Clinical trial

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

Active, not recruiting · Not applicable · 2 countries · Registry ID NCT06321458

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry criteria

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.

Treatments and study arms

Intensive weight loss intervention

Behavioral

Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.

Usual care

Behavioral

Usual care

Primary outcomes

MetS-Z104 weeks after randomisation

Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)

Weight104 weeks after randomisation

Weight (kg)

Study locations

14 locations were listed when this page was built. The first 40 are shown.

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)🇬🇧 Leeds, United Kingdom
South West Peninsula RRDN🇬🇧 Plymouth, United Kingdom
Powys Teaching Health Board🇬🇧 Powys, United Kingdom
South Central RRDN🇬🇧 Southampton, United Kingdom
Torbay and South Devon NHS Trust🇬🇧 Torquay, United Kingdom
Royal Wolverhampton NHS Trust🇬🇧 Wolverhampton, United Kingdom