Physical activity during pregnancy in women with pre-existing diabetes

Invitation and brief summary

We invite you to join a research study about physical activity during pregnancy in women with Type 1 or Type 2 Diabetes. Before you decide, please read this information to understand the purpose of the study and what it involves.

Purpose and background to the research

This study aims to learn how physical activity changes during pregnancy in women with diabetes and how these changes relate to blood sugar levels and mood.

Being active during pregnancy is important for both mother and baby. It can also help diabetes management. But many pregnant women struggle to stay active, especially those with Type 1 or Type 2 Diabetes.

At the moment, health care professionals can only offer general advice about physical activity in pregnancy. Most of this advice is based on research in women without diabetes. That means it might not meet the specific needs of women with pre-existing diabetes, especially when it comes to managing blood sugar levels during exercise.

We want to better understand how physical activity changes during pregnancy in women with diabetes. We'll also look at how it relates to blood sugar levels and mental health. To do this, we're inviting 175 women to take part, 75 with Type 1 diabetes and 100 with Type 2 diabetes.

What would taking part involve?

If you decide to take part, you'll be asked to sign a consent form to show you understand what the study involves and that you're happy to participate. Here's what you would do:

1. Complete a short questionnaire — You'll answer some questions about yourself and your diabetes.
2. Wear an activity tracker — You'll wear a wrist-worn monitor (like a watch) for seven days at three different points in your pregnancy. This will be posted to you before each seven day wear period.
3. Keep a study diary — You'll note down the exercise you've done over the past week and log any new activity as it happens for seven days at three different points in your pregnancy. This will be done online.
4. Log your meals — You'll take a photo before and after each meal using the FoodView mobile app for seven days at three different points in your pregnancy.
5. Complete a diabetes management questionnaire — After each seven days at three different points in your pregnancy, you'll fill out a short online questionnaire about how you're managing your diabetes.
6. Share glucose data — If you already use a continuous glucose monitor (CGM), we'll ask for your permission to access your data. If you don't use one, we'll provide one that sticks to the back of your upper arm.
7. Return the equipment — You'll return the activity monitor in a pre-paid envelope.

You won't need to change your routine or medication, and you won't need to attend any extra clinic visits.

What are the possible benefits of taking part?

You may not see a direct benefit from taking part, but your involvement will help us understand more about physical activity during pregnancy in women with diabetes. This could lead to better guidance and support for future patients, helping to promote healthier pregnancies.

What are the possible disadvantages and risks of taking part?

We have taken steps to reduce risks. Taking part in this study has minimal risks.

You might experience mild skin irritation from wearing the wrist monitor. We'll give you advice on how to manage this. If it becomes uncomfortable, you can remove it and let us know.

One of the questionnaires includes questions about mood, which might feel sensitive. You can skip any questions or choose not to complete this part. If anything feels difficult, we can guide you to support services.

To ensure your privacy and anonymity, all personal and study data will be stored securely in accordance with University guidelines. Any identifiable information will be stored separately from study data. All study data collected will be anonymised and results will be reported ensuring you cannot be identified.

Will I receive payment for taking part?

You will receive a £10 voucher for each measurement completed as a thank you for your time.

How will we use information about you?

We will need to use information from you for this research project. This information will include:

• Activity data — how much you move during the day and night while wearing the tracker.
• Glucose data — either from your current CGM (with your permission) or from a CGM we provide.
• Questionnaire and diary data — general background information, details about your physical activity, meals, and sleep.
• Your name, address and email address — this is so we can post the activity monitor to you and contact you if required.

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 instead.

The University of Exeter is the sponsor of this research and is responsible for looking after your information. We will share your information related to this research project with the following types of organisations:

• NHS trusts involved in delivering the study
• The University of Exeter research team
• Regulatory bodies (for example, research Ethics Committees, study sponsors)

We will keep all information about you safe and secure by:

• Removing any personal details from questionnaires, study diaries and CGM data.
• Using secure methods to share data within the research team so that no-one outside the study can access it.
• Storing all study data on a secure, password-protected server at University of Exeter that only the research team can access.

Your data will not be shared outside of the UK.

How will we use information about you after the study ends?

Once we have finished the study, 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.

We will keep your study data for a maximum of 10 years. The study data will then be fully anonymised and securely archived or destroyed.

What are your choices about how your information is used?

You can stop being part of the study at any time, without giving a reason, by contacting your clinical team and letting them know. If you choose to withdraw, we will keep the information that has already been collected about you.

You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. You can also object to our processing of your data. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will explain why.

You will have up to two weeks after taking part to request that your data be withdrawn, as long as it has not yet been anonymised. After that point, it will no longer be possible to remove your data from the study, as it will have been anonymised and will not be identifiable.

If you agree to take part in this study, you will also have the option to allow your anonymised data to be used in future research.

Where can you find out more about how your information is used?

• At www.hra.nhs.uk/information-about-patients/
• Our leaflet available from: www.exeter.ac.uk/about/oursite/privacy/research/
• By asking one of the research team
• By sending an email to Holly Jones at [email protected]
• By sending an email to the University of Exeter's Information Governance Manager and Data Protection Officer: [email protected]
• By ringing us on 01392 726621

What will happen to the results of this study?

The results of this study will help us better understand how physical activity changes during pregnancy in women with pre-existing Type 1 and Type 2 diabetes, and how these changes may be linked to blood glucose levels and mental health.

We will share the findings through scientific journals and conferences. Your personal details will not be included in any reports, so you cannot be identified.

After the study is finished, we'll also present the findings at an event held at your local site, where you'll have the opportunity to hear about the results and ask questions if you'd like.

Who has reviewed the study?

All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given a favourable opinion by the East Midlands – Nottingham 1 Research Ethics Committee. It has also been reviewed by the Health Research Authority (HRA) to obtain HRA approval.

This study is part of a PhD research project by Holly Mei Jones, funded by the Economic and Social Research Council through the South West Doctoral Training Partnership.

The University of Exeter is the insurer of this study.