RecruitingNAINTERVENTIONAL

Low EnerGy DiEt iN Adolescents With Obesity and Type 2 Diabetes: The LEGEND Study

The LEGEND study is investigating a special low-energy diet (LED) for teenagers aged 12-17 who have both obesity and type 2 diabetes. The main goals are to find out how many young people are willing to join and stay on the diet, and to estimate how much weight loss is needed to put their diabetes into remission (meaning blood sugar levels return to normal). The study also includes interviews with participants, their parents, and healthcare staff to understand everyone's experiences, including reasons why some might choose not to take part in the diet. This information will help plan future, larger studies.

At a glance

Status

Recruiting

Phase

Sponsor

Nottingham University Hospitals NHS Trust

Enrolment target

Start

30 Jun 2025

Estimated completion

31 Dec 2026

Pediatric Obesity Type 2 Diabetes

What is this study about?

The LEGEND study is looking into whether a special diet called a Low-Energy Diet (LED) can help teenagers (aged 12-17) who have both obesity and type 2 diabetes. Type 2 diabetes is a condition where your body doesn't use sugar properly, leading to high blood sugar levels. Obesity is when you carry too much weight for your height. This study wants to understand if this diet can help these young people lose enough weight to improve or even reverse their diabetes.

The study involves three main parts for those on the diet. First, there's an intensive 12-week period where participants mostly have shakes, soups, or bars that provide a set amount of calories. These are provided for free by the study team. After this, there's a 12-week phase where normal foods are slowly brought back into the diet, with help from a dietitian. Finally, there's a weight maintenance phase to help keep the weight off. The aim is for participants to lose a certain amount of weight and get their blood sugar levels back to a healthy range.

Besides the diet itself, the study also includes interviews. Some young people and their parents who take part in the diet will be interviewed about their experiences. Other young people and their parents who choose *not* to do the diet will also be interviewed to understand why. Lastly, the healthcare professionals involved in the study will be interviewed to hear about their insights. All this information will help researchers make future studies even better and understand how best to support young people with type 2 diabetes and obesity.

Key takeaways

The study helps teenagers with obesity and type 2 diabetes.
It uses a special low-energy diet with support from doctors and dietitians.
The goal is to help young people lose weight and improve their diabetes.
Participants get free meal replacement products during the diet phase.
Interviews will help understand everyone's experiences with the study.
You can choose to leave the study at any time.

Who may be eligible?

This study is specifically looking for teenagers who are between 12 and 17 years old and have been diagnosed with type 2 diabetes. Their blood sugar levels, as measured by an HbA1C test, need to be within a certain range. They also need to have obesity, which is measured by their Body Mass Index (BMI).

To join the main diet part of the study, the young person (and their parent or carer if they are under 16) must agree to take part and be willing to commit to the special diet and all the follow-up appointments. If a young person is 16 or 17, they can give their own permission, but if they are 12 to 15, their parent or carer needs to give permission, and the young person must also agree.

Even if someone doesn't want to do the diet, they might still be able to take part in the interview parts of the study. This would involve chatting with researchers about their thoughts and experiences with type 2 diabetes and obesity, alongside a parent or carer, if they meet the age and health criteria mentioned above.

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.

Are you between 12 and 17 years old?
Do you have a diagnosis of type 2 diabetes?
Do you have obesity (carrying too much weight for your height)?
Are you willing to commit to a special diet plan and regular check-ups?
If you are 12-15, is your parent or guardian willing to give permission and support you?

Answer every question to see your result.

What does participation involve?

If you take part in the diet part of the study, you'll work closely with a dietitian and doctor. The study will last for several months. For the first 12 weeks, you'll mainly use special meal replacement products (like shakes, soups, or bars) that the study provides for free, to keep your energy intake low. After this, over the next 12 weeks, you'll gradually reintroduce regular food with guidance from the dietitian, using special recipes. Finally, there will be a phase focused on maintaining the weight you've lost. You'll have regular visits to the clinic to check your health, blood sugar levels, and weight, and to get support from the study team. Overall, you'll need to be committed to following the diet and attending all scheduled appointments.

Some participants, and their parents or carers, will also be asked to take part in interviews. These interviews are a chance to share your thoughts and experiences about the diet and the study. If you choose not to do the diet, you might still be asked to be interviewed about your reasons for not taking part. The healthcare staff involved in the study will also be interviewed about their experiences.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as significant weight loss and the chance to improve or even reverse your type 2 diabetes, which could greatly improve your long-term health. You'll receive close medical supervision and support from healthcare professionals throughout the process, and the diet products will be provided at no cost. However, a low-energy diet can be challenging and might lead to temporary side effects like tiredness, headaches, or feeling hungry, especially at the beginning. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Nottingham University Hospital NHS Trust
Verified postcode
Nottingham, United Kingdom· Recruiting

Common questions

What is a Low-Energy Diet (LED)?

An LED is a special diet where you get a very small number of calories each day, often by using meal replacement shakes, soups, or bars, to help with quick weight loss.

Will I have to pay for the special diet food?

No, if you take part in the diet phase of the study, the special meal replacement products will be supplied and given to you by the study team for free.

What is 'remission' for type 2 diabetes?

Diabetes remission means that your blood sugar levels return to normal without needing to take diabetes medication, even though you still have the condition.

Can my parents be involved?

Yes, if you are 12-15 years old, your parent or carer will need to give permission for you to join, and they may also be asked to take part in interviews with you.

What if I don't want to do the diet part, but still want to help?

You might still be able to take part in the study by having an interview with researchers, alongside a parent or carer, to share your experiences and reasons for not doing the diet.

How to find out more

Pooja Sachdev, MD

pooja.sachdev@nhs.net 0115 924 9924 Official trial record

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