RecruitingNAINTERVENTIONAL

Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial

This important study, called LightBAR, is looking at two ways to help adults with severe obesity lose weight. One way is an intensive programme involving special diets, lifestyle support, and weight-loss medicines. The other way is weight-loss surgery (like gastric bypass). The researchers want to compare how well both treatments work, if they have any side effects, and if they lead to lasting weight loss. Currently, surgery is often the main effective treatment for severe obesity, so understanding if intensive lifestyle changes can be as good is really important. The results will help doctors offer the best care paths for people struggling with their weight.

At a glance

Status

Recruiting

Phase

Sponsor

Carsten Dirksen

Enrolment target

500

Start

08 May 2024

Estimated completion

01 Dec 2048

Obesity

What is this study about?

Imagine you're facing a big health challenge because of your weight, and you're looking for the best way to get healthier. This study, called LightBAR, wants to help find clearer answers for people with severe obesity. Doctors often suggest weight-loss surgery for people in this situation because it's known to be very effective. However, surgery isn't for everyone, and it has its own set of considerations.

This study is comparing weight-loss surgery with another option: a two-year intensive programme that doesn't involve surgery. This programme includes special meal replacements, support to change daily habits, and weight-loss medicines if needed. The goal is to see if this non-surgical approach can be as good as surgery in helping people lose weight and become healthier, while also looking at any potential downsides of each method.

By carefully comparing these two different paths, the researchers hope to gather vital information. This information will help doctors and healthcare providers decide the best treatment plans for people with severe obesity in the future, giving patients more proven options to consider.

Key takeaways

The LightBAR study compares an intensive weight loss program to weight-loss surgery.
It aims to find the best and safest ways to help people with severe obesity.
The intensive program involves special diets, lifestyle support, and sometimes medication.
Participation requires being within a specific age range and eligible for bariatric surgery.
The study lasts for two years, with regular health check-ups.
Your treatment group will be decided by chance, not by choice.

Who may be eligible?

To join this study, you usually need to be invited by a doctor involved in the research. Generally, you would be between 18 and 60 years old. You'd also need to be a candidate for weight-loss surgery according to national health guidelines in the UK or Denmark. This usually means having a high Body Mass Index (BMI) – for example, a BMI of 35-40 with other health issues like type 2 diabetes or high blood pressure, or a BMI over 40 on its own.

It's important that you are otherwise healthy enough for surgery and able to safely have anaesthesia. Before considering surgery, you might also have had, or be willing to receive, intensive support from a specialist obesity service. You must also be willing to give your 'informed consent' – meaning you understand what the study involves and agree to take part.

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 18 and 60 years old?
Have severe obesity and are considered for weight-loss surgery by a doctor?
Are you generally fit enough for an operation?
Have you *not* had weight-loss surgery before?
Are you *not* currently using weight-loss medications (for the last 3 months)?
Do you have any conditions that make strict diets or certain medicines unsafe (like type 1 diabetes, pancreatitis)?
Are there any other conditions that might make surgery risky (like severe digestive issues)?
Are you willing to give your full agreement to participate?

Answer every question to see your result.

What does participation involve?

If you're invited and join the study, you'd be put into one of two groups by chance (like flipping a coin) – either the intensive weight loss programme or the weight-loss surgery group. If you're in the intensive weight loss group, the programme lasts for two years. It starts with a special diet of total meal replacements for 12 weeks, along with support for changing your habits. After that, you'll gradually reintroduce healthy foods and physical activity, continuing with support and possibly weight-loss medicine if needed. This support and monitoring continues for the full two years.

If you're in the surgery group, you would have standard weight-loss surgery, such as a gastric bypass or sleeve gastrectomy, and be monitored according to usual care. For both groups, there will be regular check-ups and assessments to monitor your health and weight loss over the two-year period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your health, and both treatments aim to improve your health and quality of life through weight loss. However, the intensive weight loss programme requires significant commitment to dietary changes. Weight-loss surgery, like any operation, carries risks such as complications from anaesthesia or the surgery itself, though these are typically discussed in detail with your medical team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

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

Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
Verified postcode
Aarhus, Denmark· Recruiting
The Department of Medicine and Department of Surgery, University Hospital of South West Jutland
Verified postcode
Esbjerg, Denmark· Recruiting
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Verified postcode
Hvidovre, Denmark· Recruiting
Department of Surgery, Viborg Regional Hospital
Verified postcode
Viborg, Denmark· Recruiting
St Richard's Hospital
Verified postcode
Chichester, United Kingdom· Recruiting
Hartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
Verified postcode
Birmingham, United Kingdom· Recruiting
Southmead Hospital, North Bristol NHS Trust
Verified postcode
Bristol, United Kingdom· Recruiting
The Whittington Hospital
Verified postcode
London, United Kingdom· Recruiting
Sunderland Royal Hospital
Verified postcode
Sunderland, United Kingdom· Recruiting
Musgrove Park Hospital, Somerset Foundation NHS Trust
Verified postcode
Taunton, United Kingdom· Recruiting

Common questions

What is 'severe and complex obesity'?

This refers to a high level of obesity, often with other health problems linked to it, making it more challenging to manage.

What is 'bariatric surgery'?

Bariatric surgery is a type of operation that helps people lose weight by making changes to their digestive system, such as gastric bypass or sleeve gastrectomy.

What's an 'intensive weight loss intervention'?

It's a structured programme that usually includes strict diets (like meal replacements), support for changing eating and exercise habits, and sometimes medications to help with weight loss.

Will I get to choose my treatment?

No, if you join the study, you'll be assigned to either the intensive weight loss programme or surgery by chance. This helps make the study results fair.

How long will I be in the study?

The intervention phase for the intensive weight loss group lasts two years. Follow-up and monitoring will occur over this period for both groups.

How to find out more

Kirstine N Bojsen-Møller, MD, PhD

kirstine.nyvold.bojsen-moeller@regionh.dk +45 3862 3862 Official trial record

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