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To see what's involved, please read the details about the Paths Project:
The following information describes a behavioural research study and your role in it should you decide to participate. Please read this carefully and do not hesitate to ask any questions now or anytime during the study. Your participation in this study is entirely voluntary. If you decide to participate you will receive a signed copy of this Patient Information Sheet and Consent Form for your records.
NATURE AND PURPOSE OF THIS STUDY
This project aims to test a web-based tailored physical activity program for hospital staff. We will evaluate how acceptable and how effective this program is. If you decide to take part, you will be asked to complete 6 web-based fortnightly sessions. While completing each session you will be asked a series of questions and based on your answers, you will automatically be given personally relevant feedback prepared for you by physical activity experts. This feedback will be presented on the screen and will be supported through text messages if you decide to use text messages. It is not compulsory to receive them; however research shows that they are likely to support you in increasing physical activity. There is a possibility that you will be randomly allocated to the general information program which will not include personalised information but more general physical activity advice.
At the beginning of the study, after study completion at 3 months, and 6 months later, you will be asked to complete questionnaires related to your physical activity, quality of life, stress, sleep quality, and wellbeing. We will also ask you to wear an activity monitor on your upper arm for a week before, after the intervention, and at 6 months, to see if your physical activity changed after the intervention. We will track your web-based activity on the study website using website analytic tools. We want to find out if this web-based intervention is effective in helping people to become more physically active. We also want to explore for whom the intervention works best.
EXPECTED STUDY DURATION AND NUMBER OF PARTICIPANTS
The program will take 3 months to complete with one web-based session every fortnight, final study assessment will take place 6 months after the beginning of the study. We are aiming to recruit a total of 364 study participants from two hospitals in Perth, Australia.
First, we ask you to meet with the study facilitator who will: explain you what this study involves, assess your eligibility and ask you to sign study consent form. At this meeting you will receive an activity monitor to wear on your upper arm for a week; this initial meeting will take approx 10 minutes.
After one week, study facilitator will meet you again, to collect the activity monitor. She/he will ask you to complete study questionnaires, e.g. related to your physical activity and wellbeing and will give you login and password and show you how the web-based program works. The second meeting will take approx 30 minutes. For 3 months after this meeting we will ask you to use the online program (on your laptop, touchpad, smartphone or on computer set up at your workplace), we will ask you to complete one of six sessions every fortnight. This web-based program will provide you with physical activity support and advice that will aim to help you become more active and live more healthy life. Each session will take approx. 15 minutes to complete but you can take more time to go thoroughly through all the information.
After 3 months, once you’ve completed the program, we will again ask you to wear the activity monitor for one week. At the end of that post-program week, we will ask you to meet again with study facilitator to complete similar questionnaires to the ones that you completed at the beginning of the study. We will assess if your answers have changed after the intervention and if your physical activity and wellbeing improved as a result of using the program. Then and throughout the study we will assess which features of the website you liked and which ones you perceived as useful. In this way you will help us to develop a useful and user-friendly program that will help us improve physical activity of hospital employees. This final meeting will take approximately 30 minutes. At 6 months after the initial meeting we will ask you again to complete the set of questionnaires and to wear activity monitor for a week. After that your name will enter into a lottery to win shopping vouchers.
RISKS AND DISCOMFORTS
We are not expecting that you will experience any risks or discomforts while participating in this project. Your participation in this program is voluntary and you are free to withdraw at any stage of the study without giving us any reasons for your withdrawal. We want you to be physically active and we want you to take care while engaging in physical activity. We strongly encourage all necessary precautions while being active.
We are aiming to develop a web-based program that will increase your physical activity, wellbeing and your health. By taking part in this research you are contributing to the development of the science of behaviour change. You are helping us to explore how we can support people to be active, to improve their health and to avoid disease. By being part of this research you may also improve your health and you will receive free expert advice on how to become more active.
Your rights at Australian law do not change upon signing the consent form for this study. The investigator will arrange appropriate medical care should the participant experience an unlikely adverse event.
WITHDRAWAL FROM STUDY
If at any time you wish to withdraw from this study, you are free to do so without prejudice. Please contact the principal researcher Dr Dominika Kwasnicka in case you want to withdraw, you can contact her via email: [email protected] or via phone call: 0892662559. Unless, specifically indicated by you not to do so, we will still analyse your data that has already been gathered. You can but do not need to provide your reasons for your withdrawal.
All data provided by you will be confidential and only study team members will have access to study data. Consent forms will be kept in a lockable filing cabinet belonging to the principal investigator in a lockable office on Curtin University’s Bentley campus. Computerised data spreadsheets will be stored on an encrypted networked drive administered by Curtin University Information Technology Services (CITS) and password-protected with access granted only to the named researchers on the current ethics application. The data will be stored in this way until the data are written up for publication and, thereafter, for 5 years in accordance with the University guidelines. It will not be possible to identify you and your personal data from the study reports and presentations. Once the study is complete a summary of the research results will be available.
INVESTIGATOR CONTACT DETAILS
If you require further information or if you have any problems concerning this project please contact the principal researcher: Dr Dominika Kwasnicka: [email protected] or email: [email protected].
The Hollywood Private Hospital Research Ethics Committee and King Edward Memorial Hospital Ethics Committee have given approval for this study.
If you have any concerns about this study please do not hesitate to contact Chairperson, Research Ethics Committee Hollywood Private Hospital, Monash Avenue, Nedlands WA 6009, telephone: (08) 9346 6345 or the Director of Medical Services at King Edward Memorial Hospital, telephone: (08) 9340 2222, your concerns will be drawn to the attention of the Ethics Committee who is monitoring the study.
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