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一项评估基于投资的干预措施对减肥手术后体重减轻、信念和行为影响的随机对照试验:研究方案。

A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol.

作者信息

Hollywood Amelia, Ogden Jane, Hashemi Majid

机构信息

Department of Psychology, University of Surrey, Guildford, GU2 7XH UK.

University College London Hospital, GI Services, Ground Floor West, 250 Euston Road, London, NW1 2PG UK.

出版信息

BMC Obes. 2015 Mar 21;2:18. doi: 10.1186/s40608-015-0048-2. eCollection 2015.

Abstract

BACKGROUND

Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous research shows that successful weight loss may be associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them and a means to improve weight loss outcomes.

METHODS

The study involves an open randomised parallel group control trial with patients allocated either to the control or investment intervention group. Using third party blinded randomization, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery then 3 and 6 months after surgery. All patients will record their weight, beliefs about food, intentions to change and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. Patients will be recruited from the bariatric surgery pre-assessment clinic at University College Hospital, London. The primary outcome is to explore the impact of the investment based intervention on patient's weight and BMI, with secondary outcomes of patients' beliefs about foods, behavioural intentions and diet and exercise behaviours.

DISCUSSION

It is predicted that the investment intervention will improve excess weight loss post-surgery, together with beliefs about food, intentions to change and actual change in diet and exercise behaviour. This has cost implications for the NHS and other healthcare providers as improved effectiveness of bariatric surgery reduces the health costs of obese patients in the longer term and this simple, easy to administer and low cost intervention could become routine practice for bariatric patients.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT02045628; December 2, 2013.

摘要

背景

尽管肥胖症手术目前是实现体重减轻的最有效方法,但并非所有患者都能减轻预期的体重,有些患者还出现了体重反弹。先前的研究表明,成功减重可能与患者认为自己在手术中投入的程度有关。例如,那些觉得组织手术花费了更多时间和精力、花费了更多金钱、对生活造成了更大干扰并且带来了痛苦的患者,术后更有可能减重。因此,似乎投入感越强,使手术成功的动力就越大。本研究旨在基于这些发现,通过鼓励肥胖症手术患者关注他们所做的投入,从而使他们的投入对他们来说更加突出,并成为改善减重效果的一种方式。

方法

该研究为开放性随机平行组对照试验,患者被分配到对照组或投入干预组。采用第三方盲法随机化,一半患者将被要求在手术前、术后3个月和6个月对他们在手术中的投入进行评分并描述。所有患者将在基线时以及术后3个月、6个月和12个月记录他们的体重、对食物的看法、改变的意图以及实际的饮食和运动行为。患者将从伦敦大学学院医院的减肥手术预评估诊所招募。主要结果是探讨基于投入的干预对患者体重和体重指数的影响,次要结果是患者对食物的看法、行为意图以及饮食和运动行为。

讨论

预计投入干预将改善术后的超重减轻情况,以及对食物的看法、改变的意图以及饮食和运动行为的实际改变。这对英国国家医疗服务体系(NHS)和其他医疗服务提供者具有成本影响,因为减肥手术有效性的提高从长期来看会降低肥胖患者的医疗成本,而这种简单、易于实施且低成本的干预措施可能会成为减肥患者的常规做法。

试验注册

ClinicalTrials.gov标识符NCT02045628;2013年12月2日。

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