{
  "abstract": "Introduction Total 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.",
  "authors": [
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Part of the Copenhagen University Hospital, Frederiksberg, Denmark"
      ],
      "name": "Sofus Christian Larsen"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Part of the Copenhagen University Hospital, Frederiksberg, Denmark"
      ],
      "name": "Berit Lilienthal Heitmann"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK"
      ],
      "name": "Sarah Wane"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark"
      ],
      "name": "Sabrina Wielsøe"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark"
      ],
      "name": "Jane Lindschou"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark",
        "Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Janus Christian Jakobsen"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark"
      ],
      "name": "Janus Engstrøm"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Part of the Copenhagen University Hospital, Frederiksberg, Denmark"
      ],
      "name": "Ina Olmer Specht"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Ann-Kathrin Lindahl Christiansen"
    },
    {
      "affiliations": [
        "Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Aksel Karl Georg Jensen"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Kirstine Nyvold Bojsen-Møller"
    },
    {
      "affiliations": [
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark",
        "Physical Medicine & Rehabilitation Research - Copenhagen (PMR-C), Department of Physical and Occupational Therapy, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark",
        "Department of Clinical Research, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark",
        "Department of Orthopedic Surgery, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark"
      ],
      "name": "Thomas Bandholm"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Gritt Overbeck"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Marius Brostrom Kousgaard"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK"
      ],
      "name": "Charlotte Albury"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Susanne Reventlow"
    },
    {
      "affiliations": [
        "DaCHE - Danish Centre for Health Economics, University of Southern Denmark Department of Public Health, Odense, Denmark"
      ],
      "name": "Kim Rose Olsen"
    },
    {
      "affiliations": [
        "DaCHE - Danish Centre for Health Economics, University of Southern Denmark Department of Public Health, Odense, Denmark"
      ],
      "name": "Line Planck Kongstad"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark"
      ],
      "name": "Sten Madsbad"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK"
      ],
      "name": "Susan Ann Jebb"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Part of the Copenhagen University Hospital, Hvidovre, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Carsten Dirksen"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford University Hospitals Biomedical Research Centre, Oxford, UK"
      ],
      "name": "Paul Aveyard"
    },
    {
      "affiliations": [
        "Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Frans Boch Waldorff"
    },
    {
      "affiliations": [],
      "name": "on behalf of the LightCOM team"
    }
  ],
  "title": "Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial",
  "uid": "370e1e69-bc9a-5e68-9d34-b7c59641ed8d"
}