Swancutt Dawn, Tarrant Mark, Ingram Wendy, Baldrey Sarah, Burns Lorna, Byng Richard, Calitri Raff, Creanor Siobhan, Dean Sarah, Evans Lucy, Gill Laura, Goodwin Elizabeth, Hawkins Lily, Hayward Chris, Hind Sarah, Hollands Laura, Hosking Joanne, Lloyd Jenny, Moghadam Shokraneh, Neilens Helen, O'Kane Mary, Perry Steve, Sheaff Rod, Spencer Anne, Taylor Adrian, Ward Thomas, Watkins Ross, Wilding John, Pinkney Jonathan
University of Plymouth, Faculty of Health, University of Plymouth, Plymouth Science Park, Plymouth, PL6 8BX, UK.
University of Exeter, College of Medicine and Health, St Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
Pilot Feasibility Stud. 2022 Sep 10;8(1):206. doi: 10.1186/s40814-022-01167-0.
Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity.
This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted.
This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients.
ISRCTN number 22088800.
英国约有1500万人患有肥胖症，其中约500万人患有重度肥胖症（体重指数（BMI）≥35kg/m²）。患有重度肥胖症会显著损害健康、幸福感和生活质量，并大幅缩短预期寿命。体重减轻可预防或改善这些不良后果，而持续的行为改变是治疗的基石。尽管英国国家医疗服务体系（NHS）的专科“三级”体重管理服务（T3WMS）通过个体化和基于小组的治疗方式为重度肥胖症患者提供支持，但目前关于最佳干预设计和效果的证据有限。由于重度肥胖症存在异质性，需要针对个体需求进行个性化治疗。尽管存在这种异质性，但有充分理由怀疑，与常规护理相比，结构化的基于小组的行为干预可能对重度肥胖症的治疗更有效且更具成本效益。本研究的目的是测试开展一项多中心随机对照临床试验的可行性，该试验旨在比较基于小组的行为干预与重度肥胖症患者的常规护理。
这项可行性随机对照研究是一项部分整群多中心试验，比较PROGROUP（一种新型的基于小组的行为干预）与常规护理。年龄≥18岁、新被NHS T3WMS转诊并接受的成年人，若BMI≥40或BMI≥35kg/m²且伴有合并症、适合接受基于小组的护理且愿意被随机分组，则符合入选标准。排除标准包括参与另一项体重管理研究、在试验期间计划进行减肥手术，以及不愿意或无法参加小组会议。结果评估人员将对治疗分配不知情，并且将评估设盲的成功性。将在随机分组后的基线、6个月和12个月收集临床指标。次要结果指标将通过自我报告并远程收集。将进行过程评估和经济学评估。
这项随机可行性研究旨在测试所有必需的研究程序，并额外探索三个关键问题；在参与的NHS T3WMS实施一项复杂试验的可行性、对多学科医疗团队进行标准干预培训，以及这种小组干预对这些特别复杂患者的可接受性。
国际标准随机对照试验编号22088800。
