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Fitness TrackersNCT05524909

Full-scale Intervention Study: Genetic Risk Communication and Wearables

A study testing Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions in people with Fitness Trackers and Physical Activity, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Fitness Trackers, Physical Activity, Exercise
What is being tested?
Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
355 participants
Where
1 siteHong Kong
Study dates
1 Nov 2022to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Exercise Physiology Lab, The University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Being tested
Genetic Risk Estimate, Genetic Risk Estimate + Fitbit Functions
Keywords
type 2 diabetes, physical activity, genetic risk, wearable technology, randomized controlled trial, movement behavior, nutrition
Medical subject headings
Motor Activity, Genetic Predisposition to Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Genetic Risk EstimateGenetic

    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).

  • Genetic Risk Estimate + Fitbit FunctionsDevice

    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.

Study groups in NCT05524909
Study groupRoleWhat they receive
Control GroupNo interventionThe control group will receive a Fitbit device
Intervention Group - Genetic Risk EstimateExperimentalThis intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .
Receives: Genetic: Genetic Risk Estimate
Intervention Group - Genetic Risk Estimate + Fitbit FunctionsExperimentalThis 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.
Receives: Device: Genetic Risk Estimate + Fitbit Functions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Moderate to Vigorous Physical Activity Minutes (per day) will be objectively measured by the Fitbit tracker.

    Measured: Baseline, 12-month post-intervention, 6-month follow-up

Secondary outcomes (14)

  1. Changes in body mass index (BMI) between 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

    Measured: Baseline and 6-month follow-up

  2. Changes in systolic blood pressure between baseline and 6-month follow-up

    Systolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.

    Measured: Baseline and 6-month follow-up

  3. Changes in diastolic blood pressure between baseline and 6-month follow-up

    Diastolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.

    Measured: Baseline and 6-month follow-up

  4. Changes in hand grip strength between 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.

    Measured: Baseline and 6-month follow-up

  5. Changes in Hemoglobin A1c (HbA1c) between 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 (%).

    Measured: Baseline and 6-month follow-up

  6. Changes in Total cholesterol between 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).

    Measured: Baseline and 6-month follow-up

  7. Changes in High-density lipoproteins (HDL) between 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).

    Measured: Baseline and 6-month follow-up

  8. Changes in Low-density lipoproteins (LDL) between 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).

    Measured: Baseline and 6-month follow-up

  9. Changes in Triglycerides between 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).

    Measured: Baseline and 6-month follow-up

  10. 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

    This outcome will be assessed using an assessment questionnaire.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  11. 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

    This outcome will be assessed using an assessment questionnaire.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  12. 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

    This outcome will be assessed using an assessment questionnaire.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  13. 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

    This outcome will be assessed using an assessment questionnaire.

    Measured: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up

  14. Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)

    steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.

    Measured: Baseline, 12-month post-intervention, 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2022
  2. Study start1 Nov 2022
  3. Primary completion30 Apr 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
parallel-group, open randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
355 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05524909
Sponsor's protocol ID
geneticriskwearabletrial_full
Status last verified
Nov 2025
First submitted
30 Aug 2022
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets analysed during the current study and statistical code are available from the corresponding author on reasonable request, as is the full protocol.

Publications

  • Ho HHS, Chen Z, Godino J, Multhaup M, Chan DKC, Au Yeung SL, Luo S, Chung BHY, Griffin S, Kim Y. 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. JMIR Res Protoc. 2025 Nov 5;14:e65012. doi: 10.2196/65012.

    PubMed 41191904

  • Kim Y, Godino JG, Cheung FLT, Multhaup M, Chan DKCKC, Chen Z, Ho HHS, Tse THT, Au Yeung SLR, Lou S, Zhang JH, Wang M, Chung B, Griffin S. 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. BMJ Open. 2024 Dec 4;14(12):e082635. doi: 10.1136/bmjopen-2023-082635.

    PubMed 39632119

Questions about this trial

What is this clinical trial studying?

A study testing Genetic Risk Estimate and Genetic Risk Estimate + Fitbit Functions in people with Fitness Trackers and Physical Activity, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05524909, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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