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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
LightCOM
Study
lightcare@phc.ox.ac.uk
Prof
Susan
Jebb
Susan.jebb@phc.ox.ac.uk
Kathryn
Hubbard
kathryn.hubbard@phc.ox.ac.uk
Obesity and other hyperalimentation
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People living with obesity are at increased risk of ill-health. It can worsen their quality of life, puts pressure on healthcare resources and reduces economic productivity. Research has identified a number of treatments that can help people lose enough weight to improve their health, but only a small proportion of people are offered treatment within the NHS. In most cases treatment is only provided for short periods, normally 12 weeks, or sometimes up to a year, and it is common for people to put weight back on when these programmes end.
This trial is being run in both Denmark and the UK, and the intervention will be delivered by specialist weight management hubs. Initially patients will be encouraged to use a low-energy total diet replacement (TDR) programme. Research shows this leads to an average weight loss of 15% after 6 months, followed by gradual weight regain. If weight loss is less than expected, patients will be offered weight loss medications, with the aim of them being able to lose 20% of their starting weight, and maintain this weight loss, for 2 years. We will compare this new approach to weight management with what is already offered in primary care for people living with obesity.
This trial will establish whether this new approach to weight management is acceptable and sustainable for participants, practical for existing healthcare systems to use, whether it leads to improved outcomes for patients and if it is good value for money.
This trial is part of a programme of work to test this intervention in three different sets of people with varying levels of obesity and associated health conditions. In this trial we will test whether this new, combined intervention of TDR, weight loss medication and coaching can lead to people losing more weight compared with the weight management programmes that are already available within primary and secondary care for people with complex and severe obesity.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;Dietary;Psychological & Behavioural;
You can take part if:
You may not be able to take part if:
A participant will not be eligible for the trial if the person meets any of the following criteria: 1. Have severe and complex obesity, i.e. obesity BMI of 35 or greater if white or 32.5 if non-white, and with one or more of these specific adiposity-related comorbidities: cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatohepatitis, or sleep apnoea. 2. Are intending to become pregnant in the next two years, or pregnant, or breastfeeding. 3. Have used weight loss medication or GLP-1 agonist treatment within the last 3 months. 4. Are currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer. 5. Have had prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed within 1 year before screening. 6. Diagnosis or treatment for eating disorder within the last 6 months 7. Have any other disease that markedly compromises the participant’s ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person’s length or quality of life, such as conditions limiting life expectancy. 8. Have any conditions that contraindicate or complicate total diet replacement (including diabetes requiring basal bolus insulin therapy or insulin pump therapy, phenylketonuria, coeliac disease, or other conditions requiring special diets). 9. People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial 10. Have any conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis) 11. Another member of the household enrolled in the trial.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Kathryn
Hubbard
kathryn.hubbard@phc.ox.ac.uk
Prof
Susan
Jebb
Susan.jebb@phc.ox.ac.uk
LightCOM
Study
lightcare@phc.ox.ac.uk
The study is sponsored by Copenhagen University Hospital and funded by NOVO NORDISK FONDEN (Denmark) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 58193
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