Intensive Weight Loss Intervention Versus Usual Care for Adults With 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

• Has severe and complex obesity, i.e., obesity class II (BMI≥35 if white or 32.5 if non-white) with one or more of these specific adiposity-related comorbidities: cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea (Appendix 1).
• Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• Diagnosis or treatment for 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 total diet replacement (including type 1 diabetes or other diabetes requiring any insulin therapy, phenylketonuria, or other conditions requiring special diets).
• Conditions that contraindicate or complicate GLP-1 or GIP agonist 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 3 months.
• Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial.
• Another member of the household enrolled in the trial.

• Age ≥18 years and ≤60 years old at screening.
• BMI ≥30 kg/m2 or ≥27.5 kg/m2 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds (as reported by the participants).
• Informed consent.

Criteria the registry did not label

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