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Study protocol of a randomised controlled feasibility study of food-related computerised attention training versus mindfulness training and waiting-list control for adults with overweight or obesity.
Trials ( IF 2.5 ) Pub Date : 2020-01-10 , DOI: 10.1186/s13063-019-3932-0
Daniela Mercado 1 , Jessica Werthmann 2 , Iain C Campbell 1 , Ulrike Schmidt 1, 3
Affiliation  

BACKGROUND Obesity is a highly prevalent condition with multiple adverse health consequences. Widely available first-line treatments for obesity, such as dietary and other lifestyle interventions, typically have only short-term effects. Thus, new treatment approaches are needed. Novel interventions such as Attention Bias Modification Training (ABMT) and mindfulness-based interventions focus on modifying different maladaptive cognitive patterns typically present in people with obesity (e.g. attention bias to food cues); however, their mechanisms of action remain largely unknown. We describe the theoretical basis and the rationale for a study protocol of a feasibility randomised controlled trial (RCT) comparing two attention trainings (ABMT vs Mindfulness Training [MT]) in people with overweight or obesity. The aim of this study is to inform the development of a large-scale RCT in relation to acceptability and attendance rates and to identify preliminary evidence for the interventions' clinical efficacy and potential underlying mechanisms. DESIGN Forty-five adults who are either overweight or obese (minimum body mass index of 25 kg/m2) will be randomly allocated to receive eight sessions over eight weeks of either computerised ABMT or MT or be on a waiting list. Clinical and cognitive outcomes will be assessed at baseline, post-treatment (8 weeks) and follow-up (12 weeks post-randomisation). These include mood, body composition and attention biases. Credibility and acceptability of the trainings will be assessed using questionnaires, and recruitment and retention rates will be recorded. DISCUSSION Findings will inform the feasibility of developing a large-scale RCT that takes into consideration effect sizes for primary outcome measures and the acceptability of the design. The study will also provide preliminary evidence on the clinical efficacy of two different attention trainings for people with obesity and associated underlying mechanisms. TRIAL REGISTRATION ISRCTN Registry, ISRCTN15745838. Registered on 22 May 2018.

中文翻译:

与食物相关的计算机注意力训练与正念训练以及超重或肥胖成年人的等待名单控制的随机对照可行性研究的研究方案。

背景技术肥胖症是高度流行的疾病,具有多种不利的健康后果。广泛可用的肥胖一线疗法,例如饮食和其他生活方式干预措施,通常仅具有短期作用。因此,需要新的治疗方法。诸如注意偏倚调整训练(ABMT)和基于正念的干预等新颖的干预措施,着重于改变肥胖者通常存在的不同适应不良的认知模式(例如,对食物线索的注意力偏向);但是,它们的作用机理仍然未知。我们描述了一项可行性随机对照试验(RCT)研究方案的理论基础和理论基础,该方案比较了超重或肥胖人群中的两种注意力训练(ABMT与正念训练[MT])。本研究的目的是为大规模RCT的可接受性和出勤率提供信息,并为干预措施的临床疗效和潜在的潜在机制确定初步证据。设计将对45名超重或肥胖(最低体重指数为25 kg / m2)的成年人进行随机分配,使其在8周内接受计算机化ABMT或MT的八个疗程,或处于等待名单中。临床和认知结局将在基线,治疗后(8周)和随访(随机化后12周)进行评估。这些包括情绪,身体组成和注意力偏差。培训的可信度和可接受性将使用问卷进行评估,并记录招聘和保留率。讨论结果将为开发大规模RCT的可行性提供参考,该研究考虑了主要结果指标的效应大小和设计的可接受性。该研究还将为肥胖者及其相关潜在机制的两种不同注意力训练的临床疗效提供初步证据。试用注册ISRCTN注册中心,ISRCTN15745838。2018年5月22日注册。
更新日期:2020-01-11
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