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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2048-12-31

Brief Summary

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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.

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Detailed Description

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In the LightWAY trial, an intensive weight loss (IWL) intervention will be compared with 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 are eligible for referral into an NHS Tier 3 weight management service. These services are commissioned by integrated care boards, and can therefore differ slightly across the 42 regions within the UK. These are specialist weight management clinics that provide non-surgical, intensive medical management with a multidisciplinary approach to care. These clinics often consist of specialist doctors, nurses, dieticians and physiotherapists/exercise therapists, and include psychological support.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Due to the nature of the interventions, it will not be possible to blind the participants or the healthcare providers administering the interventions. In all other aspects of the trial, blinding will be employed. Outcome assessors will be blinded to group allocation. Participants will also be requested not to disclose their allocation when outcomes are assessed.

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 will 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Intensive weight loss intervention

Intervention Type BEHAVIORAL

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: tier 3 weight management services.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years and ≤60 years old at screening.
2. 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.
3. Provides informed consent.

Exclusion Criteria

1. Intending to become pregnant in the next two years or pregnant or breastfeeding.
2. Use of WLM or GLP-1 agonist treatment within the last three months.
3. Currently being treated for cancer other than oestrogen antagonist therapy or non-melanoma skin cancer.
4. 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.
5. Diagnosis of or treatment for severe eating disorder within the last 6 months.
6. 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.
7. Conditions that contraindicate or complicate TDR (including type 1 diabetes or other diabetes requiring insulin therapy, phenylketonuria, or other conditions requiring special diets).
8. Conditions that contraindicate or complicate GLP-1 treatment (including history of pancreatitis)
9. Taking part in other research involving multidisciplinary obesity treatment would compromise participation in this trial.
10. Another member of the household enrolled in the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Carsten Dirksen

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carsten Dirksen

Role: STUDY_CHAIR

Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre

Locations

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Frederiksberg kommune: Social-, Sundheds- og Arbejdsmarkedsområdet

Frederiksberg, , Denmark

Site Status RECRUITING

The Parker Institute, Copenhagen University Hospital - Bispebjerg and Frederiksberg

Frederiksberg, , Denmark

Site Status RECRUITING

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

Hvidovre, , Denmark

Site Status RECRUITING

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

Hvidovre, , Denmark

Site Status RECRUITING

Gladsaxe kommune: Social- og Sundhedsforvaltningen, Sundhed og Rehabilitering

Søborg, , Denmark

Site Status RECRUITING