Participant Information Sheet Version/Date: 1. 1 , 31/01 /202 3 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 1 of 7 ARIADNE stud y – Key points Central University Research Ethi cs Committee (CUREC) reference: R82152/RE002 Who is this study for? Adults diagnosed with type 2 diabetes in the last 6 years What will I have to do? You will have a 50 - 50 chance to be in one of two groups: Control Carry on as normal Intervention Follow a weight loss programme OR Complete questionnaires online (15 - 20 minutes ) 6 times over 1 year Measure your weight at home We will give you a scale if you don’t have one. What checks are involved? We will ask you to measure at home and tell us your Weight Blood sugar (if necessary) Blood pressure (if necessary) as well as your Medication + a one - off blood sample using a finger - prick test kit at home (intervention group only) What is the weight loss programme being tested? A weight loss programme shown to help people with type 2 diabetes : lose weight reduce their medication What does the weight loss programme involve? Eat only soups , shakes, and bars (formula products) for 12 weeks These include all the vitamins and minerals that are essential for goo d health, but only few calories We will give you for free all the se products Between weeks 13 and 21, you will reduce the number of formula products and gradually start to eat regular food. From week 23, you will return to eating only regular food. You will have weekly or fortnightly consultations with the dietitian for 15 - 30 minutes over the phone Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 2 of 7 Intervention Your diabetes can go into remission. 1 in 2 people go into remission on this programme The more weight you lose, the higher the chances that your diabetes will go into remission. This is a big change in the way you eat , and will need commitment on your part and support from the people around you. Most people do not experience side effects but some get mild side effects, such as headache, dizziness, or constipation. The dietitian will help you maintain motivation and manage side effects if needed. Usual care Your d iabetes c are will carry on as normal. Y ou will continue to benefit from the care your GP provides. You will get up to £80 as a thank you voucher for taking part. How will my data be kept? stric tly confidentially and securely in line with the UK General Data Protection Regulations ( UK GDPR) What to do if there are problems? C ontact Elena Tsompanaki on ariadne@phc.ox.ac.uk or at 0 1865289669 What will happen if I don't want to carry on with the study? You are free to leave the study at any point This won’t affect you in any way This won’t affect you in any way What will happen to the results of the study ? The results will be published but you will not be identified in any publication This won’t affect you in any way Risk and benefits Who funded and approved the study? Funded by the Novo Nordisk UK Research Foundation. Approved by the Unive rsity of Oxford Ce n tral University R esearch Ethics Committee (Ref: R82152RE002 ) Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 3 of 7 3. Week 4 ( 20 - 25 minutes ) You will fill in some of the wellbeing questionnaires online 4. Week 12 (30 - 4 0 minutes ) You will fill in all the wellbeing questionnaires, measure your weight at home, report any potential side - effects and your current medication 5. Week 16 ( 20 - 25 minutes ) You will fill in some of the wellbeing questionnaires online 6. Week 24 (30 - 40 minutes ) You will fill in all the wellbeing questionnaires, measure your weight at home, report any potential side - effec ts and your current medication Optional audio - recorded telephone interview to tell us more about your experience 1. Checking you are eligible to take part (30 - 40 minutes ) After your read this information, we will ask you to provide consent and complete questionnaires to determine i f the study is right for you. These should take about 30 minutes. We may send you weighting scales and ask you to confirm your medical history with your GP. The study flow in a nutshell... 2. Randomisation If you are eligible, a computer will decide at random whether you will be in the "intervention" group or the "control" group. You r chances to be in either are 50 - 50 Control Group You carry on as normal You will continue to receive your care as usual. Intervention You will r eceive the products by post You will start the weight loss programme Appointments over the phone with the study dietitian C onsultations over the phone we ekly or fortnightly for 24 weeks. Self - monitoring blood sugars/ blood pressure at home We will give you the monitors if you don't have them 7. Week 52 (30 - 40 minutes ) You will fill in all the wellbeing questionnaires, your weight, any serious problems (serious/severe adverse events), current medication Optional audio - recorded telephone interview to tell us about your experience Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 4 of 7 ARIADNE study – Full details We would like to invite you to take part in our study on low - calorie diet for diabetes treatment and wellbeing. Before you decide, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information, and discuss it with others if you wish. If there is anything that is not clear or if you wo uld like more information, please feel free to contact us: Elena Tsompanaki – Study dietitian Tel: 0 1865289669 E - mail: ariadne@phc.ox.ac.uk What is the purpose of the study? We want to test how a weight loss programme affect someone’s wellbeing. This programme, called total diet replacement, has shown to be very effective in helping people with type 2 diabetes reduce their weight and diabetes medication. It is slowly becoming available across England through the NHS. However, there are still aspects of how it affects wellbeing that are not clear Who is this study for ? We are looking for