RecruitingNot ApplicableNCT06321458

Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

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

Sponsor

Carsten Dirksen

Enrollment

600 participants

Start Date

Apr 29, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This two-year trial (LightWAY) tests an intensive weight loss program — combining total meal replacements, behavioral coaching, and weight-loss medication — against existing standard weight management care for people with severe or complex obesity (BMI above 35, or above 32.5 in certain ethnic backgrounds with a related condition like type 2 diabetes or heart disease). The program moves through three structured phases: a strict meal replacement induction, a gradual return to healthy foods, and a long-term maintenance phase. Adults aged 18–60 in the UK or Denmark who have severe obesity with at least one related health condition and have not recently used weight-loss medications may be eligible; the trial requires a personal invitation to participate. Participation involves two years of structured dietary, behavioral, and medical support, with clinical and quality-of-life assessments at regular intervals. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntensive weight loss intervention

Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.

BEHAVIORALUsual care

Usual care

Locations(14)

Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

Frederiksberg, Denmark

The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Frederiksberg, Denmark

Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse

Hvidovre, Denmark

The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre

Hvidovre, Denmark

Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

Søborg, Denmark

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

University Hospitals of Derby and Burton NHS Foundation Trust

Derby, United Kingdom

East of England RRDN

Ipswich, United Kingdom

Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)

Leeds, 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

Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06321458

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