NCT05524909

Full-scale Intervention Study: Genetic Risk Communication and Wearables

Active, enrolled NA Last updated 14 November 2024

What this trial tests

NA trial testing Genetic Risk Estimate in Fitness Trackers in 355 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2022

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	355
Start date	1 November 2022
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	1 location across Hong Kong

Drugs / interventions tested

• Genetic Risk Estimate
• Genetic Risk Estimate + Fitbit Functions

Conditions studied

• Fitness Trackers — all drugs for Fitness Trackers →
• Physical Activity — all drugs for Physical Activity →
• Exercise — all drugs for Exercise →
• Genetic Predisposition to Disease — all drugs for Genetic Predisposition to Disease →

Sponsor

The University of Hong Kong

Who can join

Adults 40 to 60, any sex, with Fitness Trackers or Physical Activity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 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 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables.

Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of communicating genetic risk of type 2 diabetes and wearable technologies on wearable device-measured behavioural outcomes in East Asians: protocol of a randomised controlled trial.
   Kim Y, Godino JG, Cheung FLT, Multhaup M, et al · · 2024 · cited 1× · PMID 39632119 · DOI 10.1136/bmjopen-2023-082635
2. 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.
   Ho HHS, Chen Z, Godino J, Multhaup M, et al · · 2025 · PMID 41191904 · DOI 10.2196/65012