Introduction: The communication of information about the risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviours among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with behavioural changes in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects of communicating genetic risk for T2D alone or in combination with wearable device functions on wearable device-measured PA among overweight or obese East Asians.

Methods and analysis: In a parallel group, randomised controlled trial, 355 overweight or obese East Asian individuals aged 40-60 years are allocated into one of three groups: one control and two intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 single-nucleotide polymorphisms associated with T2D among East Asians. All three groups receive a Fitbit device. Both intervention groups will receive T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups additionally uses Fitbit's step goal setting and prompt functions. Questionnaires and physical measurements are administered at baseline, immediately after intervention delivery, and 6 and 12 months post intervention. The primary outcome is time spent in moderate-to-vigorous PA from the Fitbit, which will be assessed at baseline, immediately post intervention, 12 months post intervention and at 6-month follow-up. Secondary outcomes include other wearable device-measured parameters, sedentary time, and sleep, blood pressure, metabolic risk markers, hand grip strength, self-reported PA, fruit and vegetable consumption, smoking, and psychological variables. Between-group differences in the continuous and categorical variables collected at baseline will be examined using Analysis of Variance (ANOVA) and χ² tests, respectively. A series of linear mixed effects models with fixed effects of time, group and interaction between time and group will be performed, with adjustment for potential confounders.

Ethics and dissemination: The study protocol has undergone review and received approval from the ethics committee of the University of Hong Kong. Findings from our trial will be disseminated through publication in peer-reviewed research journals and presented at international academic conferences.

Trial registration number: ClinicalTrials.gov, NCT05524909. https://register.

Clinicaltrials: gov/ (11 November 2024).

Keywords: Behavior; GENETICS; General diabetes; Protocols & guidelines; Randomized Controlled Trial.

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

简介： 单独传达关于2型糖尿病（T2D）风险的信息，并未与欧洲血统人群的日常行为改变相关联。相比之下，使用监测身体活动（PA）的可穿戴设备在某些研究中已被证明能够引起行为变化。目前尚不清楚风险沟通是否可以增强可穿戴设备的效果。我们旨在评估单独传达或结合可穿戴设备功能传达T2D遗传风险对超重或肥胖东亚人群通过可穿戴设备测量的身体活动量的影响。

方法与分析： 在一项平行组随机对照试验中，355名年龄为40至60岁的超重或肥胖东亚个体将被分配到三个组别之一：一个对照组和两个干预组。血液样本将用于估算T2D遗传风险并进行代谢风险标志物的分析。T2D遗传风险将以与东亚人群相关的113个单核苷酸多态性为基础进行估算。所有三组都将获得Fitbit设备。两组干预组都将获得T2D遗传风险评估及生活方式建议，但其中一个干预组还将使用Fitbit的步数目标设定和提示功能。在基线、干预完成后立即以及干预后的6个月和12个月将分发问卷并进行身体测量。主要结果指标是来自Fitbit的中等至高强度的身体活动时间，在基线、干预后立即、干预后的12个月及干预后的6个月随访时评估。次要结果指标包括其他通过可穿戴设备测量的参数，久坐时间，睡眠，血压，代谢风险标志物，握力，自我报告的身体活动量，水果和蔬菜摄入量，吸烟情况以及心理变量。将使用方差分析（ANOVA）和χ²检验分别对各组间在基线时收集的连续型和分类变量进行比较。将在调整潜在混淆因素后，通过固定效应为时间、组别及两者交互作用的一系列混合效应模型进行评估。

伦理与传播： 本研究方案已提交香港大学伦理委员会审查并通过批准。我们的试验结果将通过同行评审的研究期刊发表，并在国际学术会议上展示。

临床试验注册号： ClinicalTrials.gov, NCT05524909。https://register.

临床试验： gov/ (2024年11月11日)。