Information Sheet

 

Participant Information Sheet 

 UCL Research Ethics Committee Approval ID Number: 15505/005 

 Title of Study: Investigation into the Association Between Hormones Levels, Vitamin D and Sarcopenia in Peri and Post-Menopausal Women  

 Department: UCL Division of Medicine

_________________________________________________________________________ 

Contact Details of the Researcher(s):  

MSc Student – Esra’a Alrabi, Rachel Chataway-Green (esra’a.alrabi.23@ucl.ac.uk), (rachel.chataway-green.23@ucl.ac.uk)  

Honorary Clinical Lecturer. Supervisor and Medical Doctor: Dr Nicky Keay (n.keay@ucl.ac.uk)  

_________________________________________________________________________ 

Name and Contact Details of the Principal Researcher:  

Dr. Adrian Slee, Associate Professor (Teaching) in Nutrition, email: (a.slee@ucl.ac.uk)

_________________________________________________________________________ 

 1- Invitation Paragraph  

You have been invited to participate in a master’s research project related to the topic of menopause, hormone levels and sarcopenia. Before you decide to participate in the study, please read this agreement carefully and ask as many questions as you might have about the project including those about the risks and benefits associated with your participation on it. Please take time to decide whether or not you wish to take part. Thank you for reading this. 

2- What is the project’s purpose? 

The menopause is a physiological condition which all women will experience. Menopause is preceded by the perimenopause, a period of menstruating irregularity which occurs from age 40 years onwards. The transition between perimenopause and menopause is accompanied by hormonal shifts. These hormonal shifts can impact our muscle and are a risk factor for a condition called sarcopenia. Sarcopenia affects the skeletal muscle and can increase the likelihood of adverse outcomes such as falls, fractures, and increase the need for hospital stays, all of which can impact a person’s quality of life. The number of older adults is due to double in the next 25 years, so understanding and identifying women at risk of sarcopenia is an important clinical research topic, which is currently largely understudied.  

The purpose of this study is to investigate any correlation between the stage in the perimenopause journey (as assessed by symptoms and female hormone concentrations or years since the menopause and levels of sex steroid hormones) and sarcopenia prevalence or risk. This study may be replicated using the same women in future projects to track hormonal and sarcopenia throughout the peri and/or menopausal journey.  

3- Why have I been chosen? 

You have been chosen as you are a woman over the age of 45 years.  

4- Do I have to take part? 

It is important for you to know that your participation in this study is voluntary. If you have any questions, please don’t hesitate to ask. If you decide to take part, you will be given this information sheet to keep, and a signed consent form will be given. You can withdraw at any time without giving a reason and without affecting anything. If you decide to withdraw you will be able to withdraw your data up to 4 weeks after the questionnaire is completed. 

5- What will happen to me if I take part? 

The initial study is part of an MSc project (Esra’a Alrabi, Rachel Chataway-Green) and will be undertaken in March-July 2024. If you choose to take part, we will ask you to fill out two questionnaires (phase 1). For phase 2 of the study, if you are (1) not taking hormone replacement therapy and, (2) do not have a chronic condition, you will be invited to have body measurements and muscle function testing performed and dietary analysis on Nutritics. Additionally, participants of phase 1 and phase 2 will be invited to a seminar about “Sarcopenia and female hormone health”. 

 

For Phase 2, measurements will be taken once by researchers during March-July  2024 and should not take more than 30 minutes of your time. Non-invasive body measurements will include your height, weight, body circumferences (e.g. your waist, mid-upper arm and calf/lower leg) and tricep skin fold using callipers. If you do not have any fitted medical devices such as a cardiac pacemaker we would also like to measure your fat mass and lean muscle mass using a bioelectrical impedance device. This is a completely harmless and safe device and uses a small current to estimate your body composition. However, if you think you are pregnant, or have a fitted medical electronic devices, such as a pacemaker, it is contraindicated under this use. We would also like to take some measurements of your muscle strength and physical function. For example, we will ask you perform a ‘sit-to-stand’ test from a chair and use a hand grip strength meter.  

 

If you take part in phase 2 of the testing, medical doctor (Dr Nicky Keay) will contact you by email to request your date of birth and mobile phone number to enter onto the Thriva portal. Thriva is the registered medical company (website: https://thriva.co/) we are using to measure hormone levels (hormones tested: oestradiol, progesterone, testosterone, follicle-stimulating hormone, luteinizing hormone, and Vitamin D) by finger prick blood testing. The Thriva portal is encrypted and password protected, and you will be provided with your personal  login details. (NB: only you and Dr Nicky Keay will have access to the portal.) Thriva will then contact you to obtain your address, in order to send the finger prick blood tests. Once your blood tests results are available, you will be able to see these on Thriva’s secure portal. Thriva are General Data Protection Regulation (GDPR) complaint. The GDPR provides a legal framework for keeping everyone’s personal data safe by requiring companies to have robust processes in place for handling and storing personal information. Please review the Thriva policy online here: https://thriva.co/privacy for further information, and section 10 and 13 below for data privacy.  

6- Will I be recorded and how will the recorded media be used? 

There will be no recording for this study. 

 

7- What are the possible disadvantages and risks of taking part? 

The finger prick blood test might induce a temporary discomfort. 

 

8- What are the possible benefits of taking part? 

Benefits include an overall summary of your results and the study findings. The results from this study may help with future research and understanding of perimenopause, menopause, and sarcopenia risk. You will be contributing data to an under-researched area and supporting future intervention. You will have the opportunity to attend a seminar on “Sarcopenia and female hormone health” 

 

9- What if something goes wrong? 

In the case of any negative issues or eventualities the first point of contact is the main Principal Researcher (Dr Adrian Slee). All issues and concerns will be taken seriously. However, complaints can be reported directly to the Head of UCL Research Ethics and UCL Division of Medicine. Email: ethics@ucl.ac.uk   

 

10-Will my taking part in this project be kept confidential? 

According to the Data Protection Act of UK (1998), the information of the participants of this research will be used in a fairly and lawfully way, and only for purposes of the study. Therefore, only the main researchers will be allowed to access to participants’ information. All data collected will always be protected according to participants’ rights and personal integrity. Hence, all information collected is anonymous and handled in a confidential way, not only during the research but also in the presentation of its results. In order to keep your data safe, your information will be coded to separate your personal identifiable information (e.g., your name, email address) with your measurements (e.g., body composition and nutritional status scores etc). In addition, all files in which your information will be stored will password encryption protected. All data will be stored on internal drive/servers which are password protected. Any kind of publication or dissemination resulting from this study will ensure that all participant information is completely anonymous. There will be special care taken in disguising data that could be traced back to their real identity.  

  

11- Limits to confidentiality 

Confidentiality will be respected subject to legal constraints and professional guidelines. Confidentiality will be respected unless there are compelling and legitimate reasons for this to be breached.  If this was the case we would inform you of any decisions that might limit your confidentiality. 

 

12- What will happen to the results of the research project? 

The results of this research will form part of an MSc dissertation project and potentially future UCL student projects. The results will aim to be disseminated in an anonymised fashion in peer review journals and conference presentations. Furthermore, we also aim to disseminate to the public in the future if we yield important information that has health implications. All of your personal data will be shared with you (results from the questionnaire, body measurements, and blood tests). The final written paper will also be sent out once completed and in the event of publishing, information on how to access this will be sent to you. 

 

13- Data Protection Privacy Notice  

 

The controller for this project will be University College London (UCL). The UCL Data Protection Officer provides oversight of UCL activities involving the processing of personal data, and can be contacted at data-protection@ucl.ac.uk 

This ‘local’ privacy notice sets out the information that applies to this particular study. Further information on how UCL uses participant information can be found in our ‘general’ privacy notice: 

For participants in health and care research studies, click here 

The information that is required to be provided to participants under data protection legislation (GDPR and DPA 2018) is provided across both the ‘local’ and ‘general’ privacy notices. 

The lawful basis that will be used to process your personal data is: ‘Public task’ and ‘research purposes’ will be the lawful basis for processing special category data. 

Your personal data will be processed so long as it is required for the research project. If we are able to anonymise or pseudonymise the personal data you provide we will undertake this and 

will endeavour to minimise the processing of personal data wherever possible. 

If you are concerned about how your personal data is being processed, or if you would like to contact us about your rights, please contact UCL in the first instance at data-protection@ucl.ac.uk 

  

 

14- Who is organising and funding the research? 

      Division of Medicine, UCL 

 15- Contact for further information

 

In case of any question or issue please contact: 

 

 

Thank you for taking the time to reading this information sheet and for considering to take part in this research study. 

 

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