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ObesityLightCARENCT06321432

Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity

A study testing Intensive weight loss intervention in people with Obesity, run by Carsten Dirksen at 10 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obesity
What is being tested?
Intensive weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
10 sitesin 2 countries
Study dates
5 Jun 2024to Dec 2048
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Denmark5 sites

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

    Copenhagen, 2650

  • Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

    Frederiksberg, 2000

  • The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

    Frederiksberg, 2000

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

    Hvidovre, 2650

  • Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

    Søborg, 2860

Other trials in Denmark

United Kingdom5 sites

  • West Midlands RRDN

    Birmingham

  • South West Peninsula RDN, Exeter

    Exeter

  • Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)

    Leeds

  • North West RRDN

    Manchester

  • East of England RRDN

    Norwich

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

In the LightCARE trial, an intensive weight loss (IWL) intervention will compared with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:

  • Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.
  • Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).
  • Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.

Usual care will differ between the two countries (Denmark and the United Kingdom).

In Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.

In the United Kingdom, participants will be offered to discuss weight management programmes available in their area with their GP practice; the programmes available referral routes vary slightly from place to place. Tier 2 weight management services are mostly commissioned by local authority, and therefore differ slightly across the 333 local authorities in England. These local community-based weight management services provide diet, nutrition, behavioural advice.

Conditions
Obesity
Being tested
Intensive weight loss intervention, Usual care
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive weight loss interventionBehavioural

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

  • Usual careBehavioural

    Usual care

Study groups in NCT06321432
Study groupRoleWhat they receive
Intensive weight loss interventionExperimentalThe 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.
Receives: Behavioral: Intensive weight loss intervention
Usual careActive comparatorDenmark: usual care offered by the GP or local municipality. The UK: usual care in primary care, Tier 2 weight management services.
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Weight (kg)

    Measured: 104 weeks after randomisation

Secondary outcomes (4)

  1. Weight loss (20%)

    Proportion of participants with weight loss ≥20%

    Measured: 104 weeks after randomisation

  2. Short-Form-36, mental component score

    Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)

    Measured: 104 weeks after randomisation

  3. Gait speed

    4-metre gait speed (m/s)

    Measured: 104 weeks after randomisation

  4. MetS-Z

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

    Measured: 104 weeks after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2024
  2. Study start5 Jun 2024
  3. Primary completionJan 2028 (estimated)
  4. Study completionDec 2048 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06321432
Sponsor's protocol ID
LightCARE
Acronym
LightCARE
Status last verified
Feb 2026
First submitted
13 Mar 2024
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After the results have been published, the aim is to make a depersonalised dataset publicly available on e.g. ClinicalTrials.gov and/or the European Union (EU) Zenodo database (https://zenodo.org/). The final choice will reflect which platform(s) that are compliant with current legislation at that time

Publications

  • 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.

    PubMed 41093354

Questions about this trial

What is this clinical trial studying?

A study testing Intensive weight loss intervention in people with Obesity, run by Carsten Dirksen at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 104 weeks after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06321432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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