Can I withdraw once I’ve started?
Being in this study is completely voluntary and you do not have to take part. 

If you decide to take part in the study and then change your mind later, you are free to withdraw at any time. You can do this by contacting the research team at sph.activewomen@sydney.edu.au or call (02) 8627 6242.

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If you decide to withdraw from the study, we will not collect any further information from you. Any information that we have already collected, however, will be kept in our study records and may be included in the study results.  If you choose to withdraw, your decision will not have any impact on your current or future relationship with the researchers at the University of Sydney or any other organisations associated with this study. 

 

If you take part in an individual interview, you are free to stop at any stage and you may refuse to answer any questions that you do not want to answer. You can ask for your interview data to be withdrawn by telling the interviewing researcher, or by contacting the research team at sph.activewomen@sydney.edu.au or call (02) 8627 6242. If the data has already been published, we will not be able to withdraw your data.

 

Are there any risks or costs?
While the risks involved with participation in this research are low, there is a slight chance that you may experience muscle soreness when you start a new physical activity program. This risk is taken into consideration by the researchers involved who are experienced with assessing physical activity capabilities and safety precautions advised are consistent with current clinical practice. If you suffer any injuries or complications as a result of this study, you should contact the research team as soon as possible, who will assist you in arranging appropriate medical treatment.

 
There is a slight risk that you may become distressed or concerned by some questions, however, you have the right not to answer any questions in the questionnaires or interviews and leave the response blank.

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The intervention includes health coaching, tailored advice, and goal-setting approaches. Health coaching employs a motivational interviewing approach that acknowledges any barriers you may have to becoming more active, explores the confidence you have about being more physically active and develops individualised strategies that can be implemented. If you happen to experience distress during health coaching, the health professional can  refer you back to your GP if required or to support services such as Beyond Blue (telephone: 1300 22 4636) or Lifeline (telephone: 13 11 14).

The overall cost of time to complete the study components is approximately 20 minutes for each questionnaire (one at baseline and one at 6-months post-randomisation), 5 to 10 minutes for each of the six monthly health diaries, 2 hours total for the health coaching calls, and wearing of the Actigraph activity monitor for at least 10 hours each day over a 7-day period at the start of the program and again 6 months later. If you are allocated to the intervention group, there is an additionally 10 minutes to complete the impressions questionnaire. If you choose to participate in the interview, this is an additional 30 to 40 minutes of your time.

 

There are no financial costs in participating in the Active Women over 50 study nor will you be financially reimbursed for your time. 

Are there any benefits?
While we intend for this research study to further knowledge and improve physical activity levels of women over 50 in the future, we cannot guarantee that you will receive any direct benefits from participating in this study. If the results show a positive effect, the study has the potential to benefit the broader community through the provision of future programs to larger numbers of people in other settings.

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What will happen to the information that is collected?
By providing your consent, you agree to us gathering information about you for the purposes of this study. Your information will be gathered through an online screening form survey, questionnaires, and maybe an audio recording from your participation in an interview, if you choose to be interviewed. Any information you share with us will be stored securely on password protected databases.

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Audio recordings will be used for analysis purposes only. Transcription of the audio recordings will be completed by REV professional transcription service. The audio recordings will be stored on the University of Sydney password protected central research data store network. When ready for transcription, the audio recordings will be transcribed by REV and stored on REV’s secure database in the United States of America while being transcribed. Once transcribed, the audio recordings will be destroyed, and the transcription will be stored on the University of Sydney password protected central research data store network. 

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Your information will only be used for the purposes outlined in this Participant Information Statement, unless you consent otherwise. Identifiable information will be only disclosed with your permission, unless we are required by law to disclose material. We anticipate study findings will be published, but you will not be individually identifiable in these publications. 

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Sharing research data is important for advancing knowledge and innovation. A de-identified set of the data collected in this study may be made available for use in future research. At no time will identifiable data be shared or used without your additional consent. By providing your consent you are allowing us to use your information in future projects. We do not know at this stage what these other projects will involve. We will seek ethical approval before using the information in these future projects.  

What happens when the study ends?
Access to the Active Women over 50 program (health coaching, text message/emails) will cease at the conclusion of the study, but you will still have access to the website and private Facebook group. As part of the study, you will receive advice about being physically active that you can continue to use beyond the study.

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Will I be told the results of the study?
You have a right to receive feedback of the overall results of this study. If you wish to receive a summary of the study findings, please tick the relevant box on the consent form.

 

What if I would like further information?
After reading this information, researchers at the University of Sydney will be available to discuss it with you further and answer any questions you may have. If you would like to know more at any stage, please feel free to contact them. 
•    Call (02) 8627 6242
•    Email the research team at sph.activewomen@sydney.edu.au. 

 

What if I have a complaint or any concerns?
The ethical aspects of this study have been approved by the Human Research Ethics Committee (HREC) of The University of Sydney [2023/803] in accordance with the National Statement on Ethical Conduct in Human Research (2007). 
 

If you have any concerns about the study’s procedures or would like to make a complaint to someone not involved in the study, please contact the University:
Human Ethics Manager
human.ethics@sydney.edu.au
+61 2 8627 8176

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Download a PDF copy of the study information here.