Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCarsten Dirksen
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Intensive weight loss intervention
- Usual care
Treatment groups
600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Carsten Dirksen
Lead sponsor
Copenhagen University Hospital, Hvidovre
Sponsor institution
University of Copenhagen
Collaborator
University of Southern Denmark
Collaborator
University of Oxford
Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov