BUMP 2.0 Study Participant Information Sheet , version 1 1 , 2 9 th January 202 5 Central University Research Ethics Committee Approval Reference: R95714/RE001 1 Principal Investigator: Dr Moscho Michalopoulou Tel ephone : 01865 2 89505 E - mail: bumpstudy@phc.ox.ac.uk Body weight awareness and support for mums during pregnancy (BUMP 2.0 ) Participant Information Sheet Central University Research Ethics Committee Approval Reference: R95714/RE001 We would like to invite you to take part in this research study. Before you decide, it is important that you understand why the research is being done and what it will involve for you. Please take time to read this information and discuss it with others if you wish. If anything is not clear, or if you would like more information, please ask us. What is the purpose of the study? We have developed a mobile application (app) designed to support women to manage their weight gain during pregnancy. The aim of th is study is to test if women want to use this app, and how often they do so from early or mid - pregnancy until delivery. We will ask women who take part about their experiences. If the results are promising, we will run a bigger study to test whether the ap p can help women to effectively manage their weight gain and improve h ealth outcomes during pregnancy Why have I been invited? You have responded to an advert on the internet. We are looking for 120 women, aged 18 years or older, who are pregnant before 20 weeks, with access to the internet with a smartphone and/or tablet, as well as access to weighing scales, who are able to communicate in English, and who are interested in managing their weight gain during pregnanc y with the help of a mobile app Do I h ave to take part? No, you don’t have to take part. Taking part is entirely voluntary. If you decide not to take part, this will not affect the care you receive during pregnancy and delivery. If you do decide to take part, but then change your mind, you can withdraw at any time without giving a reason, by advising the researchers on this decision. This will not affect the care that you receive What would taking part involve? Taking part in th is study will all happen online First, we will check if you are eligible to take part in this study by asking you over the phone a few questions (1 - 2 minutes). If you are eligible, we will ask you to provide us with your consent over the phone to show that you understand what we are asking of you during this study, and ask your name and contact details (<5 minutes). We will send a copy of the consent form to you in the post. We will then ask you to complete an online questionnaire with some information about yourself, e.g. age, education, ethnicity, employment status, and your pregnancy ( e.g. pregnan cy stage , estimated due date , how your pregnancy care is being recorded and monitored ) . We will also ask you to report BUMP 2.0 Study Participant Information Sheet , version 1. 1 , 2 9 th January 202 5 Central University Research Ethics Committee Approval Reference: R95714/RE001 2 your height, and to weigh yourself on your own scales and report your weight on the online questionnaire. If possible, we would like you to upload or email a photograph of your weight displayed on the scales for verification purposes. This first assessment will take no more than 10 minutes to complete Following the first assessment, you will b e randomly allocated to one of the two study groups. Two - thirds of participants will be allocated to the test group. If you are in this group, you will receive access to a mobile app called BUMP, designed to help you manage your weight gain during pregnanc y. The rest of the participants will be allocated to the control group which will not receive access to the mobile app. The control group is very important for this research as it helps us test if the use of our app is more beneficial than the usual things women may do to manage their weight during pregnancy. We cannot predict to which group you will be allocated, as this is entirely down to chance and decided by a computer programme. You cannot choose which group you are in, and you will not be able to cha nge group once you have been allocated, as it would not be a fair test of the benefits of the app if we took your preference into account. If you are allocated to the test group, you will be asked to download the BUMP app from the Apple or Android store on your mobile or tablet device, and access this using a unique passcode. You will also receive instructions on how to use the app during pregnancy to support you to manage your weight gain. If you are allocated to the control group, you will not need to do anything further until follow - up. Both groups will continue to receive usual antenatal care and support given to women who are pregnant. Towards the end stages of pregnancy (between 34 weeks and before delivery) we will ask both groups to complete the follow - up assessment. We will send you another online questionnaire We will first ask you if anything has changed with the progress of your pregnancy that we should know about. If everything is well, you will need to report your current stage of pregnancy We will also ask you again to weigh yourself on your own scales and report your weight on the online questionnaire, and upload or email a photograph of your weight if you can. This follow - up assessment will take no more than 5 minutes to complete. If you are in the BUMP app test group, we may ask if you would be willing to have an in - depth interview on the phone with a member of the study team about your experiences of the app - based programme. This is entirely optional and we will ask your permission to a udio - record the interview. We will provide you with more details closer to the time. The study will end when you give birth What should I consider? To be able to take part in this study, you need to be able to access the internet on a smartphone and/or tablet, as well as have access to weighing scales. You will not be able to take part if you do not consent and complete the first study assessment before you reach 20 weeks of pregnancy. If you are eligible and decide to take part, you can continue to take your regular prescribed or over - the - counter medications during the study What are the possible benefits of taking part? If you are randomised to the test group, you will have access to the BUMP app to support you to manage your weight gain during pregnancy. Regardless of whether this helps you personally, taking BUMP 2.0 Study Participant Information Sheet , version 1. 