Main Trial

The Main Trial aims to compare “PROGROUP” with NHS usual care. There will be 780 patients taking part, in approximately 8 sites around the UK. We will measure weight loss 6 months and 12 months after starting the programme. We will also measure whether PROGROUP is cost effective, and other things that patients say are important to them.

What is the aim of this research? 

The PROGROUP trial aims to test if a new programme (called PROGROUP) helps people with severe obesity manage their weight. We are comparing PROGROUP to the normal care given by the NHS (“usual care”).

We have already tested PROGROUP with a small number of people (the feasibility trial). This small study found people liked taking part in the programme. But it did not compare weight loss between PROGROUP and NHS usual care. Now, we are testing PROGROUP with more people in a bigger study – the PROGROUP Trial.

What is the PROGROUP programme?

This program has fifteen sessions over five months with a team member from the weight management clinic (a facilitator). The facilitator could be a nurse, dietitian, or physiotherapist who is trained to lead the programme.

Participants meet in a group of about twelve people with the facilitator. There are also some one-to-one sessions with the facilitator. Participants will learn ways to make lasting changes their eating and exercise habits. There is also advice on diet and nutrition.

Click here to find out more about the PROGROUP programme.

Who is being asked to take part in this research?

We are looking for people who have been referred to the specialist weight management services. Who’s doctor at the weight management clinic thinks are suitable for this study, but it is up to you them to decide whether or not to take part.

What happens if you take part?

We are running this study in many places across the UK. About 780 people will be needed for the study, to be certain of the results. 

Participants will be asked to complete a questionnaire. Then they will be placed in the PROGROUP programme or the NHS usual care programme.  Half of the participants will be in the PROGROUP programme and half will be in the NHS usual care programme.  This is done at random (by chance – like tossing a coin) by a computer. Both groups are equally important to this study.

We will measure patients’ weight at the start, and 6- and 12-months later. At the same time participants will be sent online questionnaires to find out about their mental and physical health, including use of health and social care services. These questionnaires will take around 30 minutes to complete.

Some participants will also be invited to take part in a telephone/Zoom interview with a researcher. This is to find out what they thought about the study. 

How long will patients be involved for?

Study participation lasts for 12 months. 

What are the possible benefits of taking part?

We don’t know yet if the PROGROUP programme is effective. Participants who are put in the PROGROUP programme may find the care they receive useful. All participants will help us learn more about how best to support people who use weight management services in the future.

How will we share the results of this study?

We hope to finish this research by the end of 2026.

Participants will be able to read a summary on the results on the Peninsula Clinical Trials Unit website (www.plymouth.ac.uk/penctu). We will publish the results in a scientific journal. We will also share results at scientific meetings.