Actively Recruiting
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
Led by Carsten Dirksen · Updated on 2025-12-01
600
Participants Needed
14
Research Sites
1283 weeks
Total Duration
On this page
Sponsors
C
Carsten Dirksen
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 60 years at screening
- Severe and complex obesity with BMI >35 or >32.5 for specified ethnic groups, plus one or more related chronic diseases (cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnea)
- Provides informed consent
You will not qualify if you...
- Pregnant, breastfeeding, or intending to become pregnant in the next two years
- Use of weight loss medication or GLP-1 agonist treatment within the last three months
- Current treatment for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer
- Prior bariatric surgery excluding certain procedures or if device removed more than one year before screening
- Severe eating disorder diagnosed or treated within the last six months
- Any disease that limits ability to follow the program or limits life expectancy
- Conditions contraindicating total dietary replacement (e.g., type 1 diabetes requiring insulin, phenylketonuria)
- Conditions contraindicating GLP-1 treatment (e.g., history of pancreatitis)
- Participation in other multidisciplinary obesity treatment research
- Another household member enrolled in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet
Frederiksberg, Denmark, 2000
Actively Recruiting
2
The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg
Frederiksberg, Denmark, 2000
Actively Recruiting
3
Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse
Hvidovre, Denmark, 2650
Actively Recruiting
4
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
5
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
Søborg, Denmark, 2860
Actively Recruiting
6
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Not Yet Recruiting
7
University Hospitals of Derby and Burton NHS Foundation Trust
Derby, United Kingdom
Actively Recruiting
8
East of England RRDN
Ipswich, United Kingdom
Not Yet Recruiting
9
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
Leeds, United Kingdom
Actively Recruiting
10
South West Peninsula RRDN
Plymouth, United Kingdom
Not Yet Recruiting
11
Powys Teaching Health Board
Powys, United Kingdom
Not Yet Recruiting
12
South Central RRDN
Southampton, United Kingdom
Not Yet Recruiting
13
Torbay and South Devon NHS Trust
Torquay, United Kingdom
Not Yet Recruiting
14
Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom
Not Yet Recruiting
Research Team
C
Carsten Dirksen, Ass. Prof.
CONTACT
S
Susan Jebb, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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