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Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity

NCT06321458 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-12-01

No results posted yet for this 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 severe and complex obesity.

Conditions

Interventions

BEHAVIORAL

Intensive weight loss intervention

Intensive weight loss intervention, incl. total meal replacements, behavioural support, and weight loss medication.

BEHAVIORAL

Usual care

Usual care

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • University of Oxford

    collaborator OTHER

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Carsten Dirksen

    lead OTHER

Principal Investigators

  • Carsten Dirksen · Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2028-03-31
Completion
2048-12-31

Countries

  • Denmark
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06321458 on ClinicalTrials.gov