Additional Information and Data Privacy Notice

If you have a concern about any aspect of this study, you should ask to speak to the study team at the University of Birmingham Clinical Trials Unit who will do their best to answer your questions. If you remain unhappy and wish to complain formally, you can do this by contacting National Health Service complaints mechanisms, this is usually the Patient Advisory and Liaison Service (PALS). NHS PALS Service.

In the event that something does go wrong and you are harmed during the study, and this is due to someone's negligence then you may have grounds for legal action for compensation against Birmingham Community Healthcare NHS Foundation Trust but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).

Once the study has finished, we may publish the findings in a journal.

We will need to use information from you for this research project. The Birmingham Clinical Trials Unit, Loughborough University and University of Leicester will process personal data. This information will include your name, date of birth (DOB), gender, home address, ethnicity, marital status, employment status, household income and your healthcare professional’s contact details e.g. your GP surgery (if applicable). People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number (participant ID number) instead and we will keep all information about you safe and secure.

If you are randomised to the Snacktivity group, your first name, last name, age, and gender will be preloaded onto the SnackApp by the research team. A Fitbit profile will also need to be created for you using your participant ID number, DOB and gender. Your daily physical activity data will be collected from the study app (SnackApp) and stored to help us understand your physical activity patterns. This information and details about how you use the app will be stored by the phone and sent wirelessly to a dedicated encrypted server that is based in the UK (London) and are Google servers managed by Cuttlefish Multimedia. All data will be stored centrally in a secure database and your personal information will be stored separately from any of the other data. A copy of your completed consent form will be sent to your GP to inform them of your participation in the study. Short message service (SMS) text messages will be sent to you via FireText, an Online SMS platform which will be programmed into our trial database. In order for us to use the service we will need to provide your name and mobile phone number to FireText to allow them to send the message to you, your data is held in line with GDPR.

Once we have finished the trial, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

You can find out more about how we use your information at:

• www.hra.nhs.uk/information-about-patients/
• by asking one of the research team: snacktivity@trials.bham.ac.uk
• by sending an email to the co-sponsors data protection officers: dp@lboro.ac.uk or bchc.dpo@nhs.net

If you would like further information about how health researchers use information from participants please visit http://www.hra.nhs.uk/patientdataandresearch

As defined by General Data Protection Regulation (GDPR), some of the personal data which will be collected from you is categorised as “sensitive data” (e.g. your name and contact details). The processing of these data is necessary for scientific research in accordance with safeguards. This means that the study has been through an ethical committee to ensure that the appropriate safeguards are put in place with respect to the use of your personal data. Personal data will be processed on the public task basis. Individuals’ rights to erasure and data portability do not apply if you are processing on the basis of public task. However, individuals do have a right to object.

Your data will be retained by the study team and LU for 25 years after the completion of the research in line with the study office and Loughborough University’s Policy. The research team will seek approval from BCHC and LU as co-sponsors of the study before the deletion of data. Your anonymised data may be used in other ethically approved health studies.

If you require any further information regarding the General Data Protection Regulations, please see: https://www.birmingham.ac.uk/research/bctu/data-protection.aspx. If you have any further questions about the research, please contact the study team.