1 , 2 9 th January 202 5 Central University Research Ethics Committee Approval Reference: R95714/RE001 3 part in this research will help us learn more about weight management during pregnancy, and may help to plan a bigger study which may help in the future other women who are pregnant, to control their weight gain, and to possibly improve health outcomes during pregnancy Are there any possible disadvantages or risks from taking part? There are no kno wn risks from taking part. Some people worry that managing weight during pregnancy may cause undue concern about weight and food. However, research suggests that there are no negative consequences from weighing or providing adv ice on weight during pregnanc y. If you are concerned about your weight or any aspect of your pregnancy, you can speak to your clinical team. Will I be reimbursed for taking part? When you complete the follow - up assessment at around 36 weeks of pregnancy, you will be entered into a dr aw to win one of eigh t baby bundles worth at least £10 0 What information will be collected and why is the collection of this information relevant for achieving the research objectives? We will collect the following information from you in order to undertake this study: self - reported anthropometric data (e.g. weight, height), demographic data (e.g. age, ed ucation , ethnicity, employment status), information on your pr egnancy (e.g. stage of pregnancy , estimated due date , how your pregnancy care is bein g recorded and monitored ), and your personal contact details (e.g. e mail, mobile phone number, postcode ). All data will be collected through the study - specific website and app, owned and managed by the University of Oxford, that have been developed by us i n collaboration with a team of app developers. These developers have been checked thoroughly by the University to make sure they follow all relevant data protection guidelines. Any data that we collect about you during this study will be kept strictly conf idential. You will be assigned a unique study code to avoid identification with your name. The study’s de - identified database where all data are recorded, will be password - protected and kept on a secure University server, accessible only to the study team. After the study has finished, the de - identified research data will be stored on a secure University server for 3 years after the end of the study, and will then be deleted. We will keep your contact details separately from the research data that we have collected for a year after the end of the study, in order to prepare and send you a summary of the study results. This list will be encrypted and kept in a password - protected folder with limited access on a strictly need - to - know basis, on a secure University server. The electronic copy of your consent will be stored on a password - protected folder on a secure Universit y server, and a physical copy will be held securely at the University of Oxford, for 3 years after the end of the study, and will then be deleted and destroyed respectively. Audio - recordings from interviews will be encrypted and kept securely in a password - protected folder on the secure University server. After transcription they will be deleted, and the transcribed audio - recordings will be de - identified and kept securely on the University server for 3 years after the study has ended. Relevant 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. At all times, personal data collected from you will be held in compliance with the requirem ents of the G eneral D ata P rotection R egulation and the Data Protection A ct 2018. 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 BUMP 2.0 Study Participant Information Sheet , version 1. 1 , 2 9 th January 202 5 Central University Research Ethics Committee Approval Reference: R95714/RE001 4 study. The University will process your personal data for the purpose of the research outlined above. Research is a task that is performed in the public interest. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual - rights What will happen if I don’t want to carry on with the study? If you decide that you want to take part, but change your mind later, you can withdraw from the study a t any point and without giving us a reason. If you decide to withdraw we will delete your account on the study app, but we will use in our analyses any research data which we have collected from you up to the point at which you decide to withdraw, unless y ou explicitly request us to delete them. What will happen to the results of this study? The results of this study will help us design future studies with the aim of helping women who are pregnant manage their weight gain during pregnancy. The study results will be published in scientific journals and may be presented at scientific conferences. All results will be presented or published in a form that does not identify you. We will send you a summary of the stu dy results once the study has finished and data has been analysed. How have patients and the public been involved in this research? We have discussed the app and this research with women who have been pregnant. They helped to shape the ideas for this rese arch and to refine the app Who is organising and funding the research ? This study has been funded by the National Inst itute for Health Research as part of the Oxford and Thames Valley Appli ed Research Collaboration. Who has reviewed this research? This r esearch has been reviewed by, and received ethics clearance through, a subcommittee of the University of Oxford Central Univer sity Research Ethics Committee (Reference number: R95714/RE001 ). Who do I contact if I have concern or wish to complain? If you have a concern about any aspect of this research, please contact the research team at bumpstudy@phc.ox.ac.uk or 01865 289505. The research team will acknowledge your concern within 10 working days and gi ve you an indication of how they intend to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the University of Oxford Research Governance, Ethics & Assurance (RGEA) team at rgea.complaints@admin.ox.ac.uk or on 01865 616480 Further information and contact d etails If you would like to discuss the research with someone beforehand (or if you have questions afterwards), please contact Dr Moscho Michalopoulou, Nuffield Dep artment of Primary Care Health Sciences, Radcliffe Primary Care Building, Woodstock Road, Oxford, OX2 6GG, at bumpstudy@phc.ox.ac.uk or 01865 289505. Thank you for considering taking part in this study