Effects of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies on Behavioral Outcomes in East Asians: Statistical Analysis Protocol for a Randomized Controlled Trial.

backgroundEvidence suggests that the communication of type 2 diabetes (T2D) genetic risk alone has limited effectiveness on facilitating behavioral changes among individuals of European descent. Although the use of wearable devices has been associated with changes in behavior, the effects of combining personalized precision medicine with wearable devices on behaviors related to T2D prevention remain unclear. This study aims to assess the novel effects of T2D genetic risk communication and wearable device functions on objectively measured moderate to vigorous physical activity (MVPA) time among East Asian individuals with overweight or obesity.

objectiveThe objectives of this study are to (1) investigate the effects of communicating T2D genetic risk and (2) examine the effects of combining T2D genetic risk communication with wearable device functions such as step goal setting and activity prompts on objectively measured MVPA time among East Asians with overweight or obesity.

methodsIn this parallel-group randomized controlled trial, 355 East Asians with overweight or obesity aged between 40 and 60 years are allocated to 1 of 3 groups: 1 control and 2 intervention groups. Blood samples are used for estimation of T2D genetic risk and tested for metabolic risk markers. T2D genetic risk is estimated based on 113 single nucleotide polymorphisms associated with T2D among East Asians using an established method. All 3 groups receive a Fitbit device. Both intervention groups will receive T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will receive additional Fitbit functions: step goal setting and prompt functions. The intervention materials are delivered weekly using WhatsApp and monthly via email. The primary outcome is MVPA time, which is objectively measured with the built-in accelerometer of the Fitbit Inspire 3 and will be assessed at baseline, immediately after the intervention, 12 months after the intervention, and at 6-month follow-up. Secondary outcomes include other parameters, such as sedentary time, BMI, systolic and diastolic blood pressure, 5 metabolic risk markers, handgrip strength, sleep, activity calories, self-reported physical activity, self-reported fruit and vegetable consumption, smoking status, and psychological variables.

resultsThis study was funded in January 2023. Data collection for baseline assessments began in February 2023. Formal data analysis started in April 2025 after the 6-month follow-up assessments were completed.

conclusionsTo the best of our knowledge, this study will be the first randomized controlled trial to combine T2D genetic risk communication with wearable device functions in any population. Novel findings will be used to inform future lifestyle modification strategies for T2D. We plan to provide a comprehensive report on this study by publishing this analysis plan before the completion of data collection.

trial registrationClinicalTrials.gov NCT05524909; https://www.clinicaltrials.gov/study/NCT05524909. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65012.