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The Regulate your Sitting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: findings from a randomised-controlled feasibility trial
Diabetology & Metabolic Syndrome ( IF 4.8 ) Pub Date : 2024-04-24 , DOI: 10.1186/s13098-024-01336-6
Marsha L. Brierley , Angel M. Chater , Charlotte L. Edwardson , Ellen M. Castle , Emily R. Hunt , Stuart JH. Biddle , Rupa Sisodia , Daniel P. Bailey

Reducing and breaking up sitting is recommended for optimal management of Type 2 diabetes mellitus (T2DM). Yet, there is limited evidence of interventions targeting these outcomes in individuals with this condition. The primary aim of this study was to assess the feasibility and acceptability of delivering and evaluating a tailored online intervention to reduce and break up sitting in adults with T2DM. A mixed-methods two-arm randomised controlled feasibility trial was conducted in ambulatory adults with T2DM who were randomised 1:1 to the REgulate your SItting Time (RESIT) intervention or usual care control group. The intervention included online education, self-monitoring and prompt tools (wearable devices, smartphone apps, computer apps) and health coaching. Feasibility outcomes were recruitment, attrition, data completion rates and intervention acceptability. Measurements of device-assessed sitting (intended primary outcome for definitive trial), standing and stepping, and physical function, psychosocial health and wellbeing were taken at baseline, 3 months and 6 months. Individual semi-structured interviews were conducted at six-months (post intervention) to explore acceptability, feasibility and experiences of the trial and intervention using the Framework Method. Seventy participants aged 55 ± 11 years were recruited. Recruitment rate (proportion of eligible participants enrolled into the study) was 67% and participant retention rate at 6 months was 93% (n = 5 withdrawals). Data completion rates for daily sitting were 100% at baseline and ranged from 83 to 91% at 3 months and 6 months. Descriptive analysis demonstrated potential for the intervention to reduce device-measured sitting, which was 30.9 ± 87.2 and 22.2 ± 82.5 min/day lower in the intervention group at 3 and 6 months, respectively, compared with baseline. In the control group, sitting was 4.4 ± 99.5 and 23.7 ± 85.2 min/day lower at 3 and 6 months, respectively. Qualitative analysis identified three themes: reasons for participating in the trial, acceptability of study procedures, and the delivery and experience of taking part in the RESIT intervention. Overall, the measurement visits and intervention were acceptable to participants. This study demonstrated the feasibility and acceptability of the RESIT intervention and evaluation methods, supporting a future definitive trial. If RESIT is found to be clinically effective, this could lead to changes in diabetes healthcare with a focus on reducing sitting. The trial was registered with ISRCTN (number ISRCTN14832389).

中文翻译:

用于减少 2 型糖尿病患者坐姿时间的调节坐姿时间 (RESIT) 干预措施:随机对照可行性试验的结果

建议减少和打破久坐的习惯,以实现 2 型糖尿病 (T2DM) 的最佳管理。然而,针对患有这种疾病的个体的这些结果的干预措施的证据有限。本研究的主要目的是评估提供和评估量身定制的在线干预措施的可行性和可接受性,以减少和打破 T2DM 成人久坐的习惯。在患有 T2DM 的门诊成人中进行了一项混合方法双臂随机对照可行性试验,他们按 1:1 随机分配到调整坐姿时间 (RESIT) 干预组或常规护理对照组。干预措施包括在线教育、自我监控和提示工具(可穿戴设备、智能手机应用程序、计算机应用程序)以及健康指导。可行性结果包括招募、人员流失、数据完成率和干预可接受性。在基线、3 个月和 6 个月时对设备评估的坐姿(最终试验的预期主要结果)、站立和迈步以及身体功能、心理社会健康和幸福感进行测量。在六个月(干预后)进行个人半结构化访谈,以探讨使用框架方法进行试验和干预的可接受性、可行性和经验。招募了 70 名年龄在 55 ± 11 岁的参与者。招募率(参与研究的合格参与者的比例)为 67%,6 个月时的参与者保留率为 93%(n = 5 例退出)。每日坐姿的数据完成率在基线时为 100%,在 3 个月和 6 个月时为 83% 至 91%。描述性分析表明,干预措施有可能减少设备测量的坐姿,与基线相比,干预组在 3 个月和 6 个月时分别减少了 30.9 ± 87.2 分钟/天和 22.2 ± 82.5 分钟/天。在对照组中,第 3 个月和第 6 个月时,每天坐的时间分别减少了 4.4 ± 99.5 分钟和 23.7 ± 85.2 分钟。定性分析确定了三个主题:参与试验的原因、研究程序的可接受性以及参与 RESIT 干预的实施和体验。总体而言,参与者可以接受测量访问和干预。本研究证明了 RESIT 干预和评估方法的可行性和可接受性,为未来的最终试验提供支持。如果发现 RESIT 在临床上有效,这可能会导致糖尿病医疗保健发生变化,重点是减少久坐。该试验已在 ISRCTN 注册(编号 ISRCTN14832389)。
更新日期:2024-04-24
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