{
  "abstract": "Introduction Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.Methods and analysis LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m 2 with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.Ethics and dissemination Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.Trial registration number NCT06321458.",
  "authors": [
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK"
      ],
      "name": "Sarah Wane"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK"
      ],
      "name": "Paul Aveyard"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark"
      ],
      "name": "Sabrina Wielsøe"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Sofus Christian Larsen"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK"
      ],
      "name": "Jadine Scragg"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Jane Lindschou"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark",
        "Department of Regional Health Research, University of Southern Denmark Faculty of Health Sciences, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Janus Christian Jakobsen"
    },
    {
      "affiliations": [
        "Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital Rigshospitalet, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Janus Engstrøm"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Ina Olmer Specht"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Ann-Kathrin Lindahl Christiansen"
    },
    {
      "affiliations": [
        "Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Aksel Karl Georg Jensen"
    },
    {
      "affiliations": [
        "Department of Clinical Research, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark",
        "Physical Medicine & Rehabilitation Research - Copenhagen (PMR-C), Department of Physical and Occupational Therapy, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark",
        "Department of Orthopedic Surgery, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark"
      ],
      "name": "Thomas Bandholm"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK"
      ],
      "name": "Charlotte Albury"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Gritt Overbeck"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Susanne Reventlow"
    },
    {
      "affiliations": [
        "Department of Public Health, DaCHE, University of Southern Denmark, Odense, Region Syddanmark, Denmark"
      ],
      "name": "Kim Rose Olsen"
    },
    {
      "affiliations": [
        "Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England, UK"
      ],
      "name": "Patrick Farr"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Kirstine Nyvold Bojsen-Møller"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark",
        "Research Unit for Diet and Health at The Parker Institute, Frederiksberg and Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Berit Lilienthal Heitmann"
    },
    {
      "affiliations": [
        "Section of General Practice and Research Unit for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Capital Region of Denmark, Denmark"
      ],
      "name": "Frans Boch Waldorff"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, Denmark",
        "Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "Sten Madsbad"
    },
    {
      "affiliations": [
        "Department of Respiratory Diseases and Endocrinology, Amager and Hvidovre Hospital, Copenhagen University Hospital Hvidovre, Hvidovre, Capital Region of Denmark, 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, England, UK"
      ],
      "name": "Susan Ann Jebb"
    }
  ],
  "title": "Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol",
  "uid": "3697ffe0-da02-5f7f-bc05-c7e790dcf421"
}