ANZCTR - Registration

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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

24/08/2023

Date data sharing statement initially provided

18/03/2019

Date results information initially provided

11/02/2021

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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Alcohol consumption

Smoking

Sedentary recreational screen time

Physical inactivity

Poor diet

Poor sleep

Condition category

Condition code

Public Health

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Uptake of Alcohol use. Assessed using a single item: “Have you had a full standard alcoholic drink (see alcohol chart) in the past 6 months?” (Yes/No). A pictorial chart will be supplied to assist participants in identifying what constitutes a standard drink in common portions and types of alcohol. 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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Primary outcome [2]

Uptake of tobacco use. Assessed using the item “In the past 6 months, have you tried cigarette smoking, even one or two puffs? (Yes/No), adapted from the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).

Timepoint [2]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Primary outcome [3]

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). Students are also asked a similar item with reference to an “average or typical week”. These items are used to map activity against the Australian 24-Hour Movement Guidelines for Children and Young People (The Australian Government Department of Health, 2019), which recommend that young people aged 5-17 years old engage in at least 60 minutes of MVPA per day.

Timepoint [3]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Secondary outcome [1]

This is a Primary Outcome: Sedentary recreational screen time. Assessed via the International Sedentary Assessment Tool (Prince et al., 2017). Students will be asked to recall the past 7 days and report the amount of time (hours and minutes) typically spent in sedentary activity on weekdays and weekend days. Two items will be used to calculate sedentary recreational screen-time – free time spent sitting, reclining or lying down while i) watching television or videos (including watching TV, DVDs, Netflix or online videos etc) and ii) using an electronic device (e.g. computers, laptops, Xbox, PlayStation, iPads or other tablets, smartphones, YouTube, Facebook or other social media, and the Internet). Respondents are instructed to only report time against their “main activity” if they were simultaneously watching videos and using an electronic device. Students’ average daily screen time will be calculated as a weighted average of weekend and weekday time spent in these two categories of activity combined.

Timepoint [1]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Secondary outcome [2]

This is a Primary Outcome: Sleep duration.
Assessed using the Modified Sleep Habits Survey (Short et al., 2013).

Timepoint [2]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Secondary outcome [3]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention. The primary timepoint is 24-months.

Secondary outcome [4]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [5]

Anxiety symptoms.
Assessed via the PROMIS Anxiety Paediatric Item Bank (Irwin et al., 2010).

Timepoint [5]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [6]

Knowledge of the Big 6. Measured using a 20-item scale specifically developed to reflect the intended content of Health4Life. Items relating to alcohol and tobacco use were adapted from scales used in previous school-based trials (Teesson et al., 2014; Teesson et al., 2017). The scale was derived from a larger pool of items, with user testing among adolescents conducted to condense the scale to 20 items of varying degrees of difficulty. The items assess knowledge of Australian guidelines in relation to physical activity, screen time, sleep, alcohol, and dietary intake; prevalence of alcohol and tobacco use among young Australians; and physical and mental health effects of the Big 6. For each of the 20 statements, students are required to answer “True,” “False,” or “Don’t Know. Scores are summed to produce a total knowledge score.

Timepoint [6]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [7]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [8]

Fruit and vegetable consumption.
Assessed using questions from the NSW School Physical Activity and Nutrition Survey (SPANS; Hardy et al., 2015).

Timepoint [8]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [9]

Daytime functioning (fatigue/alertness).
Assessed via the Pediatric Daytime Sleepiness Scale (Drake et al., 2003) .

Timepoint [9]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [10]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [11]

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?" and frequency of binge drinking (>5 drinks on one occasion) assessed using “How often did you have 5 or more standard alcoholic drinks on one occasion in the past 6 months?”. These items were created specifically for our previous Climate Schools trials (Teesson, Newton et al., 2017; Teesson et al., 2014).

Timepoint [11]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [12]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [13]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [14]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [15]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [16]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [17]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [18]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [19]

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]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [20]

Internalising and externalising symptoms. Assessed using the Strengths and Difficulties Questionnaire (Goodman, 2001).

Timepoint [20]

Measured at baseline and 12-, 24- and 36-months post intervention.

Secondary outcome [21]

Psychological Distress. Assessed using the Kessler 6 (K6; Kessler et al., 2002).

Timepoint [21]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [22]

Adverse childhood experiences. Assessed using three items adapted from the UCLA PTSD Reaction Index, a trauma measure that has been widely used and validated among adolescents aged 7-18 (Elhai et al., 2013; Steinberg et al., 2013).

