The Effect of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Wearable-Device-Measured Behavioral Outcomes in East Asians: Analysis plan of a Randomized Controlled Trial (Preprint)

BACKGROUND Evidence suggests that the dissemination of type 2 diabetes (T2D) genetic risk alone has displayed limited effectiveness on facilitating behavioral changes amongst individuals of European descent. Although the usage of physical activity surveillance systems such as wearable devices, have been associated with changes in behavior, the effects of combining personalized precision medicine with wearable devices on T2D prevention remains unclear. This study aims to assess the novel effects of T2D genetic risk communication and wearable device functions on objectively measured physical activity (PA) time amongst overweight and obese East Asian individuals. OBJECTIVE There are two specific objectives in this study. To investigate 1) the effects of communicating T2D genetic risk, and 2) 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 within overweight and obese East Asians. METHODS The study is conducted as a parallel group, randomized controlled trial. 355 overweight or obese East Asians aged between 40 to 60, are allocated into one of three groups: 1 control and 2 intervention groups. All participants are instructed to wear a Fitbit device throughout the study. Blood samples are used for estimation of T2D genetic risk and tested for metabolic risk markers. T2D genetic risk is estimated based on 113 SNPs associated with T2D in East Asians using an established method. Both intervention groups are provided with T2D genetic risk reports together with lifestyle advice leaflets on a weekly basis using whatsapp and on a monthly basis using email. Additional Fitbit wearable functions such as step-goal setting and prompt functions have been activated in one of the intervention groups. The primary outcome is moderate-to-vigorous physical activity (MVPA) time, which is objectively measured with the in-built accelerometer of the Fitbit Inspire 3 and will be assessed at baseline, immediately post-intervention, 12-months post intervention and post follow up. Secondary outcomes include other parameters measured by the wearable device, such as sedentary time, body mass index, systolic and diastolic blood pressure, five metabolic risk markers, hand grip strength, sleep, self-reported PA, self-reported fruit and vegetable consumption, smoking status and other psychological variables. RESULTS The intervention started in May 2023 and will continue until February 2024. CONCLUSIONS This study will be the first randomized controlled trial using a combination of T2D genetic risk communication with wearable device functions in any population. Novel findings will be used to inform future lifestyle modification strategies for T2D prevention. We plan to provide a comprehensive report on this study by publishing this analysis plan before the completion of data collection. CLINICALTRIAL ClinicalTrials.gov, NCT05524909. https://register.clinicaltrials.gov/ (30 Aug 2022)