Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity
NCT ID: NCT06321432
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-06-05
2048-12-31
Brief Summary
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Detailed Description
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* Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.
* Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).
* Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance.
Usual care will differ between the two countries (Denmark and the United Kingdom).
In Denmark, participants will receive a pamphlet on current obesity management guidelines from the Danish National Board of Health, and will be advised to contact their GP for potential referral to local municipality-based obesity management programmes. Furthermore, a notification will be sent to the participant's GP, informing that the participant has been enrolled in the trial and is randomised to usual care. The availability and structure of current obesity programmes varies between municipalities.
In the United Kingdom, participants will be offered to discuss weight management programmes available in their area with their GP practice; the programmes available referral routes vary slightly from place to place. Tier 2 weight management services are mostly commissioned by local authority, and therefore differ slightly across the 333 local authorities in England. These local community-based weight management services provide diet, nutrition, behavioural advice.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Statisticians and investigators drawing conclusions will be fully blinded. The statistical analyses will be conducted with the intervention groups coded as e.g., 'A' and 'B'. The Steering Committee ill write two abstracts while the blinding is intact; one assuming the experimental intervention group is 'A' and the control intervention group is 'B', and one assuming the opposite. After these two abstracts have both obtained consensus, the code will be broken by the data manager.
Study Groups
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Intensive weight loss intervention
The intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication. The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total.
Intensive weight loss intervention
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care
Denmark: usual care offered by the GP or local municipality. The UK: usual care in primary care, Tier 2 weight management services.
Usual care
Usual care
Interventions
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Intensive weight loss intervention
Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.
Usual care
Usual care
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
University of Southern Denmark
OTHER
University of Oxford
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Carsten Dirksen
OTHER
Responsible Party
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Carsten Dirksen
Associate Professor
Principal Investigators
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Carsten Dirksen, Ass. Prof.
Role: STUDY_CHAIR
Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Locations
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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
East of England RRDN
Ipswich, , United Kingdom
Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)
Leeds, , United Kingdom
North West RRDN
Manchester, , United Kingdom
West Midlands RRDN
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Carsten Dirksen
Role: primary
Addie J Frederiksen
Role: primary
Sofus C Larsen
Role: primary
Maria Bleiback Clausen
Role: primary
Julie Borgen Braget
Role: primary
Susan Jebb
Role: primary
Susan Jebb
Role: primary
Susan Jebb
Role: primary
Susan Jebb
Role: primary
References
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Larsen SC, Heitmann BL, Wane S, Wielsoe S, Lindschou J, Jakobsen JC, Engstrom J, Specht IO, Christiansen AL, Jensen AKG, Nyvold Bojsen-Moller K, Bandholm T, Overbeck G, Kousgaard MB, Albury C, Reventlow S, Olsen KR, Kongstad LP, Madsbad S, Jebb SA, Dirksen C, Aveyard P, Waldorff FB; LightCOM team. Intensive weight loss intervention versus usual care in adults with obesity: a protocol for the LightCARE randomised clinical trial. BMJ Open. 2025 Oct 15;15(10):e107155. doi: 10.1136/bmjopen-2025-107155.
Related Links
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LightCOM website
Other Identifiers
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LightCARE
Identifier Type: -
Identifier Source: org_study_id
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