Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity: the LightCARE Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 2
Status: Recruiting
Location: See all (9) 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 obesity class I or uncomplicated obesity class II or higher.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Age ≥18 years and ≤60 years old at screening.
• BMI ≥30 kg/m2 or ≥27.5 kg/m2 in people with South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean family backgrounds (as reported by the participants).
• Informed consent.
Locations
Other Locations
Denmark
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
RECRUITING
Copenhagen
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
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering
RECRUITING
Søborg
United Kingdom
East of England RRDN
RECRUITING
Ipswich
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
RECRUITING
Leeds
North West RRDN
RECRUITING
Manchester
West Midlands RRDN
RECRUITING
Wolverhampton
Contact Information
Primary
Frans B Waldorff, Professor
fransw@sund.ku.dk
+4535327129
Backup
Susan Jebb, Professor
lightcare@phc.ox.ac.uk
Time Frame
Start Date: 2024-06-05
Estimated Completion Date: 2048-12
Participants
Target number of participants: 400
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: usual care in primary care, Tier 2 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