Part 1 What does my participation involve?
1 What is the purpose of this research?
We are seeking to evaluate whether the addition of a daily online Food Exercise Sleep Stress questionnaire that focuses on broad and simple habits around these key areas is helpful to support lifestyle change to support people’s health. A key part of exercise physiology service is to help people adopt good health habits around physical activity and other areas like eating, sleeping and managing stress. Improvements in these areas can be very important for managing chronic illness and recovering from shorter-term illness or injury. Previous research has shown that online tools can help people to make positive changes to their health behaviours. We are interested to know if the use of this daily questionnaire can support people to make these changes while they are working with their Exercise Physiologist.
The lead researcher, Associate Professor Kade Davison, is an Exercise Physiologist at the University of South Australia. All investigators are listed at the end of this sheet. The University of South Australia is conducting this research in conjunction with the iNform Research institute and your Exercise Physiologist.
2 What does participation in this research involve?
After reading the information sheet, if you are interested, believe you are eligible, and wish to be contacted by researchers to learn more about the study, please let your Exercise Physiologist know. Alternatively, you could contact the project coordinator via email (Bethany.Gower@unisa.edu.au). To be eligible for the study, you need to be:
• Currently accessing an exercise physiology service and are likely to continue with this for at least four more weeks
• Able to read and write in English.
• Able to access the internet and feel confident to open and close web browser windows and receive emails.
• Provide written informed consent.
Once your enrolment in the study has been confirmed, you will be asked to organise a time to meet with researchers. If possible, this can be organised around your exercise physiology consultations to save travel time. Researchers will be able to answer any further questions you may have, and at this time, you will be asked to complete a short questionnaire on the day. You will then be asked to complete a short baseline questionnaire once a day for three days via an email link. This will take about five minutes each day.
Allocation
From there, you will be randomly split into one of two groups, to either access the Food Exercise Sleep Stress questionnaire daily or access to the Food Exercise Sleep Stress questionnaire on three days per week (two weekdays and one weekend day). This is because you will be participating in a feasibility pilot study.
The Daily Food Exercise Sleep Stress questionnaire Group
This group will receive access to the daily Food Exercise Sleep Stress questionnaire for 12 weeks which will be accessible via email. You will be shown how to use the tool and receive an instruction booklet to provide further information. After the 12-week intervention has been completed, you will still have access to the questionnaire (for up to 12 months) if you wish to continue to use it. In total, the time commitment for this project is up to 5 minutes to complete the questionnaire each day. If you are not interested to continue completing the questionnaire each day that is okay, but we ask that you please complete the final three days at the end of the 12 months.
The Food Exercise Sleep Stress questionnaire three days per week Group
This group will receive access to the Food Exercise Sleep Stress questionnaire on three days per week for 12 weeks which will be accessible via email. You will be shown how to use the tool and receive an instruction booklet to provide further information. After the 12-week intervention has been completed, you will still have access to the questionnaire (for up to 12 months) if you wish to continue to use it. In total, the time commitment for this project is up to 5 minutes to complete the questionnaire per day you are prompted to complete the survey (i.e. up to 15 minutes per week). At the end of the study, both groups will complete follow-up assessments (the same five-minute questionnaire).
Additional Subgroup study
Researchers are also looking to determine how valid different sections of the Food Exercise Sleep Stress questionnaire are compared to recognised physical activity, sleep, and well-being measurement tools. If you are interested, you have the option to also participate in the validation testing of two or more different sections of the questionnaire. This is entirely optional and is in addition to your participation in the Food Exercise Sleep Stress questionnaire. These subgroups will all be completed within the first three weeks of the study.
1 Exercise subgroup
a. You will be asked to wear a small device (accelerometer) on your wrist for five days. It will measure your physical activity levels. It is comfortable, lightweight and waterproof. It will take about 20 minutes to set you up with the device there is no additional time commitment beyond that.
b. You will also be asked to complete a short questionnaire on the last day of your physical activity tracking.
2 Sleep subgroup
a. The sleep subgroup will be assessed by one questionnaire, which usually takes 5-10 minutes to complete.
3 Well-being subgroup
a. You will be asked to complete a short questionnaire to assess your well-being on three consecutive days.
There are no additional costs associated with participating in this research project, nor will you be paid for your time.
3 Other relevant information about the research project
The project is being conducted by researchers in exercise and behavioural science from the University of South Australia and the iNform Health Research Institute. Participants will be recruited from exercise physiology services at the Queen Elizabeth Hospital, Hampstead Rehabilitation Centre, GP Plus Elizabeth, the University of South Australia, iNform Health and Fitness Solutions and Fleurieu Exercise Physiology clinics. The aim will be to recruit at least 68 participants across the six sites.
4 Do I have to take part in this research project?
Participation in any research project is entirely voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your routine treatment, your relationship with those treating you or your relationship with the Exercise Physiologists working with you. If you do decide to take part, you will be given this Participant Information and Consent Form to sign, and you will be given a copy to keep.
5 What are the alternatives to participation?
As the questionnaire is novel, there are no current alternatives to participation. However, all the information presented is from evidence-based publicly available information.
