Evidence map›Paper›PMID 41093354›Full record

ArticleBMJ open2025

Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial.

Sofus Christian Larsen, Berit Lilienthal Heitmann, Sarah Wane, Sabrina Wielsøe, Jane Lindschou, Janus Christian Jakobsen, Janus Engstrøm, Ina Olmer Specht, Ann-Kathrin Lindahl Christiansen, Aksel Karl Georg Jensen and 14 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06321432 (Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06321432 naactive not recruitingnot on this map

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

TypeinterventionalSponsorCarsten DirksenRan2024 to 2048Enrolled480ConditionsObesityArmsIntensive weight loss intervention, Usual care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Sofus Christian LarsenResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark sofus.larsen@regionh.dk.ORCID 0000-0002-0838-9378
Berit Lilienthal HeitmannResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-6809-4504
Sarah WaneNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK.ORCID 0000-0002-1766-882X
Sabrina WielsøeDepartment of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark.
Jane LindschouCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Janus Christian JakobsenCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Janus EngstrømCopenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Ina Olmer SpechtResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-3114-4715
Ann-Kathrin Lindahl ChristiansenResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0003-3917-9151
Aksel Karl Georg JensenSection of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Kirstine Nyvold Bojsen-MøllerDepartment of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark.
Thomas BandholmDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0001-6884-1971
Gritt OverbeckResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Marius Brostrom KousgaardResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
Charlotte AlburyNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK.
Susanne ReventlowResearch Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-4990-142X
Kim Rose OlsenDaCHE - Danish Centre for Health Economics, University of Southern Denmark Department of Public Health, Odense, Denmark.
Line Planck KongstadDaCHE - Danish Centre for Health Economics, University of Southern Denmark Department of Public Health, Odense, Denmark.ORCID 0000-0002-9625-5870
Sten MadsbadDepartment of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark.
Susan Ann JebbNuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK.ORCID 0000-0001-9190-2920
Carsten DirksenDepartment of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark.
Paul Aveyard *Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK.
Frans Boch Waldorff *Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
LightCOM team

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTotal diet replacements (TDRs) and weight loss medications (WLMs) have proven effective in producing substantial weight loss for individuals with obesity. Evidence is lacking on whether combining these treatments is effective and cost-effective in primary care for adults with obesity class I (body mass index (BMI) 30-34.9) or uncomplicated obesity class II or higher (BMI≥35 without obesity-related disease). METHODS AND ANALYSIS: LightCARE is a 2-year 1:1 randomised, parallel-group, clinical superiority trial with blinded outcome assessment evaluating the benefits and harms of an intensive weight loss (IWL) intervention compared with usual care for adults with obesity in Denmark and the UK. The trial will include 400 participants aged 18-60 years with obesity class I or uncomplicated obesity class II or higher. The IWL programme aims to achieve and maintain a weight loss of ≥20% through a flexible and individualised combination of TDR, behavioural support, including physical activity and sleep guidance, and WLM if needed and will continue for 2 years. The control group will receive usual care offered in each country, typically consisting of brief behavioural support for weight loss. The primary outcome is body weight 2 years after randomisation. Secondary outcomes will include the proportion of participants achieving ≥20% weight loss, Short-Form-36 Mental Component Score, 4-m gait speed and Metabolic Syndrome Severity-Z score. Serious adverse events, the incidence of eating disorders and bone mineral density will be evaluated as safety outcomes. We will also examine the cost-effectiveness of the intervention, within the trial and in the longer term through modelling. We will conduct a process evaluation to inform any future implementation. ETHICS AND DISSEMINATION: Ethical approval was granted in Denmark (December 2023, H-23051332) and the UK (August 2024, 24/SC/0210). Findings from the trial will be disseminated through peer-reviewed journals and scientific conferences. TRIAL REGISTRATION NUMBER: NCT06321432.

Indexed as

ObesityWeight LossWeight Reduction ProgramsAdolescentAdultAnti-Obesity AgentsBody Mass IndexCost-Benefit AnalysisDenmarkEquivalence Trials as TopicFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicUnited KingdomAnti-Obesity AgentsDrug TherapyNUTRITION & DIETETICSObesityRandomized Controlled Trial

Identifiers

PMID41093354
PMCPMC12530373

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.