Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity: the LightWAY Randomised Trial: Lighthouse Consortium on Obesity Management (LightCOM) Trial no 3
Carsten Dirksen
600 participants
Apr 29, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Please note that participants need to be invited in order to take part in the trial
- 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.
Exclusion Criteria10
- 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.
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Interventions
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care
Locations(14)
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NCT06321458