Diabetes Research Project
A team from RCSI Bahrain is conducting a research study to assess the levels of physical activity among people with type 2 Diabetes mellitus over a three-month period.
The study will focus on those aged between 30 and 60 years old with mild-to-moderate type 2 diabetes mellitus, and will require participants to wear a Fitbit activity tracker continuously, in order to monitor their physical activity and sleep patterns for the three month period.
Volunteers will also be asked to complete a simple questionnaire at the beginning, middle and end of the period, and attend a face-to-face interview if invited to discuss what helped or hindered attempts to exercise.
The study is being led by Associate Professor in Physiology, Professor Fiza Rashid-Doubell, in collaboration with fellow members of the Health Professions Education research cluster group and in line with directives from the Ministry of Health.
Principal investigator’s name: Prof Fiza Rashid-Doubell,Associate Professor Physiology - RCSI Bahrain
Co-investigator’s name: Dr Sally Doherty,Senior Lecturer, Psychology, RCSI Bahrain
Co-investigator’s name: Prof Susan Dovey,Professor Epidemiology, RCSI Bahrain
Co-investigator’s title: Dr Declan Gaynor,Senior Lecturer, RCSI Bahrain
Co-investigator’s name: Dr Salim Fredericks,Senior Lecturer, Biochemistry, RCSI Bahrain
Co-investigator’s name: Dr Hani Malik (family physician, MJK Health Centre),Skills coordinator, RCSI Bahrain
Co-investigator’s name: Dr Ebrahim Rajab,Lecturer Biology, RCSI Bahrain
Co-investigator’s name: Dr Wafa Sharabati (Part-time lecturer RCSI, Bahrain),Director of Health Promotion, MOH
Why is this study being done?
Physical activity is an important factor in reducing complications from type 2 Diabetes mellitus. The lack of data on the amount of exercise being done by adults in Bahrain has led to the focus of this pilot project, which is to assess the amount of exercise done by adults with and without type 2 Diabetes mellitus by asking you to wear a physical activity tracker. We will also use a questionnaire (SF-36) to assess 8 core health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health three times over the three month period. We also want to understand the enablers and barriers to exercise at the end of the 3 months by inviting you to attend an interview to discuss your experiences
Who is organising and funding this study?
This research study is being conducted by the investigators named on the first page who are either full or part-time academic staff from RSCI Bahrain. The lead on this project is Professor Fiza Rashid-Doubell. There is also a medical doctor from your Mohammed Jassim Kanoo (MJK) health centre in Bahrain who is part of the research investigation team (Dr Hani Malik). This research is being funded by an internal RCSI Grant.
Why am I being asked to take part?
You have been invited to take part in the research study because you satisfy the requirement of being a participant with mild to moderate type two Diabetes mellitus and you are aged between 30-60 years attending the Mohammed Jassim Kanoo health centre. We are also asking individuals who don’t have type two Diabetes mellitus and are aged between 30 and 60 years-old to join a control group who will also receive physical activity trackers over a 3 month period. There will be 30 in each group: type two Diabetes mellitus and non-type two Diabetes mellitus, so 60 participants in total.
How will the study be carried out?
The study will be conducted in three parts. The first part is an invitation to participate this will come from your doctor if you match the inclusion criteria. They will provide you with an information leaflet with a brief outline of the study and contact information for the research assistant if you’re interested in participating. Recruitment and consent: once you have contacted the research assistant to express an interest in participating they will send you a copy of the participant information leaflet (this form) to read as well as a date and time to meet you to answer any questions you have about the study. Once you are happy to participate they will provide you with a consent form to complete and sign. Study itself: we will give you and will require you to wear a physical activity tracker termed ‘Fitbit’ for 3 months, all the time, even if you’re not doing any exercise. At the start, middle and end of the study (0 weeks, 6 weeks and 12 weeks) you will be asked to answer the SF-36 questionnaire consisting of 36 questions relating to your self-assessment of your health, physical activity, emotional well-being and quality of life. This will be done at the health centre at mutually convenient time for you, probably during one of your health centre visits. At the end of the 3 month period we will invite you for a debriefing to share some of the study results with you and at that time invite you to attend an interview to help us understand what helped and hindered you’re attempts to do exercise over the three month period. Again you will be invited to attend the health centre for the interview at the end of the three month study period.
What will happen to me if I agree to take part?
