A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults accessing NHS Tier 3 weight management services for treatment of severe obesity: a multi-centre, two-arm, individually randomised controlled, assessor-blinded, adaptive superiority trial with parallel process evaluation and health economic evaluation

niversity Hospitals Plymouth NHS Trust0 sites990 target enrollmentAugust 25, 2023

Overview

No summary available.

Registry

who.int

Start Date

August 25, 2023

End Date

April 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals Plymouth NHS Trust

•Patients must satisfy these criteria to be considered for the study:
•1\. Referred to the T3WMS within the last 6 months OR if referred to the T3WMS more than 6 months ago there is a clinically confirmed weight and BMI within the last 6 months.
•2\. In individuals with with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African\-Caribbean family background, Body Mass Index \> \= 37\.5 kg/m2 or Body Mass Index \> \= 32\.5 kg/m2 with at least one significant comorbidity.
•In all other individuals, Body Mass Index \> \= 40 kg/m2 or Body Mass Index \> \= 35 kg/m2 with at least one significant comorbidity.
•Patients must satisfy all of the following criteria to be enrolled in the study:
•1\. Registered with the T3WMC
•2\. In individuals with with a South Asian, Chinese, other Asian, Middle Eastern, Black African or African\-Caribbean family background, Body Mass Index \> \= 37\.5 kg/m² or Body Mass Index \> \= 32\.5 kg/m² with at least one significant comorbidity at the point of consent.
•In all other individuals, Body Mass Index \> \= 40 kg/m² or Body Mass Index \> \= 35 kg/m² with at least one significant comorbidity at the point of consent.
•3\.Aged \> \= 18 years
•4\. Willing to be randomised to either PROGROUP or usual care

•Patients who meet any of the following criteria will be excluded from study participation:
•1\. Already undergone bariatric surgery
•2\.Are scheduled, or have made their own plans, to undergo bariatric surgery during the course of the trial.
•3\. Currently taking the following pharmacotherapy for the indication of weight loss: Semaglutide, Liraglutide, Orlistat, or any off\-licence weight\-reducing pharmacotherapy such as the stimulant appetite suppressants phentermine and diethylpropion. Commencing these medications from six months post\-randomisation is allowable, consistent with NICE guideline 189, 1\.8\.1: ‘consider pharmacological treatment only after dietary, exercise and behavioural approaches have been started and evaluated’.
•4\. Currently engaged in any other weight management trial
•5\. Unwilling or unable to attend group sessions
•6\. Intending to relocate outside the geographical region during the trial period
•7\. Participants who have significant difficulties in adequate understanding of English, or a sensory impairment, such that they are unable to sufficiently understand/access the trial documentation or engage in group sessions, in the absence of a local provision of translated materials or communication aids.