CompletedInterventional

New structured weight management pathway for diabetes remission

Losing weight can help many people with type 2 diabetes put their condition into remission, meaning their blood sugar returns to normal without diabetes medicines. This study, called NewDAWN, is run by the University of Oxford to find the best way to support people in reaching remission. Participants are placed into one of two groups. The first group follows the standard NHS Pathway to Remission, which involves using meal replacement shakes and soups for up to 12 weeks before slowly returning to ordinary food. The second group uses the new NewDAWN service. Here, a personal health coach helps participants choose an approved weight loss programme. If that programme does not suit them, they can switch and try up to four different options. The goal is to see if giving people more choice and regular coaching leads to better long-term weight loss and health.

At a glance

Status

Completed

Sponsor

University of Oxford

Enrolment target

1,788

Start

06 Nov 2023

Estimated completion

07 Apr 2025

Type 2 diabetes

What is this study about?

Type 2 diabetes is a common condition that causes the level of sugar in the blood to become too high. Strong evidence shows that for people carrying extra weight, losing a significant amount of weight can put type 2 diabetes into remission. Remission means that your blood sugar levels stay in a healthy range without needing to take diabetes medication. While this is not a permanent cure, it can greatly improve your long-term health.

The NHS already offers a programme called the Pathway to Remission, which uses low-calorie meal replacements such as soups and shakes to kick-start weight loss. However, this rigid approach does not work for everyone. Some people find it hard to stick to, or would prefer a different kind of diet.

This trial is testing whether an adaptable approach works better. Instead of creating brand new diets, researchers are testing a support system called NewDAWN. Participants in NewDAWN work with a trained coach who helps them pick an NHS-approved or local weight loss plan that fits their life. If a participant finds that the first plan is not working, the coach helps them switch to another one, with up to four different programmes available to try.

By comparing this flexible coaching approach to the standard NHS programme, researchers hope to learn whether giving patients more choice helps more people achieve diabetes remission and maintain a healthy weight.

Key takeaways

The NewDAWN trial explores whether flexible diet choices help people reverse their type 2 diabetes.
It is open to adults aged 18 to 70 diagnosed with type 2 diabetes in the last year.
Participants either follow the standard NHS low-calorie shake diet or get a coach who helps them try up to four different weight loss plans.
Doctors will carefully monitor your health and adjust your medications to keep you safe as you lose weight.
All diets and services used in the trial are already approved and tested by the NHS.

Who may be eligible?

You may be able to join this study if you are between 18 and 70 years old and were diagnosed with type 2 diabetes within the past 12 months. You must also have a body mass index (BMI) of 27 or higher, be registered with a GP surgery that is taking part in the study, and be happy to be placed into either of the two study groups.

You will not be able to take part if your diabetes is already in remission, if you are currently using insulin injections, or if you have already taken part in the NHS Pathway to Remission programme. People who have recently started certain diabetes medications (GLP-1 agonists or SGLT2 inhibitors) within the last three months are also excluded.

Additionally, this study is not suitable for people who are pregnant, breastfeeding, or living with an eating disorder. For safety reasons, people with very high blood sugar levels (an HbA1c of 87 mmol/mol or higher), recent heart attacks or strokes, severe eye complications from diabetes, or other serious health conditions cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I was diagnosed with type 2 diabetes within the last 12 months.
I am between 18 and 70 years old.
My BMI is 27 or higher (carrying extra weight).
I do not use insulin injections.
I am not pregnant or planning a pregnancy.
My GP practice is participating in the NewDAWN study.

Answer every question to see your result.

What does participation involve?

Taking part in the study begins with an initial visit at your GP practice to check your health, measure your height and weight, and confirm that the study is safe for you. You will then be randomly assigned by a computer to one of two groups.

If you are in the standard NHS care group, your GP practice will refer you to the NHS Pathway to Remission. You will replace your usual meals with low-calorie soups and shakes for 8 to 12 weeks, supported by weekly or fortnightly appointments. After this, you will slowly reintroduce healthy solid food with continued support.

If you are in the NewDAWN group, you will be paired with a health coach. You will talk to your coach by phone to choose a weight loss plan that suits you best. Your coach will ring you at two weeks, and then every four weeks, to check how you are doing. If your chosen plan is not working for you, your coach will help you switch to a different approved programme, with up to four options to try.

Throughout the study, your GP will monitor your health and safely adjust any blood pressure or diabetes medicines as you lose weight. You will also attend follow-up visits to track your weight, blood sugar levels, and general well-being over the course of the study.

Potential risks and benefits

The main benefit of taking part is the opportunity to lose weight with professional support, which may help you put your type 2 diabetes into remission and reduce your need for medication. All the diets offered are already approved and used in the NHS. The main risk relates to medication changes. Losing weight quickly can cause blood pressure or blood sugar to drop too low if your medicines are not adjusted in time. Conversely, stopping medicines without losing enough weight could cause blood sugar to rise. To keep you safe, doctors will closely monitor your health and follow clear national NHS safety guidelines. Taking part is completely voluntary, and you are free to leave the study at any time without it affecting your normal medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NIHR CRN: Thames Valley and South Midlands
City only
Oxford, England

Common questions

What does diabetes remission mean?

Remission means your blood sugar levels have returned to a safe, healthy range without the need to take diabetes medication. It is not guaranteed to last forever, but it can protect your health.

Can I choose which group I am in?

No. A computer randomly assigns you to either the standard NHS programme or the NewDAWN coaching group to ensure the study results are fair and reliable.

Do I have to pay for the meal replacements or coaching?

No. All study-related programmes, meal replacements, and coaching sessions are provided free of charge through the NHS and the research team.

What happens if I cannot stick to my diet plan?

If you are in the NewDAWN group, your coach will help you change to another approved programme. If you are in the standard group, your team will offer support to help you manage challenges.

Can I leave the study if I change my mind?

Yes. You can leave the study at any point. Your decision will not affect the quality of your regular NHS care in any way.

How to find out more

Nicola Guess

nicola.guess@phc.ox.ac.uk +44 (0)1865617826 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.