Timepoint [22]

Measured at baseline.

Secondary outcome [23]

Insomnia. Assessed using the following item developed for this study: "Do you have difficulty falling asleep?". If the participant responds "Yes", they are asked "How severe is this difficulty". Response options include "Mild", "Moderate", "Severe", "Very Severe".

Timepoint [23]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [24]

Parent-set bedtimes. Assessed using the following item developed for this study: "Do you parents set your bedtime on school nights?" (Yes/No).

Timepoint [24]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [25]

Smartphone use before bed. Assessed using two items developed for this study: "What time do you usually stop using your phone in the evening?" and "What is the last app you usually use at the end of the day?".

Timepoint [25]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [26]

Frequency and quantity of tobacco use. Assessed using the items: "During the past 30 days, on how many days did you smoke cigarettes?" and "During the past 30 days, on the days you smoked, how many cigarettes did you smoke per day?", adapted from the Standard High School Youth Risk Behaviour Survey (Centers for Disease Control and Prevention, 2019).

Timepoint [26]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [27]

Alcohol related harms. Students who report drinking alcohol in the past 6 months will complete the Abbreviated Rutgers Alcohol Problem Index (White & Labouvie, 1989). A 6-item scale adapted from the SHAHRP study (McBride et al., 2000) will be used to measure harms caused by others’ use of alcohol.

Timepoint [27]

Measured at baseline, post-test, and 12-, 24- and 36-months post intervention.

Secondary outcome [28]

Active transport. Assessed using the items: "On how many of the past 5 school days did you travel to (or part of the way to) school by walking, cycling or some other form of active transport?", "How long in minutes was the active part of each trip (on average)?", and "How often, during the past 7 days, did you travel from place to place (not including to/from school) all or part of the way by walking, cycling or some other form of active transport?" (Active Healthy Kids Australia, 2016).

Timepoint [28]

Measured at baseline, post-test, and 36-months post intervention.

Secondary outcome [29]

C-reactive protein, Haemoglobin A1c, Triglycerides, Omega-3 index, and AA:EPA ratio assessed, measured via dried blood spot retrieval in a sub-sample of Health4Life participants (Approx. 200) as part of a related sub-study for a PhD project. Participants will be selected from random participating schools in New South Wales, with an aim to recruit even proportions from the intervention and control groups.

Timepoint [29]

Measured 36-months post intervention

Secondary outcome [30]

Anthropometric measurements; height measured with a stadiometer with participants standing barefoot in a sub-sample of Health4Life participants (Approx. 200) as part of a related sub-study for a PhD project. Participants will be selected from random participating schools in New South Wales, with an aim to recruit even proportions from the intervention and control groups.

Timepoint [30]

Measured 36-months post intervention

Secondary outcome [31]

Food frequency questionnaire measured using The Australian Eating Survey (AEQ FFQ) (Watson JF, 2009) The AES FFQ is a validated 120-item FFQ with 15 supplementary questions. The FFQ is designed to collect information about dietary intake over the participants' previous 6 months. It is a semi-quantitative FFQ with a standard portion size provided for each food item and determined using ‘natural’ serving size (eg. slice of bread) where possible, in a sub-sample of Health4Life participants (Approx. 200) as part of a related sub-study for a PhD project. Participants will be selected from random participating schools in New South Wales, with an aim to recruit even proportions from the intervention and control groups.

Timepoint [31]

Measured 36-months post intervention

Secondary outcome [32]

Weight and body fat percentage measured using a Tanita body composition scale in a sub-sample of Health4Life participants (Approx. 200) as part of a related sub-study for a PhD project. Participants will be selected from random participating schools in New South Wales, with an aim to recruit even proportions from the intervention and control groups.

Timepoint [32]

Measured 36-months post intervention

Eligibility

Key inclusion criteria

o Year 7 students attending participating schools in 2019
o Fluent in English
o Parental consent received
o Active student consent provided

Minimum age

11 Years

Maximum age

13 Years

Sex

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 parallel process growth 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. All analyses will be conducted on an intention-to-treat basis, retaining and analysing all students in the groups they were originally allocated. Follow-up exploratory statistical analyses will be carried out to determine whether there is a dose-response relationship between the number of lessons students complete and each outcome. 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

Completed

Date of first participant enrolment

Anticipated

1/04/2019

Actual

1/04/2019

Date of last participant enrolment

Anticipated

Actual

27/09/2019

Date of last data collection

Anticipated

23/12/2022

Actual

31/12/2022

Sample size

Target

7200

Accrual to date

Final

6623

Recruitment in Australia

Recruitment state(s)

