使用移动健康干预措施减少 2 型糖尿病患者职业性久坐行为的健康影响：一项为期 12 个月的随机对照试验研究方案——ROSEBUD 研究。

Health effects of reduced occupational sedentary behaviour in type 2 diabetes using a mobile health intervention: a study protocol for a 12-month randomized controlled trial-the ROSEBUD study.

机构信息

Department of Public Health and Clinical Medicine, Family Medicine, Umeå University, Umeå, Sweden.

Department of Clinical Sciences, Lund University, Malmö, Sweden.

出版信息

Trials. 2022 Jul 27;23(1):607. doi: 10.1186/s13063-022-06528-x.

DOI:10.1186/s13063-022-06528-x

PMID:35897022

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9331801/

Abstract

BACKGROUND

Short-term trials conducted in adults with type 2 diabetes mellitus (T2DM) showed that reducing sedentary behaviour by performing regular short bouts of light-intensity physical activity enhances health. Moreover, support for reducing sedentary behaviour may be provided at a low cost via mobile health technology (mHealth). There are a wide range of mHealth solutions available including SMS text message reminders and activity trackers that monitor the physical activity level and notify the user of prolonged sitting periods. The aim of this study is to evaluate the effects of a mHealth intervention on sedentary behaviour and physical activity and the associated changes in health in adults with T2DM.

METHODS

A dual-arm, 12-month, randomized controlled trial (RCT) will be conducted within a nationwide Swedish collaboration for diabetes research in primary health care. Individuals with T2DM (n = 142) and mainly sedentary work will be recruited across primary health care centres in five regions in Sweden. Participants will be randomized (1:1) into two groups. A mHealth intervention group who will receive an activity tracker wristband (Garmin Vivofit4), regular SMS text message reminders, and counselling with a diabetes specialist nurse, or a comparator group who will receive counselling with a diabetes specialist nurse only. The primary outcomes are device-measured total sitting time and total number of steps (activPAL3). The secondary outcomes are fatigue, health-related quality of life and musculoskeletal problems (self-reported questionnaires), number of sick leave days (diaries), diabetes medications (clinical record review) and cardiometabolic biomarkers including waist circumference, mean blood pressure, HbA1c, HDL-cholesterol and triglycerides.

DISCUSSION

Successful interventions to increase physical activity among those with T2DM have been costly and long-term effectiveness remains uncertain. The use of mHealth technologies such as activity trackers and SMS text reminders may increase awareness of prolonged sedentary behaviour and encourage increase in regular physical activity. mHealth may, therefore, provide a valuable and novel tool to improve health outcomes and clinical management in those with T2DM. This 12-month RCT will evaluate longer-term effects of a mHealth intervention suitable for real-world primary health care settings.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04219800 . Registered on 7 January 2020.

摘要

背景

在患有 2 型糖尿病（T2DM）的成年人中进行的短期试验表明，通过定期进行短暂的低强度体育活动来减少久坐行为可以增进健康。此外，通过移动健康技术（mHealth）可以以低成本提供对减少久坐行为的支持。mHealth 解决方案种类繁多，包括短信提醒和活动跟踪器，可监测活动水平并提醒用户长时间久坐。本研究旨在评估 mHealth 干预对 T2DM 成年人的久坐行为和身体活动以及相关健康变化的影响。

方法

这是一项在全国范围内进行的瑞典初级保健糖尿病研究合作中的双臂、12 个月、随机对照试验（RCT）。将从瑞典五个地区的初级保健中心招募久坐工作的 T2DM 个体（n=142）。参与者将被随机（1:1）分为两组。mHealth 干预组将接受活动跟踪器腕带（Garmin Vivofit4）、定期短信提醒和糖尿病专科护士咨询，对照组将仅接受糖尿病专科护士咨询。主要结局是设备测量的总坐时间和总步数（activPAL3）。次要结局是疲劳、健康相关生活质量和肌肉骨骼问题（自我报告问卷）、病假天数（日记）、糖尿病药物（临床记录审查）和心血管代谢生物标志物，包括腰围、平均血压、HbA1c、HDL-胆固醇和甘油三酯。

讨论

成功增加 T2DM 患者身体活动的干预措施成本高昂，长期效果仍不确定。使用 mHealth 技术，如活动跟踪器和短信提醒，可以提高对长时间久坐行为的认识，并鼓励增加有规律的身体活动。因此，mHealth 可能为改善 T2DM 患者的健康结果和临床管理提供有价值的新工具。这项为期 12 个月的 RCT 将评估适合真实世界初级保健环境的 mHealth 干预措施的长期效果。