ISRCTN13721429进行中（未招募）Unknown
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 个研究点目标入组 990 人开始时间: 2023年8月25日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 990
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •5. Willing to be weighed on at least three occasions (baseline, 6 months and 12 months)
- •6. Willing to provide blood samples and blood pressure readings on three occasions (baseline, 6 months and 12 months)
- •7. Considered suitable for group-based care
- •8. Have capacity to consent
排除标准
- •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.
研究者
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