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What is this study about?
Your child is invited to take part in a new research project examining the effectiveness of an innovative digital intervention designed to prevent and modify key risk factors for chronic disease, such as cardiovascular disease, diabetes and cancers. The Health4Life Initiative addresses six key health habits (“the Big 6”): eating healthily, being physically active, sleeping well, limiting screen time, and avoiding alcohol use and smoking. The program aims to improve the physical and mental health of young people in adolescence, whilst reducing their risk of chronic disease in adulthood.
Your child has been invited to participate in this study because their school has agreed to participate. This Participant Information Statement tells you about the research study. Knowing what is involved will help you decide if you want to let your child take part in the research. Please read this sheet carefully and ask questions about anything that you don’t understand or want to know more about.
Participation in this research study is voluntary.
By giving your consent you are telling us that you:
- Understand what you have read.
- Agree for your child to take part in the research study as outlined below.
- Agree to the use of your child’s personal information as described.
You will be given a copy of this Parental Information Statement to keep.
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Who is running the study?
The study is being carried out by the following researchers: Professor Maree Teesson, Dr Katrina Champion, Associate Professor Nicola Newton, Dr Cath Chapman, Dr Louise Thornton, Associate Professor Tim Slade, Associate Professor Katherine Mills, Dr Matthew Sunderland and Dr Lauren Gardner from the University of Sydney, Dr Belinda Parmenter from the University of New South Wales, Associate Professor Frances Kay-Lambkin and Professor David Lubans from the University of Newcastle, Professor Leanne Hides and Associate Professor Judy Bauer from the University of Queensland, Professor Steve Allsop and Dr Nyanda McBride from Curtin University and Professor Bonnie Spring from Northwestern University.
This research is being funded by the Paul Ramsay Foundation and the National Health and Medical Research Council.
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What will the study involve?
Each participating school has been randomly assigned to one of two groups: the Health4Life intervention group or a Control Group. This type of group allocation is called cluster randomisation, which allows for the two groups to be compared over time to evaluate the effectiveness of the Health4Life program. Your child’s school has been randomly allocated to the control group.
If you consent for your child to take part in this research study, they will be asked to complete a confidential online questionnaire which will ask about their current health behaviours, knowledge and beliefs. The survey should take no longer than 30-40 minutes and will be completed during a Personal Development, Health and Physical Education (PDHPE) lesson in Term 3, 2019.
Your child will also be asked to complete the same online survey on four more occasions: approximately 3, 12, 24 and 36-months later (see table below). Your child’s surveys will be linked together over time using a unique code, which will ensure that all the information they provide is confidential.
| Baseline Survey |
Post-Test Survey |
12-mth Survey |
24-mth Survey |
36-mth Survey |
| Term 3 or 4 2019 |
Term 3 or 4 2019 |
Term 3 2020 |
Term 3 2020 |
Term 3 2022 |
| Year 7 |
Year 7 |
Year 8 |
Year 9 |
Year 10 |
If you do not permit your child to take part, they will not complete the research surveys and will be provided with alternative activities, as directed by their teacher. Your child’s school will receive complimentary access to the Health4Life intervention at the end of the study.
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How much of my time will the study take?
Each survey will take no longer than 30-40 minutes to complete. The study will commence in 2019 and continue until 2022 when your child is in Year 10.
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Who can take part in the study?
Year 7 students attending participating schools in 2019 are eligible to take part in this study.
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Does my child have to be in the study? Can they withdraw from the study once they’ve started?
Being in this study is completely voluntary and your child does not have to take part. Your decision whether to let them participate will not affect your/their relationship with the researchers or anyone else at the University of Sydney, UNSW Sydney, the University of Newcastle, the University of Queensland, Curtin University of Northwestern University, now or in the future.
If you decide to let your child take part in the study and then change your mind later (or they no longer wish to take part), they are free to withdraw from the study at any time. You can do so by completing the ‘Withdrawal of Participation Form’ which is provided at the end of this document. If you are receiving this form via email, you can also click the withdrawal link at the end of the email. Alternatively, you can ring the research team and tell them you no longer want your child to participate. Your child’s questionnaire responses can be withdrawn after submission and will not be included in publications, up to the point that we have analysed and published the results.
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Are there any risks or costs associated with being in the study?
We don’t expect the study to cause any harm or discomfort, but if your child experiences feelings of distress because of their participation in this study they can let their teacher know or they can contact a member of the research team (their details are listed below). Alternatively, contact details for services are provided on the Health4Life website and at the end of each survey.
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Are there any benefits associated with being in the study?
We cannot guarantee that your child will receive any direct benefits from being in the study. Each time your child completes a questionnaire for this study, they will be entered into a draw (among students at their school) to win one of two $100 gift vouchers.
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What will happen to information that is collected during the study?
By providing your consent, you are agreeing to us collecting personal information about your child for the purposes of this research study. Their personal information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise.
Your child’s information will be collected via the online questionnaires and apps that are hosted on the Health4Life study website. Data will be stored securely and confidentially, housed on a secure server at the University of Sydney. Before transfer to the server, survey data will be hosted by our web development company on an external server. The external server is based in Australia, and complies with Australian standards in security, ethics, and integrity. Study findings may be published, but your child will not be individually identifiable in these publications.
We will keep the information we collect for this study for a minimum of 20 years, after which time it will be securely disposed. We may use data collected in this study in future projects or for longer term follow-ups of the study cohort. By providing your consent you are allowing us to use your child’s information in future projects. We don’t know at this stage what these other projects will involve. We will seek ethical approval before using the information in these future projects.
We intend to give the information from this project to other researchers so that they can use it in their projects. Before we do so, we will take out all the identifying information so that the people we give it to won’t know whose information it is. The other researchers won’t know that your child participated in the project and they won’t be able to link your child to any of their personal information.
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Can I or my child tell other people about the study?
You are free to tell other people about this study however only students at participating schools will be able to take part.
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What if I would like further information about the study?
If you or your child would like to know more at any stage during the study, please feel free to contact Professor Maree Teesson (Professor, maree.teesson@sydney.edu.au; 02 8627 9041) or Dr Katrina Champion (Research Fellow, katrina.champion@sydney.edu.au; 02 8627 9006). They will happily discuss the study with you further and answer any questions you may have.
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Will I be told the results of the study?
You and your child have a right to receive feedback about the overall results of this study. All participating schools will also receive a summary of the study findings and will be asked to share the results with parents and students. This feedback will be in the form of a one or two-page summary document and will be provided after the study is finished.
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What if I have a complaint or any concerns about the study?
Research involving humans in Australia is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). The ethical aspects of this study have been approved by the HREC of the University of Sydney [2018/882]. As part of this process, we have agreed to carry out the study according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect people who agree to take part in research studies.
If you (or your child) are concerned about the way this study is being conducted or wish to make a complaint to someone independent from the study, please contact the university using the details outlined below. Please quote the study title and protocol number.
The Manager, Ethics Administration, University of Sydney: