'Investigating associations between stages of menopause, alcohol use and wellbeing: a longitudinal study.'

This research will help us better understand women's health during the menopausal transition, which can be used to inform better health support and treatments. Your participation in this study is completely voluntary and your responses will be strictly confidential.

If you have questions at any time about the survey, you may contact Madeline Rowe at m.rowe@2023.ljmu.ac.uk

The next section will provide more detail about the study. After reading it, and if you are happy with it, please continue to the consent form.

Thank you, your participation is greatly appreciated!

PARTICIPANT INFORMATION SHEET

Research Ethics Committee Reference Number: 23/PSY/072

Title of Study: Investigating associations between stages of menopause, alcohol use and wellbeing: a longitudinal study.

You are being invited to take part in a research study. You do not have to take part if you do not want to. Please read this information, which will help you decide.

1. What is the purpose of the study?

This study aims at answering the following question: What is the role of alcohol in women’s lives as they transition through menopause? As such, this study will investigate the associations between alcohol consumption, menopause stages and symptoms, wellbeing, and the factors that affect these associations over time. This study is part of a larger PhD project.

2. Why have I been invited to participate?

You have been invited to participate as we believe you meet our criteria:

- Born female (assigned female at birth), and identify as a woman

- Between 40 and 65 years old

- Consume 10 or more units of alcohol weekly. You can refer to the image below to give you an idea of units and what they mean.

- Speaking English fluently

- Not pregnant

Figure1: NHS Alcohol Unit Reference Scale (https://www.nth.nhs.uk/live-well/alcohol/know-your-units/)

2. Do I have to take part?

No. You can ask questions about the research before deciding whether to take part. If you do not want to take part that is OK.
You can stop being part of the study at any time, without giving a reason. You may withdraw from the study by contacting us or simply by stopping answering the questionnaires (quitting the browser).
We can erase any information we will have collected at your request, by email, up to 10 days after you have finished the study. After this, your data will have been processed, anonymised, and combined with others participants’, meaning we will not be able to identify and remove your data.

3. What will happen to me if I take part?

Once you have read this participant information sheet and signed the consent form, you will be seamlessly redirected to the beginning of the first survey. This will take around 21 minutes to complete, and will ask you for some demographics and information on your current menopausal symptoms, drinking behaviour, health, and wellbeing.
After this, you will receive on Prolific the link to the future surveys, every 2 weeks for 6 months (12 surveys in total). These surveys will also ask about your menopause symptoms, drinking behaviour, health, and wellbeing. However, these are shorter and should only take about 12 minutes to complete.
We’re requesting you fill in the survey over 6 months because there are important changes over time in terms of menopause symptoms and wellbeing. We are interested in understanding how alcohol use changes across time, and whether there are associations between symptoms, wellbeing and drinking behaviour.
In the first survey only, you will also be asked demographic information such as your age, ethnicity, education, level of income, area of residence, and menopause stage/treatment. This is so we can look at menopause symptoms and drinking behaviour in women from different backgrounds.

4. Are there any potential risks in taking part?

Participating in the research is not anticipated to cause you any disadvantages or discomfort. The potential physical and/or psychological harm or distress will be the same as any experienced in everyday life.
Questions included in this study require participants to reflect on their wellbeing. If you feel worried or have low mood, we would like to point out that there are several sources of advice or help which are free and readily available to you and which may be useful. Specifically, these include:
-Mental health support:
Samaritans (https://www.samaritans.org/)
Mind (https://www.mind.org.uk/)

-Alcohol use:
Alcohol Change UK (https://alcoholchange.org.uk/help-and-support/get-help-now),

-Menopause:
NHS menopause page (https://www.nhs.uk/conditions/menopause/help-and-support/)
Balance (https://www.balance-menopause.com/)
If participation in this study has negative effects on you, please seek help and advice from support services such as your GP or the aforementioned resources.

5. Are there any benefits in taking part?

There will be no personal benefit to you from taking part in this study.
The potential benefits of this study would be for wider society; to better understand women’s experience of menopause. There is very little research on women’s health, especially the influence of alcohol on women’s wellbeing during menopause. We hope that the information gathered in this study will help other researchers and healthcare professionals develop women-specific evidence and support to improve women’s health and wellbeing.

6. Payments, reimbursements of expenses or any other benefit or incentive for taking part:

You will be entered into a prize draw to win Love2Shop vouchers, the more you complete surveys the higher chances you have to win one of the following:
-1 x £50
-2 x £25
-5 x £10

7. Payments, reimbursements of expenses or any other benefit or incentive for taking part:

For each completed survey, your unique code will be entered into a prize draw. At the end of the study, codes will be randomly selected. There are two prizes of £50, three prizes of £25, five prizes of £10. So, the more surveys you complete, the higher the chances of winning. Winners will be sent Love2Shop vouchers for the amounts available.

8. What will happen to information/data provided?
The information you provide as part of the study is the study data. Any study data from which you can be identified (e.g. from identifiers such as your name, date of birth, audio recording etc.), is known as personal data. Your participation in this study will involve the collection/use of personal data. The study data collected/used will include more sensitive categories of personal data (special category personal data) such as your race; ethnic origin; politics; religion; genetics; health; sex life; or sexual orientation.
We will keep personal data safe and secure. Only people from the research team and potential external examiners can access your data.

The personal data collected will include:
• Email address - with your agreement, we would like to store your email address to send you reminders for the surveys, and so that you may be contacted about future opportunities to participate in research studies.
• A record of consent.
• Study data - we will use a code so that you cannot be directly identified from the data.
Study data, records of consent, and email addresses will be kept for three years after the study has finished – maybe longer as determined by funding or publisher requirements.
We will not attempt to capture the IP address or any other information that is not voluntarily provided.
When publishing the results of this study (e.g. in a journal article) anonymised datasets may be submitted to an online data repository in accordance with good research principles.

9. Who is organising and who is funding/commissioning the study?

This study is organised by Liverpool John Moores University.

10. Whom do I contact if I have a concern about the study or I wish to complain?

If you have a concern about any aspect of this study, please contact Madeline Rowe or Dr Abi Rose, and we will do our best to answer your query. You should expect a reply within 10 working days.
f you remain unhappy or wish to make a formal complaint, please contact the Chair of the Research Ethics Committee at Liverpool John Moores University who will seek to resolve the matter as soon as possible:

Chair, Liverpool John Moores University Research Ethics Committee;
Email: FullReviewUREC@ljmu.ac.uk;
Tel: 0151 231 2121;
Research Innovation Services, Liverpool John Moores University, Exchange Station, Liverpool L2 2QP

11. Data Protection

Liverpool John Moores University is the data controller with respect to your personal data. Information about your rights with respect to your personal data is available from:
• https://www.ljmu.ac.uk/legal/privacy-and-cookies/external-stakeholders-privacy-policy/research-participants-privacy-notice
• by asking one of the study team or contacting us using the information below

12. Contact details

Principal Investigator: Madeline Rowe - LJMU postgraduate research student
LJMU Email address: m.rowe@2023.ljmu.ac.uk
LJMU School/faculty: Faculty of Health – School of Psychology
LJMU Central telephone number: 0151 231 2121

Supervisor Name: Dr Abi Rose
LJMU Email address: a.k.rose@ljmu.ac.uk

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