You will be invited, recruited and consented as described in section above (how will the study be carried out?). Physical activity tracker will be given to you. You will have to wear the device all the time, this is really important. The device is monitoring your personal physical activity, don’t give the device to anyone else to wear, as this will affect the results of the study. You can take it off when you are bathing, swimming or if the device needs recharging, this takes about an hour. Other than these two occasions you will need to wear the physical activity tracker all the time even when you’re sleeping. Along with the device we will be given a unique identification code which is assigned exclusively to you and only the research assistant have access to the information of your demographics associated with the unique identifier code such as the email assigned to you device and your age, gender, whether you have T2DM or not. This information will be stored on a laptop separate from the one used by the main investigator of the research study. The research assistant will also give you some information on how to use the device and setup the necessary Fitbit account online with some of your personal data (gender, year of birth, height and weight). You will also be instructed on how to install the Fitbit application on your personal mobile phone or personal computer which will allow you to sync your device with the designated Fitbit account.
Once you have been assigned the device you will be asked to complete the SF-36 questionnaire and a few additional questions at the start and writing your unique identification code (providing you with anonymity) where it asks you for your name. You will be asked to complete the same questionnaire twice more, after 6 weeks (you will be sent a reminder to meet at the health centre to complete the questionnaire via WhatsApp) and at the end of the three months (another reminder sent via WhatsApp).
At the end of the 3 month period we will invite all participants to the health centre for a debriefing (via WhatsApp) where we will share with you our preliminary data. We will also ask you if you would like to attend a face-to-face interview to discuss what helped you or hindered your attempts to exercise with one of the study investigators at a time and date which is suitable for you at the health centre. The interviews will be audio-recorded.
All your physical activity data will be collected in the designated Fitbit account created for the purposes of this study only. None of your personal identifying information will be added to this Fitbit account. Your data and the data of all other participants will be aggregated by Fitabase, which is an online service used for research studies of this nature. The research assistant will download all participants’ activity data from Fitabase at the conclusion of the 3-month study. The research assistant will provide you with a copy of your activity data for your own use before it is deleted from the Fitabase service. The de-identified physical activity data of all participants will be analysed and stored on a secure server.
De-identified questionnaire responses will be analysed and stored electronically on a secure server.
Participants who contribute to an interview will have their interview transcribed and both the transcript and the audio will be stored in the office of the principal investigator in a password-secured laptop for both the transcripts and audio–recordings.
The audio recordings will be written out in full (transcribed verbatim) and these notes and the audio-recordings will be kept on a password protected computer held by one member of the research team. Participants who contribute to an interview to this study have the right to request for their recording to be removed from the study at any time as well as their transcripts. In any report on the results of this study, this data will be anonymised and spoken of in general terms.
Yes it is. We do not record any identifiable information, such as your name or address, so your participation is anonymised. You cannot be identified by the researchers once your participation is over since your identifying information will be anonymised by replacing it with a unique identifier code used only for the purposes of the research study. We will keep the information you provide for 7 years, in line with RCSI guidelines on data protection. Your responses will be recorded on an audio recorder and analysed in RCSI by the research team. We hope to publish the anonymised results in medical journals and at scientific conferences. We will keep the anonymous data for future research studies that are approved by the RCSI Research Ethics Committee.
The benefits for those who participate may be improvements in your quality of life and in your physical activity as well as improved emotional well-being. We hope that the physical activity tracker should act as an incentive to promote physical activity, the data captured daily should motivate you to improve your daily amount of physical activity. It is hoped that the physical activity tracker will help you develop an awareness of the amount of exercise done over the three month period.
Having to wear the physical activity tracker may help study participants raise their awareness on the amount of physical activity they do on a daily basis. Helping them build up a picture of the amount of physical activity done over the three-month study period.
In addition, if you manage to complete the three month study by wearing the device continuously and completing the SF-36 questionnaire at the three designated time points over the three month period as well as attending the final debriefing then you will be eligible to keep the physical activity tracking device for your own personal use.
Your doctor has considered you eligible to participate in this study and therefore having minimal risk from any aspects involved in the study. There are no obvious risks to you. We will try and schedule our meetings when you come in for your regular clinic appointment giving you an opportunity to have your usual discussion with your doctor about your health status.
Where can I get further information?
If you have any questions about the study or you want to opt out of the study, or require further information. Please contact:
Prof Fiza Rashid-Doubell (principal investigator)
Contact email: firstname.lastname@example.org