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

NCT06321458 | Recruiting

• 1 other identifier: LightWAY
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 14

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 severe and complex obesity.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• MetS-Z

  Metabolic syndrome severity Z-score (scale from -4 to 4, mean is 0, higher scores indicate a worse outcome)

  104 weeks after randomisation

• Weight

  Weight (kg)

  104 weeks after randomisation

Secondary Outcomes (3)

• Short-Form-36, mental component score

  104 weeks after randomisation

• Gait speed

  104 weeks after randomisation

• Weight loss (20%)

  104 weeks after randomisation

Other Outcomes (44)

• SAE

  104 weeks after randomisation

• Incident eating disorders

  104 weeks after randomisation

• 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: tier 3 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.
• 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.
• Provides informed consent.

You may not qualify if:

• Intending to become pregnant in the next two years or pregnant or breastfeeding.
• Use of WLM or GLP-1 agonist treatment within the last three 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 of or treatment for severe 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 TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
• Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
• Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
• 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 (14)

Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

Frederiksberg, 2000, Denmark

RECRUITING

The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Frederiksberg, 2000, Denmark

RECRUITING

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

Hvidovre, 2650, Denmark

RECRUITING

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

Hvidovre, 2650, Denmark

RECRUITING

Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

Søborg, 2860, 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

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

  Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

  STUDY CHAIR

Central Study Contacts

Carsten Dirksen, Ass. Prof.

CONTACT

+45 29425320; carsten.dirksen@regionh.dk

Susan Jebb, Professor

CONTACT

lightway@phc.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model 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 will 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.

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2048
• Last Updated: December 1, 2025

Record last verified: 2025-11

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

GB (9); DK (5)