TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes
TECNOB: study design of a randomized controlled trial of a multidisciplinary telecare intervention for obese patients with type-2 diabetes
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DOI：
10.1186/1471-2458-10-204
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发表时间：
2010-04-23
影响因子：
4.5
通讯作者：
Molinari, Enrico
中科院分区：
文献类型：
--
作者：
Castelnuovo, Gianluca;Manzoni, Gian Mauro;Molinari, Enrico
背景：肥胖是我们这个时代最重要的医疗和公共卫生问题之一：它增加了许多健康并发症的风险，如高血压、冠心病和2型糖尿病，需要长期治疗才能取得有效效果，并涉及高昂的公共和私人成本。因此，开发和评估持久和低成本的肥胖及其相关并发症的临床计划是势在必行的。方法/设计：TECNOB(肥胖技术)是一个综合的两阶段逐步递减计划，通过远程医疗增强，用于寻求减肥干预的肥胖者的长期治疗。其核心特征是以医院为基础的强化治疗(1个月)，包括饮食治疗、身体训练和心理咨询，以及使用互联网和手机等新的信息和通信技术(ICT)在家中持续护理。TECNOB计划与常规治疗(仅基于医院的治疗)相比的有效性将在一项为期12个月的随机化对照试验(RCT)中进行评估。主要结果是体重(以公斤为单位)。次要结果指标是使用电子臂章测量的能量消耗、糖化血红蛋白、暴饮暴食、饮食自我效能和体重控制、身体满意度、健康习惯形成、与饮食紊乱相关的行为和认知、精神病理症状和与体重相关的生活质量。此外，这项研究将探索在我们考虑的那些人中，哪些行为和心理变量可以预测治疗成功。讨论：TECNOB研究旨在提供循证知识，了解远程医疗如何提高减肥和相关2型糖尿病临床干预的有效性，以及哪种类型的肥胖患者可能从此类干预中受益最大。总的来说，这项研究的目的还在于对传统医疗保健服务背后的理论模型产生影响，支持改变一种新的“无处不在的医疗保健”方法。
Background: Obesity is one of the most important medical and public health problems of our time: it increases the risk of many health complications such as hypertension, coronary heart disease and type 2 diabetes, needs long-lasting treatment for effective results and involves high public and private costs. Therefore, it is imperative that enduring and low-cost clinical programs for obesity and related co-morbidities are developed and evaluated.Methods/Design: TECNOB (TEChnology for OBesity) is a comprehensive two-phase stepped down program enhanced by telemedicine for the long-term treatment of obese people with type 2 diabetes seeking intervention for weight loss. Its core features are the hospital-based intensive treatment (1-month), that consists of diet therapy, physical training and psychological counseling, and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12-month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated hemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviors and cognitions, psychopathological symptoms and weight-related quality of life. Furthermore, the study will explore what behavioral and psychological variables are predictive of treatment success among those we have considered.Discussion: The TECNOB study aims to inform the evidence-based knowledge of how telemedicine may enhance the effectiveness of clinical interventions for weight loss and related type-2 diabetes, and which type of obese patients may benefit the most from such interventions. Broadly, the study aims also to have a effect on the theoretical model behind the traditional health care service, in favor of a change towards a new "health care everywhere" approach.