Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
Recruiting now · Not applicable
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT06321458
- Run by
- Carsten Dirksen
- People needed
- 600
- Starts
- 2024-04-29
- Expected to finish
- 2048-12-01
- Last updated by the study team
- 2025-12-01
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
- 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.
- 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)
- Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
- Another member of the household enrolled in the trial.
Where it is running
- Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse — Hvidovre, Denmark (enrolling)
- Yorkshire and Humber RRDN (Leeds, Sheffield and Hull) — Leeds, United Kingdom (enrolling)
- The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre — Hvidovre, Denmark (enrolling)
- Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering — Søborg, Denmark (enrolling)
- The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg — Frederiksberg, Denmark (enrolling)
- University Hospitals of Derby and Burton NHS Foundation Trust — Derby, United Kingdom (enrolling)
- Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet — Frederiksberg, Denmark (enrolling)
- Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
- East of England RRDN — Ipswich, 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.