Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321458
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-03-13
Brief Title:
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity
Sponsor:
Carsten Dirksen
Organization:
Copenhagen University Hospital Hvidovre
Study Overview
Official Title:
Intensive Weight Loss Intervention Versus Usual Care for Adults With Severe and Complex Obesity the LightWAY Randomised Trial Lighthouse Consortium on Obesity Management LightCOM Trial no 3
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LightWAY
Brief 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
Detailed Description:
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 participants 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 physiotherapistsexercise therapists and include psychological support
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 participants 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 physiotherapistsexercise therapists and include psychological support
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None