Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

Prior treatment

• Prior bariatric surgery, not including laparoscopic gastric banding, intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed \>1 year before screening.

Other illness

• Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• Diagnosis of or treatment for severe eating disorder within the last 6 months.
• 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.
• Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
• Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)

Other

• Intending to become pregnant in the next two years or pregnant or breastfeeding.
• Use of WLM or GLP-1 agonist treatment within the last three months.
• Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
• Another member of the household enrolled in the trial.

• Age ≥18 years and ≤60 years old at screening.
• Has severe and complex obesity i.e. BMI\>35 or \>32.5 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds and with one or more of these specific adiposity-related chronic diseases of cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea.
• Provides informed consent.

Criteria the registry did not label

• Please note that participants need to be invited in order to take part in the trial