Intensive weight loss program for adults with severe 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
This study is testing whether a two-year intensive weight loss program can help adults with severe obesity lose weight more effectively than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Copenhagen University Hospital, Hvidovre Academic / other |
| Locations | 14 sites (Frederiksberg and 13 other locations) |
| Trial ID | NCT06321458 on ClinicalTrials.gov |
What this trial studies
This trial compares an intensive weight loss intervention (IWL) with usual care for adults suffering from severe and complex obesity. The IWL lasts two years and includes total dietary replacements, behavioral support, and weight-loss medication, structured in three phases: induction, weight loss continuation, and maintenance. Participants in the usual care group will receive basic information on obesity management and may be referred to local programs. The study aims to evaluate the clinical benefits, harms, and cost-effectiveness of the IWL approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with severe obesity (BMI >35 or >32.5 for certain ethnic backgrounds) and related chronic diseases.
Not a fit: Patients who are pregnant, breastfeeding, or have recently used weight-loss medications or undergone certain bariatric surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve weight management and health outcomes for patients with severe obesity.
How similar studies have performed: Previous studies have shown promising results with intensive weight loss interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Please note that participants need to be invited in order to take part in the trial Inclusion Criteria: 1. Age ≥18 years and ≤60 years old at screening. 2. 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. 3. Provides informed consent. Exclusion Criteria: 1. Intending to become pregnant in the next two years or pregnant or breastfeeding. 2. Use of WLM or GLP-1 agonist treatment within the last three months. 3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer. 4. 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. 5. Diagnosis of or treatment for severe eating disorder within the last 6 months. 6. Any other disease that markedly compromises the participant's ability to adhere to the treatment programme or follow-up or is likely to mean that weight loss will not improve the person's length or quality of life, such as conditions limiting life expectancy. 7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets). 8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis) 9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial. 10. Another member of the household enrolled in the trial.
Where this trial is running
Frederiksberg and 13 other locations
- Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet — Frederiksberg, Denmark (Recruiting)
- The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg — Frederiksberg, Denmark (Recruiting)
- Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse — Hvidovre, Denmark (Recruiting)
- The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre — Hvidovre, Denmark (Recruiting)
- Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering — Søborg, Denmark (Recruiting)
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Not_yet_recruiting)
- University Hospitals of Derby and Burton NHS Foundation Trust — Derby, United Kingdom (Recruiting)
- East of England RRDN — Ipswich, United Kingdom (Not_yet_recruiting)
- Yorkshire and Humber RRDN (Leeds, Sheffield and Hull) — Leeds, United Kingdom (Recruiting)
- South West Peninsula RRDN — Plymouth, United Kingdom (Not_yet_recruiting)
- Powys Teaching Health Board — Powys, United Kingdom (Not_yet_recruiting)
- South Central RRDN — Southampton, United Kingdom (Not_yet_recruiting)
- Torbay and South Devon NHS Trust — Torquay, United Kingdom (Not_yet_recruiting)
- Royal Wolverhampton NHS Trust — Wolverhampton, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Carsten Dirksen, Ass. Prof.
- Email: carsten.dirksen@regionh.dk
- Phone: +45 29425320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.