6 What are the possible benefits of taking part?
We cannot guarantee or promise that you will receive any benefits from this research; however, possible benefits may include increased awareness of what specific behaviour can be completed with the aim of improving your health and well-being. When completing the Food Exercise Sleep Stress questionnaire, you will have the option of sharing your questionnaire feedback with your Exercise Physiologist or other treating health professional if you wish to have additional personalised support, accountability, and education.
7 What are the possible risks and disadvantages of taking part?
There is a minimal risk of harm or injury. Some participants may experience some muscle pain or soreness if they choose to become more physically active. As they are also undertaking services with an Exercise Physiologist, we believe this risk will be negligible. Completing the baseline, daily Food Exercise Sleep Stress questionnaire, and follow-up questionnaire may place a small time burden on participants. Getting to the initial face-to-face screening may result in participants’ travel costs. It is possible that the participants may experience negative emotions (e.g. frustration) when using the online questionnaire if there are unexpected usability issues.
8 Can I have other treatments during this research project?
While participating in this research project, you can continue all of your other treatments. You can also begin any new therapies your health care team prescribed to you.
9 What if I withdraw from this research project?
Your participation in this study shall not affect any other right you may have to compensation under common law. If you do consent to participate, you may withdraw at any time. If you decide to withdraw from the project, please notify a research team member before you withdraw. A research team member will inform you if there are any special requirements linked to withdrawing. If you do withdraw, you will be asked to complete and sign a ‘Withdrawal of Consent’ form; this will be provided to you by the research team.
If you decide to leave the research project, the researchers will not collect additional personal information from you. However, personal information already collected will be retained to ensure that the research project results can be measured properly and to comply with the law. You should be aware that data collected up to the time you withdraw will form part of the research project results. If you do not want your data to be included, you must tell the researchers when you withdraw from the research project.
10 Could this research project be stopped unexpectedly?
This research project may be stopped unexpectedly for a variety of reasons. These may include reasons such as difficulty recruiting individuals to participate or the behaviour change tool is shown to have unexpected risks.
11 What happens when the research project ends?
As researchers invested in improving the long-term health for individuals undergoing exercise physiology services, it is important to us that our tool is thoroughly tested before making it publicly available. This is to ensure it is both safe and effective before promoting it. As such, access to the tool may be restricted at the end of the study for research or quality improvement purposes. We will send all participants a brief summary of our study findings and our plans for the tool at the end of the study.
Part 2 – How is the research project being conducted?
12 What will happen to information about me?
By signing the consent form, you consent to the research team collecting and using personal information about you for the research project. Any information obtained in connection with this research project that can identify you will remain confidential. All information will be stored on a University of South Australia password-protected network drive for a minimum of five years post study completion. Your privacy will be protected by being provided with an ID number at the start of the study. This ID number will be used to identify you and link your data rather than your real name. No identifying information will ever be published about you. All data will be published and discussed in an aggregate format only (e.g. the average increase in physical activity across all participants).
In accordance with relevant Australian and/or South Australian privacy and other relevant laws, you have the right to request access to the information about you that is collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please inform the research team member named at the end of this document if you would like to access your information. The research results will contribute to coursework assessment items for seven students completing a Bachelor of Clinical Exercise Physiology (Honours) award at the University of South Australia (Shae-Lea Partington, Mahima Bedi, Janis Onuzans, Hannah Burgess, Jemma Ekers-Broadbent, Leah Verbis, and Keely Clark).
13 Complaints and compensation
If you have questions or problems associated with the practical aspects of your participation in the project or wish to raise a concern or complaint about the project, you should consult the University of South Australia Human Research Ethics Committee, on (08) 8302 6330 or humanethics@unisa.edu.au. Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome. If you suffer any distress or injury due to this research project, you should contact the research team as soon as possible.
14 Who is organising and funding the research?
This research project is being conducted by the University of South Australia by Associate Professor Kade Davison in collaboration with a local Exercise Physiology practice (iNform Health and Fitness Solutions) that have created the Food Exercise Sleep Stress questionnaire. It should be noted that industry members of the broader research team Mr Max Martin and Dr Nathan Harten have a commercial interest in the Food Exercise Stress Sleep questionnaire. To support this work they have provided funding to the University of South Australia to engage administrative support to assist in running the project. To manage the conflict of interest they will not have any direct role in the collection or analysis of research data.
15 Who has reviewed the research project?
All research in Australia involving humans is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research project have been approved by the HREC of Central Adelaide Local Health Network. This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.
16 Further information and who to contact
The person you may need to contact will depend on the nature of your query. If you want any further information concerning this project or if you have any medical problems which may be related to your involvement in the project (for example, any side effects), you can contact any of the following people:
Research contact person
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact the project co-ordinator (Bethany Gower) at: Bethany.Gower@unisa.edu.au
Reviewing HREC approving this research and HREC Executive Officer details:
| Reviewing HREC name | University of South Australia Human Research Ethics Committee |
| Telephone | 08 8302 6330 |
| humanethics@unisa.edu.au |
Any complaint or concern will be treated in confidence and fully investigated. You will be informed of the outcome.
