Intensive weight loss intervention for adults with obesity

Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity: the LightCARE Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 2

This study is testing whether a two-year intensive weight loss program can help adults with obesity lose weight more effectively than standard care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Copenhagen University Hospital, Hvidovre (Academic / other)
• Locations: 9 sites (Copenhagen and 8 other locations)
• Trial ID: NCT06321432 on ClinicalTrials.gov

What this trial studies

This trial compares an intensive weight loss intervention (IWL) with usual care for adults with obesity. The IWL lasts two years and includes total dietary replacements, behavioral support, and weight-loss medication across three phases: induction, weight loss continuation, and maintenance. Participants in the usual care group will receive standard obesity management guidance based on local practices in Denmark and the UK. 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 a BMI of 30 kg/m2 or higher, or 27.5 kg/m2 or higher for certain ethnic backgrounds.

Not a fit: Patients with severe obesity-related comorbidities or those who have had prior bariatric surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to significant weight loss and improved health outcomes for patients with obesity.

How similar studies have performed: Other studies have shown success with intensive weight loss interventions, indicating potential for positive outcomes in this approach.

Eligibility 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. 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).
3. Informed consent.

Exclusion Criteria:

1. Has severe and complex obesity, i.e., obesity class II (BMI≥35 if white or 32.5 if non-white) with one or more of these specific adiposity-related comorbidities: cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, or sleep apnoea (Appendix 1).
2. Intending to become pregnant in the next two years, or pregnant, or breastfeeding.
3. Use of WLM or GLP-1 agonist treatment within the last 3 months.
4. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
5. 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.
6. Diagnosis or treatment for eating disorder within the last 6 months.
7. 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.
8. Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring any insulin therapy, phenylketonuria, or other conditions requiring special diets).
9. Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial.
10. Conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis)
11. Another member of the household enrolled in the trial.

Where this trial is running

Copenhagen and 8 other locations

• The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre — Copenhagen, Denmark (Recruiting)
• 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)
• Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering — Søborg, Denmark (Recruiting)
• East of England RRDN — Ipswich, United Kingdom (Recruiting)
• Yorkshire and Humber RRDN (Leeds, Sheffield and Hull) — Leeds, United Kingdom (Recruiting)
• North West RRDN — Manchester, United Kingdom (Recruiting)
• West Midlands RRDN — Wolverhampton, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Frans B Waldorff, Professor

Conditions Obesity