Clinical trial
Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity
Active, not recruiting · Not applicable · 2 countries · Registry ID NCT06321432
Active, not recruitingNot applicableInterventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 60 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity
Full registry criteria
Please note that participants need to be invited in order to take part in the trial. Inclusion Criteria: 1. Age ≥18 years and ≤60 years old at screening. 2. 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). 3. Informed consent. Exclusion Criteria: 1. 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). 2. Intending to become pregnant in the next two years, or pregnant, or breastfeeding. 3. Use of WLM or GLP-1 agonist treatment within the last 3 months. 4. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer. 5. 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. 6. Diagnosis or treatment for eating disorder within the last 6 months. 7. 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. 8. 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). 9. Taking part in other research involving multidisciplinary obesity treatment that would compromise participation in this trial. 10. Conditions that contraindicate or complicate GLP-1 or GIP agonist treatment (including history of pancreatitis) 11. Another member of the household enrolled in the trial.
Treatments and study arms
Intensive weight loss intervention
Behavioral
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care
Behavioral
Usual care
Primary outcomes
Weight104 weeks after randomisation
Weight (kg)
Study locations
10 locations were listed when this page was built. The first 40 are shown.
The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre🇩🇰 Copenhagen, Denmark
Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet🇩🇰 Frederiksberg, Denmark
The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg🇩🇰 Frederiksberg, Denmark
Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse🇩🇰 Hvidovre, Denmark
Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering🇩🇰 Søborg, Denmark
West Midlands RRDN🇬🇧 Birmingham, United Kingdom
South West Peninsula RDN, Exeter🇬🇧 Exeter, United Kingdom
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)🇬🇧 Leeds, United Kingdom
North West RRDN🇬🇧 Manchester, United Kingdom
East of England RRDN🇬🇧 Norwich, United Kingdom