people who have been diagnosed with type 2 diabetes within the last 6 years. Do I have to take part? No. Taking part is entirely up to you. You are free to leave the study at any point if you change your mind. The decision to do so will not affect you in any way What will happen to me if I decide to take part? • In the beginning, you will go through the screening process where you will answer questions on your health status, medication and complete questionnaires t o determine if this study is right for you. If you are not entirely sure about the answers to some questions, you can speak to the research team We may ask you to confirm your medical history with your GP • I f you are not eligible at any stage, we will delete any identifiable data you inserted up u ntil that point and thank you for your time. • If you are eligible and happy to participate, a computer will place you in either the “control” group or the “intervention” group. You will have 50 - 50 chance to be in the intervention and 50 - 50 chance to be in t he control. • You will be asked to repeat some of the questionnaires online at 1, 3, 4, 6, and 12 months (in total, 5 follow - ups) You will need to do these online within the timeframe given. Please see the diagram above (“The study in a nutshell..”) for det ails. Depending on the follow - up, these can last from 15 to 40 minutes. These follow - ups happen alongside the intervention (total diet replacement or low calorie weight loss programme for diabetes treatment), for the people randomly assigned to the intervention arm. • The whole study lasts for a year and will be done completely remotely. You will need internet access to complete the follow - ups online and a telephone to speak with the study team as needed . If you are in the intervention arm, you can choose to have the sessions with the dietitian either via telephone or video call. What will happen if I am in the intervention group ? Below is an example of how the programme might work, but t he exact plan will depend on your personal circumstanc es and you will work it out it with the dietitian Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 5 of 7 Phase 1 Weeks 1 - 1 2 You will eat only four formula products per day , such as soups , shakes , and bars These formula products will provide you with about 880 calories a day in total and will include all the vitamins and minerals that are essential for good health, but only far fewer calories than most people usually eat. We will provide you with these products. You will have sessions with the dietitian every week or other week and these will last between 20 - 45 minutes, depending on the stage. The dietitian will support you in gett ing adjusted to the programme. You will measure your blood glucose and your blood pressure (if needed) using monitors we will provide you with, and measure your weight regularly at home. The study doctor will make changes to your diabetes and blood pressure medication , usually by asking you to reduce/stop some or all of the medication on your recurrent prescription You won’t have to go to your GP for any study procedures or changes to medication Phase 2 Weeks 1 3 - 22 You will have 3 products a day plus a meal of regular food. You will slowly reduce that to 2 products a day and two meals and then to 1 product a day and regular meals. You will have sessions with the dietitian every week or other week and these will last between 15 - 45 minutes, depending on the stage. The dietitian will support you in moving to eating regular food and help you design an eating plan that is easy to follow and fits your routine. The study doctor will make changes to your diabetes and blood pressure medication. Phase 3 Weeks 2 1 - 24 In the last two weeks, you will return to eating only regular food. You will have sessions with the dietitian every week or other week and these will last between 15 - 45 minutes, depending on the stage. The dietitian will support you in making long - term changes, so that you can stick to your new eating plan and keep the weight off. We will audio - record the sessions with the dietitian, with your consent. This is to analyse the transcripts for themes on people’s experiences, well - being and opinions about the programme. What will happen if I am in the control group? In the control group, you will continue to benefit from your usual care in your GP practice. If you choose to start losing weight either privately, on the NHS , or on your own, you are free to do so , but we will ask you to let us know. We might ask some peop le in the control group to have an interview to share their experiences. This is to understand people’s experiences and well - being. What should I consider? If you agree to take part in the study , we expect you to: follow the programme to the best of your ability respond to the study calls monitor your blood sugar and blood pressure as advised measure your weight and complete all the questionnaires online We also expect you not to: be planning to get pregnant, be pregnant, or breastfeeding (females only). be taking part in other weight loss programmes at the beginning of the trial. be taking part in other studies Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 6 of 7 Are there any possible disadvantages or risks from taking part? There are minimal risks from taking part if you are in the control group. Some people might find some questions in the well - being questionnaires triggering or upsetting. Following an intensive weight loss programme can be demanding and needs commitment fr om you and support from the people around you. Your dedicated dietitian will support you to keep you motivated. The dietitian will also monitor you frequently and carefully, and consult with a specialist study doctor and GP so that you can stop the program me if that is in your best interests . This means that the likelihood of you suffering an adverse event is low In the