Intensive Weight Loss Intervention Versus Usual Care for Adults With Obesity

Last updated: May 14, 2025
Sponsor: Carsten Dirksen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Weight Loss

Obesity

Treatment

Usual care

Intensive weight loss intervention

Clinical Study ID

NCT06321432
LightCARE
  • Ages 18-60
  • All Genders

Study 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 obesity class I or uncomplicated obesity class II or higher.

Eligibility Criteria

Inclusion

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 reportedby the participants).

  3. Informed consent.

Exclusion

Exclusion Criteria:

  1. Has severe and complex obesity, i.e., obesity class II (BMI≥35 if white or 32.5 ifnon-white) with one or more of these specific adiposity-related comorbidities:cardiovascular disease, type 2 diabetes, hypertension, non-alcoholic steatosis, orsleep 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 ornon-melanoma skin cancer.

  5. Prior bariatric surgery, not including laparoscopic gastric banding, intragastricballoons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the devicehas 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 tothe treatment programme or follow-up or is likely to mean that weight loss will notimprove the person's length or quality of life, such as conditions limiting lifeexpectancy.

  8. Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring any insulin therapy, phenylketonuria, orother conditions requiring special diets).

  9. Taking part in other research involving multidisciplinary obesity treatment thatwould 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.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Usual care
Phase:
Study Start date:
June 05, 2024
Estimated Completion Date:
December 31, 2048

Study Description

In the LightCARE trial, an intensive weight loss (IWL) intervention will compared with usual care. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication in three phases:

  • 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.

Connect with a study center

  • The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre

    Copenhagen, 2650
    Denmark

    Active - Recruiting

  • Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

    Frederiksberg, 2000
    Denmark

    Active - Recruiting

  • The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

    Frederiksberg, 2000
    Denmark

    Active - Recruiting

  • Hvidovre kommune: Center for Sundhed og Ældre, Hvidovre Sundhedscenter, Sundhed og Forebyggelse

    Hvidovre, 2650
    Denmark

    Active - Recruiting

  • Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

    Søborg, 2860
    Denmark

    Active - Recruiting

  • East of England RRDN

    Ipswich,
    United Kingdom

    Active - Recruiting

  • Yorkshire and Humber RRDN (Leeds, Sheffield and Hull)

    Leeds,
    United Kingdom

    Active - Recruiting

  • North West RRDN

    Manchester,
    United Kingdom

    Active - Recruiting

  • NIHR CRN: Thames Valley and South Midlands

    Oxford,
    United Kingdom

    Site Not Available

  • NIHR RRDN: South Central

    Oxford,
    United Kingdom

    Site Not Available

  • West Midlands RRDN

    Wolverhampton,
    United Kingdom

    Active - Recruiting

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