Introduction:

Summary of the Study:
• In this research study, we will collect information from you and your medical team. We will only use the information that is needed for the study.
• Only a small number of people will have access to your name or contact details, and only if it is absolutely necessary for the research.
• Everyone involved in the study will keep your information safe, secure, and private. We will follow all data protection and confidentiality rules.
• Some of your data will be saved at the end of the study so we can look at the results and answer future research questions.
• When we share the findings, we will write them in a way that means no one will be able to tell who you are.

We would like to invite you to take part in our research study. Before you decide if this is right for you, it is important that you understand why the research is being done and what taking part will involve. Please take your time to read this information and discuss it with others if you wish. If there is anything that is not clear, or if you would like more details, please ask us.

What is the CORE Study?
The CORE Study is a national research project starting in 2025. It aims to find out if a new app, called PeopleWith, can help us collect important information about:
• Who attends to specialist weight management clinics
• What treatments are offered in these clinics
• How well these treatments work.

If the study, is successful, the app could be adopted by the NHS to help improve care for patients attending these clinics.

What is the purpose of the Study?
In the UK, obesity care is organised into four levels:
• Tier 1: Focuses on prevention through public health programmes, such as encouraging healthy eating and exercise.
• Tier 2: Community-based services, such as Weight Watchers or the Counterweight Programme, are for people with a BMI between 28–35 who don’t have complicated medical issues.
• Tier 3: Specialist clinics offer treatments for people with more complex needs - those with a BMI over 35 (or 30 if they have diabetes) or other medical conditions. These services may offer medication, low-energy liquid diets, and support before and after weight-loss surgery.
• Tier 4: Focuses on bariatric (weight-loss) surgery, usually provided in hospitals.

While there is good data on Tier 1 prevention programmes and who attends Tier 4 services and has weight-loss surgery, we know very little about what happens in Tier 3 clinics. Only 4 out of the 42 Tier 3 NHS clinics currently share information. This makes it hard to understand:
• Who is using these clinics
• How referrals are managed
• What treatments are offered
• How well these treatments are working

This lack of data makes it difficult to ensure fair access to these services and to improve care.

Previous attempts to collect data from these specialist weight management services have failed, often because staff in busy clinics don’t have the time to enter the information themselves. In this study, we are testing a new app called PeopleWith to see if it can help collect important data directly from patients. people attending specialist weight management clinics.

To show it works, we need:
• 50% of Tier 3 weight management services to start using the app, and,
• Have at least 60% of patients at those clinics share their information through it.

This study will help us understand if the app can track who uses these clinics and how effective the treatments are. If the app works, the NHS could use it across all weight management services to gather the data needed to improve services and outcomes for everyone.

Why have I been invited to take part in the Study?
You have been invited to join this study because you attend a specialist Tier 3 weight management clinic in the UK. We are looking for 41,160 volunteers from around 50% of weight management services to take part and allow us to collect information about their experiences and care.

Do I have to take part in this Study?
• The answer is ‘No’: taking part is entirely voluntary.
• If you do decide to take part, but then change your mind at a later date, you can withdraw, without giving a reason;

Answering ‘No’ or withdrawing at a later date will not affect your clinical care in any way.

What will I have to do if I decide to take part in this study?
If you decide to take part and feel all your questions about the study have been answered, the first step will be to download the PeopleWith app. We will provide instructions to help you do this. Before using the app, you will be asked to sign a consent form, which can be done electronically or on paper if you prefer. A copy of the consent form is shown at the end of this information sheet.

After signing the consent form, you will asked to use the app to enter some personal and medical information, as well as answer questions about your general health and quality of life. If you develop new medical problems or start new medications during the study, we would ask you to update these details in the app. Every six months, you will be asked to update the health and quality-of-life questions. You will be asked to continue using the app for as long as you attend the Tier 3 weight management clinic.

You can see a full list of CORE Study data requirements in the patient information sheet.

During your clinic visits, your treatment details will be added to the app’s secure online system by your healthcare team or research staff.

Now, at the beginning of this Study, you will be asked to download an app called "PeopleWith" which is available through your normal App Store. Following the steps below will provide information on how to get started with the PeopleWith App.

For full information, please review the patient information sheet below.

If you wish to continue, please follow the steps below to get started on the PeopleWith App.

Additional Help & Support:

If you require any additional help & support with the PeopleWith App, please contact: support@peoplewith.com. We aim to respond to all requests within 2 working days.