intervention group, we will advise you to stop all or nearly all medication you may be taking for high blood pressure or diabetes. Becaus e t he diet reduces your blood sugar and blood pressure, we advise you to reduce or stop your medication to make sure that your blood sugar or your blood pressure do not drop too low. C hanging your medication might also raise your blood sugar or your blood pressure at some point . We will therefore ask you to check this regularly and report the readings to the study dietitian Based on your readings, we may also advise you to re - start some of the medications at some point. As t his intervention has been tested before in people with diabetes, there is extensive guidance on how to change medication and/or doses to support people following the programme. Most people do not experience side effects due to the intervention . About one i n five people will experience at least one side effect due to the programme. A few people develop constipation , but we will be providing you with fibre supplements to avoid this, if needed Less common side effects include fatigue, headache, dizziness, dry mouth, abdominal pain, bad breath, diarrhoea, hair loss, dry skin, mood changes, and feeling cold. Most of these side effects do not pose a risk to your health, are mild, and should go awa y as you get used to the diet . We will check in each study visit if you experience any of them. Between study calls , you can let us know about them using the contact details at the front of this document All finger prick tests have a small risk of bruisin g and pain but are routinely done by people with diabetes who need to measure their blood sugars more closely and we will provide you with guidance on how best to do them Females only: It is not advisable to become pregnant whilst losing weight, therefore we advise you to use an effective method of contraception for the duration of the programme . If you need more information on effective contracepti ve methods , please consul t your GP. What are the possible benefits of taking part? Everyone who takes part in this study will be helping us know better how best to help people with type 2 diabetes. Knowing this is one of the main reasons people want to take part in studies More specifically, t he results of this study will help us understand how this programme affects someone’s wellbeing. This information can help us shape the treatment of future patients with type 2 diabetes. Most people who start the programme lose weight, but how much weight you will lose will depend on how closely you will follow the advice you receive. The weight loss may help you to keep being off your diabetes medication The weight loss can also reduce your risk of heart disease. Will my General Practitioner be informed of my participation? Yes. We will send 3 letters in total to your GP: - At the start of the study, to let them know what the study is about and which arm (intervention or control) you have been assigned to - At 6 months, to update t hem of your progress - At 12 months, to update them of your progress and also of the end of the study Will my taking part in the study be kept confidential? Yes. Any information that is collected about you during the course of the research will be kept s trictly confidential. We will use code numbers to avoid identification of participants with their names. All data will be stored securely on password - protected servers and only the research team will be able to access the information. We will store the pseudonymised research data (e.g. questionnaire data, consultation Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 7 of 7 files) securely at the University of Oxford indefinitely after the end of the study . Responsible members of the University of Oxford may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations. Will I be reimbursed for taking part? Control group participants : We will compensate you with up to £ 80 in total. This will be £ 10 in vouchers each time you complete a follo w - up assessment and £15 in vouchers if you a re offered an i nterview , as a thank you for your time. We will also offer you a pre - recorded webinar with the study dietitian in the end of the study, full of dietary tips on how to manage your diabetes and furth er resources. Intervention group participants : You will get free food products and dietetic consultations What will happen to the samples I give? If you are on the intervention group, y our blood sample will be sent for analysis to a n approved third - party provider . A fter the analysis , they will destroy the sample What will happen to my data? You will provide data for the study using REDCap, a secure online platform. We will keep all consent forms for 3 years after publication . We will keep identifiable information (e.g contact details) until the end of the study at the University of Oxford , so that we can inform you about the study results. If you opt to allow us to contact you for future studies, we will keep your contact details for 7 yea rs after the end of the study. We will keep a copy of your consent form with this database, as your consent is our legal basis for re - contacting you under UK data protection law W e will ask you to upload a picture of your prescription or medication online , to ensure we have the right information on your medication. We will delete these as soon as we transfer the information into the study platform. T he dietetic support will be provided by the study dietitian and the de - identified records from the sessions will be kept securely at the University of Oxford indefinitely, as they are usually kept if you go to hospital or your GP. The dietetic sessions and/or telephone interviews will be audio recorded with your consent. We will transcribe s ome parts of these , u sing an approved third - party professional transcription company. The selection will be to analyse different