NSW,QLD,WA

Recruitment postcode(s) [1]

2000 - Sydney

Recruitment postcode(s) [2]

6000 - Perth

Recruitment postcode(s) [3]

4000 - Brisbane

Recruitment postcode(s) [4]

2300 - Newcastle

Recruitment postcode(s) [5]

2500 - Wollongong

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Paul Ramsay Foundation

Address [1]

Paul Ramsay Foundation
Level 9, 154 Pacific Hwy
St Leonards NSW 2065
Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health Medical Research Council (Early Career Fellowship)

Address [2]

16 Marcus Clarke St, Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney, NSW 2006, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Integrity & Ethics Administration
Research Portfolio
Level 3, F23 Administration Building
The University of Sydney
NSW 2006 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/11/2018

Approval date [1]

17/12/2018

Ethics approval number [1]

2018/882

Ethics committee name [2]

The University of Queensland Human Research Ethics Committee

Ethics committee address [2]

Human Ethics Research Office
Cumbrae-Stewart Building #72
The University of Queensland
St Lucia, QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

14/01/2019

Approval date [2]

05/02/2019

Ethics approval number [2]

2019000037

Ethics committee name [3]

Curtin University Human Research Ethics Committee

Ethics committee address [3]

Research Office at Curtin
GPO Box U1987
Perth Western Australia 6845

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

07/02/2019

Approval date [3]

22/02/2019

Ethics approval number [3]

HRE2019-0083

Ethics committee name [4]

NSW Department of Education

Ethics committee address [4]

State Education Research Applications Process (SERAP)
NSW Department of Education
GPO Box 33 SYDNEY NSW 2001

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

12/02/2019

Approval date [4]

15/04/2019

Ethics approval number [4]

SERAP No. 2019006

Ethics committee name [5]

Catholic Education Diocese of Bathurst

Ethics committee address [5]

Gilmour St, Kelso NSW 2795

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

21/05/2019

Approval date [5]

22/05/2019

Ethics approval number [5]

Nil

Ethics committee name [6]

Catholic Schools Office Diocese of Maitland-Newcastle

Ethics committee address [6]

1/841 Hunter St, Newcastle West NSW 2302

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

07/03/2019

Approval date [6]

07/03/2019

Ethics approval number [6]

Nil

Ethics committee name [7]

Edmund Rice Education Australia

Ethics committee address [7]

23 Lovedale St
Wilston QLD 4051

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

17/04/2019

Approval date [7]

13/05/2019

Ethics approval number [7]

Nil

Ethics committee name [8]

Brisbane Catholic Education Committee

Ethics committee address [8]

243 Gladstone Road, Dutton Park, QLD 4102

Ethics committee country [8]

Australia

Date submitted for ethics approval [8]

12/03/2019

Approval date [8]

15/04/2019

Ethics approval number [8]

373

Ethics committee name [9]

Catholic Education Western Australia

Ethics committee address [9]

50 Ruislip St, Leederville WA 6007

Ethics committee country [9]

Australia

Date submitted for ethics approval [9]

12/04/2019

Approval date [9]

04/06/2019

Ethics approval number [9]

RP2019/07

Ethics committee name [10]

The University of Sydney Human Research Ethics Committee

Ethics committee address [10]

Research Integrity & Ethics Administration Research Portfolio Level 3, F23 Administration Building The University of Sydney NSW 2006 Australia

Ethics committee country [10]

Australia

Date submitted for ethics approval [10]

17/12/2021

Approval date [10]

16/02/2022

Ethics approval number [10]

2022/043

Ethics committee name [11]

NSW Department of Education

Ethics committee address [11]

State Education Research Applications Process (SERAP) NSW Department of Education GPO Box 33 SYDNEY NSW 2001

Ethics committee country [11]

Australia

Date submitted for ethics approval [11]

18/02/2022

Approval date [11]

Ethics approval number [11]

SERAP No. 2022058

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.

In addition, the Health4Life Biomarker Checkpoint will re-recruit a subsample of Health4Life participants (approx. 200) when they are in year 10, to assess any differences in anthropometric measurements, in depth dietary intake, C-reactive protein, and other heart-health biomarkers between intervention groups as part of a related sub-study for a PhD project.

Trial website

https://health4life.org.au/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Maree Teesson

Address

Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9041

Fax

[email protected]

Contact person for public queries

Name

Dr Katrina Champion

Address

Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9041

Fax

[email protected]

Contact person for scientific queries

Name

Dr Katrina Champion

Address

Level 6, Jane Foss Russell building (G02) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 8627 9041

Fax

[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?

