Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet
RECRUITING
Frederiksberg
The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg
RECRUITING
Frederiksberg
Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse
RECRUITING
Hvidovre
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
RECRUITING
Hvidovre
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
RECRUITING
Søborg
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
NOT_YET_RECRUITING
Birmingham
University Hospitals of Derby and Burton NHS Foundation Trust
NOT_YET_RECRUITING
Derby
East of England RRDN
NOT_YET_RECRUITING
Ipswich
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
NOT_YET_RECRUITING
Leeds
Powys Teaching Health Board
NOT_YET_RECRUITING
Powys
Contact Information
Primary
Carsten Dirksen, Ass. Prof.
carsten.dirksen@regionh.dk
+45 29425320
Backup
Susan Jebb, Professor
lightway@phc.ox.ac.uk
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2048-12
Participants
Target number of participants: 600
Treatments
Experimental: Intensive weight loss intervention
The intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication. The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total.
Active_comparator: Usual care
Denmark: usual care offered by the GP or local municipality. The UK: tier 3 weight management services.
Related Therapeutic Areas
Sponsors
Leads: Carsten Dirksen
Collaborators: University of Southern Denmark, Copenhagen Trial Unit, Center for Clinical Intervention Research, University of Copenhagen, University of Oxford

This content was sourced from clinicaltrials.gov