changes in well - being, as reflected in questionnaires. T he copy of the recording held by the company will be deleted as soon as transcribed . The cop y of the recording hel d by the U niversity will be deleted at the end of the study We would like your permission to use direct quotations taken from interviews or sessions but without identifying you in any research outputs. We will keep de - identified research data indefinitely after the end of the study , inc l uding demographic, health and medical data , questionnaire responses, and de - identified tran s cripts De - identified data obtained as part of this study may be used in future research, here or abroad, and may be shared with commercial organisations. Finally, data collected during the study may be looked at by individuals from the University of Oxford where it is relevant to you taking part in this research , for auditing or monitoring purposes. Data protection The University of Oxford is the data controller with respect to your personal data and, as such, will determine how your personal data is used in the study. The University will process your personal data for the purpose of the research outlined above. Research is a task that we perform in the public interest. Further information about your rights with respect to your personal data is available at https://compliance.web.ox.ac.uk/in dividual - rights You can find out more about how we use your information by contacting ariadne@phc.ox.ac.uk We will order the products for the programme in the intervention arm through Nestle Health Science, who will receive your name and address to send them to your house. We have signed a contract with the company to ensure they manage this minimal data responsibly and delete them when they finish with their delivery. The company will compl y with UK GDPR and the Data Protection Act 2018 Participant Information Sheet Version/Date: 1. 1 , 31/01/2023 ARIADNE: Low - calorie diet for diabetes remission and well - being CUREC 3 Participant Information Sheet | Page 8 of 7 What will happen if I don't want to carry on with the study? You are free to leave the study at any time without giving a reason . We will give you the opportunity to tell us the reason for leaving This will not affect you in any way. You can opt to stop the weight loss programme but continue with the follow - ups If you withdraw from the study and further communication , we will only use the data collected up to your withdrawal What will happen to the results of this study? The results of this study will be published in scientific journal s and presented at academic conferences. We will send you a summary of the results. We will also share the results with organisations helping people living with typ e 2 diabetes. Anonymous data will be part of the presentations and publications. You will not be identifiable in any presentation or publication. A copy of the thesis will be deposited both in print and online in the Oxford University Research Archive where it will be publicly available to facilitate its use in future research What if we find something unexpected? F ill ing in questionnaires , measuring your weight, and having a blood test are done for research purposes and not for diagnostic purposes Therefore, none of our research procedures are substitute for a doctor’s appointment. If there is any concern, we will inform your GP and advise you to see them. Who do I contact i f I have a concern about the research or I wish to complain? If a participant in research is ever considered to have suffered harm through their participation, the University has arrangements in place to provide for compensation. If you have a concern about any aspect of this study, please contact Elena Tsompanaki, ariadne @phc.ox.ac.uk , 0 1865289669 or Professor P aul Aveyard, paul.aveyard@phc.ox.ac.uk , +44 (0)1865 617 860 , and we will do ou r best to answer your query. W e will acknowledge your concern within 10 working days and give you an indication of how it will b e dealt with. If you remain unhappy or wish to make a formal complaint, please contact the Chair of the Medical Sciences Interdivisional Research Ethics Committee (MS IDREC) at the University of Oxford who will seek to resolve the matter as soon as possibl e: Email: ethics@medsci.ox.ac.uk; Address: Research Services, University of Oxford, Boundary Brook House, Churchill Drive, Headington, Oxford OX3 7GB. How have patients and the public been involved in this study? We discussed this research with people with type 2 diabetes . They helped make sure this study will be done well. They thought this study was trying to answer an important question . In designing this study, we have taken into account their opinions on the study assessments and weight loss progra mme Who is organising and funding the study? The study is organised by the Nuffield Department of Primary Care Health Sciences at the University of Oxford. The study is funded by the charity Novo Nordisk UK Research Foundation . No personal information about you will be shared with the Novo Nordisk UK Research Foundation The Novo Nordisk UK Research Foundation will be acknowledged in the publications but will have no role in the design, conduct, analysis, interpretation , writin g, and publication of the results. The products for the programme are bought from the company Nestle Health S cience, who will provide them at a discounted price to the research team. The HbA1c home kit tests will be donated to the research team by the co mpany Medichecks, which will also do the analysis in their laboratory. Who has reviewed the study? All research in the University is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed by a subcommittee of the University of Oxford Central University Research Ethics Committee (Ref: R82152/RE001 ) Further information and contact details: Please contact Elen a Tsompanaki on 01865289669 or at ariadne@phc.ox.ac.uk