Full-scale Intervention Study: Genetic Risk Communication and Wearables

April 28, 2026 updated by: Dr. Kim, Youngwon, The University of Hong Kong

Combined Effects of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Objectively Measured Behavioral Outcomes in Overweight or Obese East Asian Individuals.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

355

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Exercise Physiology Lab, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • East Asian ancestry
  • Aged 40-60 years
  • overweight or obese (i.e. measured BMI ≥23 kilograms/meters2 according to the WHO BMI-defined cut-offs for Asians)
  • Able to perform daily-living physical activity
  • using English/Chinese and a smartphone in Hong Kong

Exclusion Criteria:

  • have been diagnosed with any type of diabetes
  • pregnant or lactating
  • unable to perform daily-life physical activities (determined through Physical activity Readiness Questionnaire [PAR-Q])
  • participating in another research study or exercise programs
  • had experience of genetic testing
  • and/or cannot comprehend English/Chinese (i.e., sole language medium for the study).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The control group will receive a Fitbit device
Experimental: Intervention Group - Genetic Risk Estimate
This intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .
Genetic: Genetic Risk Estimate
The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).
Experimental: Intervention Group - Genetic Risk Estimate + Fitbit Functions
This intervention group will receive a Fitbit device, but have a Fitbit step goal set 10% higher than their baseline step count, and use its prompt functions, in addition to the genetic risk estimate and e-leaflet.
Device: Genetic Risk Estimate + Fitbit Functions

The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).

The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Moderate to Vigorous Physical Activity Minutes between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 12-month post-intervention, 6-month follow-up
Moderate to Vigorous Physical Activity Minutes (per day) will be objectively measured by the Fitbit tracker.
Baseline, 12-month post-intervention, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in body mass index (BMI) between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Measured height (in meters) and body weight (in kilograms) will be combined to report BMI in kg/m^2
Baseline and 6-month follow-up
Changes in systolic blood pressure between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Systolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Baseline and 6-month follow-up
Changes in diastolic blood pressure between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Diastolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Baseline and 6-month follow-up
Changes in hand grip strength between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Hand grip strength (in kilograms) will be measured using the Jamar Hydraulic Hand Dynamometer, which has good reliability and reproducibility.
Baseline and 6-month follow-up
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HbA1c (%).
Baseline and 6-month follow-up
Changes in Total cholesterol between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Total cholesterol (mmol/L).
Baseline and 6-month follow-up
Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HDL (mmol/L).
Baseline and 6-month follow-up
Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including LDL (mmol/L).
Baseline and 6-month follow-up
Changes in Triglycerides between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Triglycerides (mmol/L).
Baseline and 6-month follow-up
Changes in Self-reported Physical Activity between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
Time Frame: Baseline, 12-month post-intervention, 6-month follow-up
steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.
Baseline, 12-month post-intervention, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

August 30, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • geneticriskwearabletrial_full

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets analysed during the current study and statistical code are available from the corresponding author on reasonable request, as is the full protocol.

IPD Sharing Time Frame

The datasets analysed during the current study and statistical code will be available after the completion of the study

IPD Sharing Access Criteria

IPD data can be accessed based on reasonable request by contacting the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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