Bailey Daniel P, Edwardson Charlotte L, Pappas Yannis, Dong Feng, Hewson David J, Biddle Stuart J H, Brierley Marsha L, Chater Angel M
Sedentary Behaviour, Health and Disease Research Group, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK.
Division of Sport, Health and Exercise Sciences, Department of Life Sciences, Brunel University London, Kingston Lane, Uxbridge, UB8 3PH, UK.
Pilot Feasibility Stud. 2021 Mar 19;7(1):76. doi: 10.1186/s40814-021-00816-0.
People with type 2 diabetes mellitus (T2DM) generally spend a large amount of time sitting. This increases their risk of cardiovascular disease, premature mortality, diabetes-related complications and mental health problems. There is a paucity of research that has evaluated interventions aimed at reducing and breaking up sitting in people with T2DM. The primary aim of this study is to assess the feasibility of delivering and evaluating a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM.
This is a mixed-methods randomised controlled feasibility trial. Participants (n=70) with T2DM aged 18-85 years who sit ≥7 h/day and are able to ambulate independently will be randomly allocated to receive the REgulate your SItting Time (RESIT) intervention or usual care (control group) for 24 weeks. RESIT is a person-focused intervention that delivers a standardised set of behaviour change techniques to the participants, but the mode through which they are delivered can vary depending on the tools selected by each participant. The intervention includes an online education programme, health coach support, and a range of self-selected tools (smartphone apps, computer-prompt software, and wearable devices) that deliver behaviour change techniques such as self-monitoring of sitting and providing prompts to break up sitting. Measures will be taken at baseline, 12 and 24 weeks. Eligibility, recruitment, retention and data completion rates will be used to assess trial feasibility. Sitting, standing and stepping will be measured using a thigh-worn activity monitor. Cardiometabolic health, physical function, psychological well-being, sleep and musculoskeletal symptoms will also be assessed. A process evaluation will be conducted including evaluation of intervention acceptability and fidelity.
This study will identify the feasibility of delivering a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM and evaluating it through a randomised controlled trial (RCT) design. The findings will inform a fully powered RCT to evaluate the effectiveness of the intervention.
ISRCTN, ISRCTN14832389 ; Registered 6 August 2020.
2型糖尿病（T2DM）患者通常长时间久坐。这增加了他们患心血管疾病、过早死亡、糖尿病相关并发症和心理健康问题的风险。针对减少和打破T2DM患者久坐行为的干预措施的研究较少。本研究的主要目的是评估为门诊T2DM成年患者提供并评估一种量身定制的减少和打破久坐行为干预措施的可行性。
这是一项混合方法的随机对照可行性试验。年龄在18 - 85岁、每天久坐≥7小时且能够独立行走的T2DM参与者（n = 70）将被随机分配接受调节久坐时间（RESIT）干预或常规护理（对照组），为期24周。RESIT是一种以个人为中心的干预措施，为参与者提供一套标准化的行为改变技巧，但其实施方式可根据每个参与者选择的工具而有所不同。干预措施包括在线教育项目、健康教练支持以及一系列自我选择的工具（智能手机应用程序、计算机提示软件和可穿戴设备），这些工具可提供行为改变技巧，如自我监测久坐情况并提供打破久坐的提示。将在基线、12周和24周时进行测量。将使用合格性、招募、留存和数据完成率来评估试验可行性。将使用佩戴在大腿上的活动监测器测量久坐、站立和行走情况。还将评估心脏代谢健康、身体功能、心理健康、睡眠和肌肉骨骼症状。将进行过程评估，包括评估干预措施的可接受性和保真度。
本研究将确定为门诊T2DM成年患者提供量身定制的减少和打破久坐行为干预措施并通过随机对照试验（RCT）设计对其进行评估的可行性。研究结果将为评估该干预措施有效性的充分有力的RCT提供参考。
ISRCTN，ISRCTN14832389；2020年8月6日注册。
