Participant Information Sheet (Study 2)
Short study title: The MyBarrriers Study.
Full study title: Development of a scale to measure cognitive behavioural phenotypes associated with barriers to weight management
Principle Investigator: Dr Paul Sacher
Co-investigators: Dr Luke Pratsides, Dr Jennifer Liu, Asif Laldin, and Dr Emmie Fulton
You are being invited to take part in a research study. Before you decide whether you would like to take part, it is important to understand why the research is being carried out and what it will involve.
Please take the time to read the following information carefully and discuss it with others if you wish. Ask us if there is anything that is not clear or if you would like more information.
Thank you for reading this.
What is the purpose of the study?
The aim of the study is to create a new questionnaire (scale) for Numan patients, that measures some of the common and individual barriers you may experience to successful weight loss and management long-term.
The responses to the scale will enable us to assign new Numan patients to one or more Cognitive Behavioural Phenotypes, or ‘Barrier Types’. Each Barrier type will consist of grouped patterns of common thoughts and beliefs; social, environmental, practical and emotional barriers to successful weight management.
By assigning patients to Barrier Types, we can improve the weight loss programmes that we offer by providing support that is more tailored, appropriate and specific to the needs of the individual. Patients will be supported to better understand why they have struggled with managing their weight to date, with clear and practical guidance on how they can overcome these barriers, should they wish.
In this study, we will create a draft questionnaire with lots of possible questions that we can test with research participants. This will help us decide which questions to keep and which are not useful or needed. The questions have been designed by experts from weight management, psychology, nutrition and health coaching, using a scientific framework. By the end of the study, we hope to have a final scale that is scientifically tested and accurately measures what it’s designed to.
Why have I been invited?
You have been invited because you have recently joined the Numan Weight Management Programme and are due to commence taking either Wegovy (Semaglutide) or Mounjaro (Tirzepatide) for weight loss. We are inviting around 100 people aged 18 to 65 to take part in this study.
We are inviting participants via the Numan app before they start on their medication and health coaching.
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be offered the chance to ask any questions that you may have, and then be asked to sign a consent form. This is just to show that you understand what the study is for and agree to take part. If you decide to take part you are still free to withdraw at any time and without giving a reason.
What will happen to me if I take part?
Taking part in the study takes place entirely online. You will be asked to complete 2 sets of questionnaires, at least 7 days apart. As questionnaires need to be completed before you start your medication, your medication will be sent after completion of the 2nd questionnaire.
You will receive a link to first complete a short survey with a little information about yourself (known as a ‘Demographic Survey’) e.g. name, age, gender, current weight, ethnicity and so on. This will be saved securely and kept separate from your answers to the questionnaires to follow so that those answers remain anonymous.
You will then be prompted to complete both a new version of the questionnaire we are developing (20 questions) and also 2 other short questionnaires that are currently used worldwide in research. These will look at your confidence around weight loss; and also thoughts about your weight loss journey, the impact of friends and family on your weight loss strategies, and knowledge and understanding about how to lose weight and form new lasting habits. The reason we include these is so we can test statistically if our new scale is measuring something unique but also that answers are in line with what we would expect from similar scales. The other 2 scales together are 28 questions long. We will then ask you to complete the same 3 questionnaires 7 days later. We do this so we can see how people’s responses change, if at all, over time.
We expect the questionnaires will take no longer than 10 minutes to complete at each time point. You will receive a £50 discount on your next two medication orders for your time (£100 in total).
Why are you asking for the first part of my postcode and my occupation?
We realise that these questions might seem intrusive or sensitive for some participants. The reason we are collecting this information is that we want to create a tool that is relevant and useful for as many patients as possible, ensuring it is suitable for Numan patients from a range of educational and financial backgrounds. The first 4 digits of your postcode provides us with an indication of the broad area you live in but does not provide any identifiable information – e.g. your address is not identifiable from this information.
How will you store my data?
Your data will be processed in accordance with the General Data Protection Regulation 2016 (GDPR). All data is stored on a password protected computer, on secure Numan servers, and only accessed by members of the research team. The information about you (‘Demographic Survey’) will be kept separately from the questionnaire data so that your answers remain anonymous. An ID number will be used to match your data. Data will be stored securely for up to 5 years, after which point it will be deleted.
What are the possible disadvantages and risks of taking part?
There are no known risks to taking part. The questions have been designed to be sensitive and appropriate, however you do not have to answer anything you do not wish to. If there is anything that concerns you, or you wish to seek support regarding, you are invited to contact a member of the research team – Dr Luke Pratsides - [email protected]. Should discussion of topics relating to barriers to weight loss cause emotional distress, you will be offered access to support via your Numan health coach.
At this stage in the scale development we will not be able to provide participants with immediate tailored information and feedback about their personal barriers to weight loss that will eventually be made available to patients on completing the scale. However, by taking part, you are helping make this available to patients shortly, and this feature will be offered to all study participants (yourself) as soon as it is available.
What if something goes wrong?
If you have a concern or complaint at any stage during the study you are invited to contact the research team lead: Dr Luke Pratsides - [email protected]. If you are still not satisfied with the response, you may contact the Independent Sector Complaints Adjudication Service (ISCAS) - [email protected].
What will happen to the results of the research study?
The results of the analysis of the grouped data from all participants who took part in the research will be used to develop a new tool to help support future Numan patients in their weight loss journey. The findings will also be published in a peer reviewed scientific journal approximately 3-6 months after the study ends. Participants will be sent a summary for the grouped findings to their email address. All data that is made publicly available will be anonymous. You will not be identifiable in any report/publication.
Who is organising and funding the research?
Numan (part of Vir Health Ltd) is both funding and conducting the research. Numan is a digital health service providing online consultations on a specified range of health conditions including men’s health, and obesity management. It operates through the following website: www.numan.com. Numan is CQC registered with a good overall rating.
Who has reviewed the study?
This study was given favourable opinion by the Independent Research Ethics Committee (IREC). See http://www.irec.org.uk.
Contact for Further Information
You are welcome to contact the medical lead for this study: Dr Luke Pratsides - [email protected] if you have any questions or queries about the study or taking part.