1] 301697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302364 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 302364 0
Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 302364 0
Australia
Date submitted for ethics approval [1] 302364 0
16/11/2018
Approval date [1] 302364 0
17/12/2018
Ethics approval number [1] 302364 0
2018/882
Ethics committee name [2] 302809 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 302809 0
Human Ethics Research Office
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [2] 302809 0
Australia
Date submitted for ethics approval [2] 302809 0
14/01/2019
Approval date [2] 302809 0
05/02/2019
Ethics approval number [2] 302809 0
2019000037
Ethics committee name [3] 302810 0
Curtin University Human Research Ethics Committee
Ethics committee address [3] 302810 0
Research Office at Curtin
GPO Box U1987
Perth Western Australia 6845
Ethics committee country [3] 302810 0
Australia
Date submitted for ethics approval [3] 302810 0
07/02/2019
Approval date [3] 302810 0
22/02/2019
Ethics approval number [3] 302810 0
HRE2019-0083

Summary
Brief summary
The Health4Life intervention uses web- and app-based technology to improve the physical and mental health of Australian teenagers. Unhealthy behaviours, such as eating poorly, smoking, risky alcohol use and physical inactivity, are known risk factors for serious chronic disease, the leading cause of death worldwide. Previous research has shown that these risk behaviours are well established by late adolescence and commonly co-occur as clusters. It has also been shown that these ‘risk clusters’ are associated with more immediate harms among young Australians, including anxiety, depression and psychological distress.

To address these problems, we developed the Health4Life intervention. The Health4Life study utilises online technology and interactive cartoons to encourage young people to adopt six key health behaviours (“the Big 6”): healthy eating, healthy sleep, physical activity, limiting sedentary recreational screen time and being alcohol and smoke-free. By increasing knowledge and improving skills, this program aims to prevent or improve these behaviours before they become entrenched.

The Health4Life program will recruit 7200 Year 7 students from 72 schools across Australia in 2019. It is anticipated that this intervention will improve both physical and mental health during adolescence, whilst also halting a potential trajectory towards chronic disease later in life.
Trial website
https://health4life.org.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89970 0
Prof Maree Teesson
Address 89970 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 89970 0
Australia
Phone 89970 0
+61 2 8627 9041
Fax 89970 0
Email 89970 0
maree.teesson@sydney.edu.au
Contact person for public queries
Name 89971 0
Dr Katrina Champion
Address 89971 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 89971 0
Australia
Phone 89971 0
+61 2 8627 9041
Fax 89971 0
Email 89971 0
katrina.champion@sydney.edu.au
Contact person for scientific queries
Name 89972 0
Dr Katrina Champion
Address 89972 0
Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006
Country 89972 0
Australia
Phone 89972 0
+61 2 8627 9041
Fax 89972 0
Email 89972 0
katrina.champion@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and aggregated at the school level. IPD will not be available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results