Ensenyat Assumpta, Espigares-Tribo Gemma, Machado Leonardo, Verdejo Francisco José, Rodriguez-Arregui Rosa, Serrano José, Miret Marta, Galindo Gisela, Blanco Alfonso, Marsal Josep-Ramon, Sarriegui Susana, Sinfreu-Bergues Xenia, Serra-Paya Noemi
Institut Nacional d'Educacio Fisica de Catalunya - Campus Lleida, Lleida, Catalonia, Spain.
BMC Public Health. 2017 Mar 14;17(1):257. doi: 10.1186/s12889-017-4144-8.
The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus).
METHODS/DESIGN: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group.
The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle.
Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered).
本研究的主要目的是评估不同剂量（强度）的有监督运动训练（同时进行生活方式咨询）作为一种初级保健干预工具，用于管理患有一种或多种此类因素的低活动水平成年人代谢综合征风险因素的有效性（加泰罗尼亚语项目名称：Bellugat de CAP a peus）。
方法/设计：在初级保健环境中实施的三臂随机对照临床试验，为期40周（16周干预和24周随访）。年龄在30至55岁之间患有代谢风险因素的成年人将被随机分为三个干预组：1）有氧间歇训练（16节有监督训练课程）加健康生活方式咨询计划（6次小组会议和3次个人会议）；2）低至中等强度持续训练（16节有监督训练课程）加相同的咨询计划；或3）仅咨询计划，无任何有监督的体育锻炼。评估的主要输出变量将是代谢综合征的风险因素（腰围、血压以及血浆甘油三酯、高密度脂蛋白和葡萄糖水平）、全身炎症、心肺适能、身体活动和久坐行为、饮食习惯、健康相关生活质量、自我效能感和赋权。还将分析经济因素以确定该计划的成本效益。这些变量将在研究期间进行三次评估：基线时、干预结束时和随访时。我们估计每组招募35名参与者。
本研究结果将深入了解有氧间歇训练和多学科行为干预相结合的方法对代谢风险和生活方式的即时和中期影响。如果有效，拟议的干预措施将为该领域的研究人员和从业者提供一个平台，用以制定类似的干预计划，以应对不健康生活方式的影响。
Clinical trials.gov。NTC02832453。2016年7月6日注册（追溯注册）。
