Intensive weight loss intervention: Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care: Usual care
Study summary
In this trial, the aim is to assess the clinical benefits and harms, as well as cost-effectiveness of an intensive weight loss (IWL) intervention that includes total dietary replacements, behavioural support and weight-loss medication compared with existing weight management programmes within primary care for people with severe and complex obesity.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Please note that participants need to be invited in order to take part in the trial
Inclusion Criteria:
1. Age ≥18 years and ≤60 years old at screening.
2. 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.
3. Provides informed consent.
Exclusion Criteria:
1. Intending to become pregnant in the next two years or pregnant or breastfeeding.
2. Use of WLM or GLP-1 agonist treatment within the last three months.
3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
4. 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.
5. Diagnosis of or treatment for severe eating disorder within the last 6 months.
6. 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.
7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
10. Another member of the household enrolled in the trial.
Primary outcome measure(s)
MetS-Z — 104 weeks after randomisation Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)
Weight — 104 weeks after randomisation Weight (kg)
Trial sites (14)
Facility
City
Region
Status
Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet
Frederiksberg
Denmark
The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Frederiksberg
Denmark
Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse
Hvidovre
Denmark
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre
Denmark
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
Søborg
Denmark
Cwm Taf Morgannwg University Health Board
Abercynon
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
United Kingdom
University Hospitals of Derby and Burton NHS Foundation Trust
Derby
United Kingdom
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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