Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity

NCT06321432 | Active Not Recruiting

• 1 other identifier: LightCARE
• Study Type: interventional
• Target: 480
• Locations: 2 countries
• Sites: 10

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Weight

  Weight (kg)

  104 weeks after randomisation

Secondary Outcomes (4)

• Weight loss (20%)

  104 weeks after randomisation

• Short-Form-36, mental component score

  104 weeks after randomisation

• Gait speed

  104 weeks after randomisation

• MetS-Z

  104 weeks after randomisation

Other Outcomes (45)

• Safety - SAE

  104 weeks after randomisation

• Safety - eating disorder

  104 weeks after randomisation

• Safety - bone mineral density (BMD) assessed by DXA

  104 weeks after randomisation

Study Arms (2)

Intensive weight loss intervention

EXPERIMENTAL

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.

Behavioral: Intensive weight loss intervention

Usual care

ACTIVE COMPARATOR

Denmark: usual care offered by the GP or local municipality. The UK: usual care in primary care, Tier 2 weight management services.

Behavioral: Usual care

Interventions

Intensive weight loss intervention BEHAVIORAL

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

Intensive weight loss intervention

Usual care BEHAVIORAL

Usual care

Usual care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Intending to become pregnant in the next two years, or pregnant, or breastfeeding.
• Use of WLM or GLP-1 agonist treatment within the last 3 months.
• Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
• 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.
• Diagnosis or treatment for eating disorder within the last 6 months.
• 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.
• 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).
• Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial.
• Conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis)
• Another member of the household enrolled in the trial.

Sponsors & Collaborators

• Carsten Dirksen: lead
• University of Copenhagen: collaborator
• University of Southern Denmark: collaborator
• University of Oxford: collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (10)

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

Copenhagen, 2650, Denmark

Location

Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

Frederiksberg, 2000, Denmark

Location

The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Frederiksberg, 2000, Denmark

Location

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

Hvidovre, 2650, Denmark

Location

Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

Søborg, 2860, Denmark

Location

West Midlands RRDN

Birmingham, United Kingdom

Location

South West Peninsula RDN, Exeter

Exeter, United Kingdom

Location

Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)

Leeds, United Kingdom

Location

North West RRDN

Manchester, United Kingdom

Location

East of England RRDN

Norwich, United Kingdom

Location

Related Publications (1)

• Larsen SC, Heitmann BL, Wane S, Wielsoe S, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Bojsen-Moller KN, Bandholm T, Overbeck G, Kousgaard MB, Albury C, Reventlow S, Olsen KR, Kongstad LP, Madsbad S, Jebb SA, Dirksen C, Aveyard P, Waldorff FB; LightCOM team. Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial. BMJ Open. 2025 Oct 15;15(10):e107155. doi: 10.1136/bmjopen-2025-107155.

  PMID: 41093354 DERIVED

Related Links

• LightCOM website

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carsten Dirksen, Ass. Prof.

  Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed. Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee ill write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: June 5, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2048
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When the results have been published
• Access Criteria: Researchers with a protocol for their planned study

Locations

DK (5); GB (5)