De-identified individual participant survey data from all assessment waves (baseline, post-test, 12, 24 and 36 month follow-ups)

When will data be available (start and end dates)?

As per the Health4Life Study authorship and data sharing guidelines, there is an 18-month moratorium after data collection, available for at least 20 years.

Waves 1-4: available from 1st July 2023 until 1st July 2043
Wave 5: available from June 20 2024 until June 20 2044

Available to whom?

Data are potentially available to researchers from not-for-profile organizations, commercial organisations/other and based in any location.
All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted.
The statistical analysis code (syntax) and data collected for the study, including de-identified participant data, will be made available to researchers on request to the corresponding author and with appropriate reason when accompanied by study protocol and analysis plan. Data will be shared after the approval of a proposal by a committee of the current research team with a signed data access agreement. Informed consent forms are available in the published protocol.
For further information, see our data sharing policy (https://www.sydney.edu.au/policies/showdoc.aspx?recnum=PDOC2014/366&RendNum=0).

Available for what types of analyses?

Any type of analysis (IPD meta-analysis, systematic review and other research questions) assessed on a case-by-case basis.

How or where can data be obtained?

As of 1st July 2023, access can be requested via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial.
For further information, see our data sharing policy - https://www.sydney.edu.au/policies/showdoc.aspx?recnum=PDOC2014/366&RendNum=0)

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
17896	Study protocol		https://bmjopen.bmj.com/content/10/7/e035662
17897	Statistical analysis plan		https://bmjopen.bmj.com/content/10/7/e035662
17898	Informed consent form			[email protected]		376728-(Uploaded-16-06-2023-00-36-18)-Study-related document.pdf
17899	Ethical approval			[email protected]		376728-(Uploaded-16-06-2023-00-36-18)-Study-related document.pdf
17900	Analytic code			[email protected]	The statistical analysis code (syntax) and data co... [More Details]
19244	Study protocol	Teesson, M., Champion, K. E., Newton, N. C., Kay-Lambkin, F., Chapman, C., Thornton, L., Slade, T., Sunderland, M., Mills, K., Gardner, L. A., Parmenter, B., Lubans, D., Hides, L., McBride, N., Allsop, S., Spring, B., Smout, S., e Osman, B., & the Health4Life Team. (2020). The Health4Life Initiative: A cluster randomised controlled trial of an eHealth school-based program targeting multiple lifestyle risk behaviours among young Australians. BMJ Open, 10, e035662	https://bmjopen.bmj.com/content/10/7/e035662.long
20118	Data dictionary					376728-(Uploaded-12-07-2023-19-29-48)-Study-related document.xlsx

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details	Attachment
Study results article	Yes	Champion, K.E., Gardner, L. A., McGowan, C., Chapm... [More Details]
Study results article	Yes	Champion, K.E., Chapman, C., Gardner, L.A., Sund... [More Details]
Study results article	Yes	Gardner, L.A., Champion, K.E., Chapman, C., Newton... [More Details]
Study results article	Yes	Gardner, L.A., Debenham, J., Newton, N.C., Chapman... [More Details]
Study results article	Yes	Thornton, L., Brown, H.M., Osman, B., Stewart, C.,... [More Details]
Study results article	Yes	Kim, S., Champion, K.E., Gardner, L.A., Teesson, M... [More Details]
Study results article	Yes	Smout, S., Gardner, L.A., Newton, N., & Champion, ... [More Details]
Study results article	Yes	Leary, M., Pursey, K.M., Verdejo-Garcia, A., Smout... [More Details]
Study results article	Yes	Champion, K.E., Newton, N.C., Gardner, L.A., Cha... [More Details]
Basic results	No		376728-(Uploaded-16-05-2023-21-20-31)-Basic results summary.docx
Plain language summary	No	Is the Health4Life intervention more effective tha... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Lifestyle risk behaviours among adolescents: a two-year longitudinal study of the impact of the COVID-19 pandemic.	2022	https://dx.doi.org/10.1136/bmjopen-2021-060309
Embase	Health4Life eHealth intervention to modify multiple lifestyle risk behaviours among adolescent students in Australia: a cluster-randomised controlled trial.	2023	https://dx.doi.org/10.1016/S2589-7500%2823%2900028-6
Embase	Study protocol of the Health4Life initiative: A cluster randomised controlled trial of an eHealth school-based program targeting multiple lifestyle risk behaviours among young Australians.	2020	https://dx.doi.org/10.1136/bmjopen-2019-035662

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically