Full-scale Intervention Study: Genetic Risk Communication and Wearables
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.
1 other identifier
interventional
355
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedMay 4, 2026
November 1, 2025
2.5 years
August 30, 2022
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline, 12-month post-intervention, 6-month follow-up
Secondary Outcomes (14)
Changes in body mass index (BMI) between baseline and 6-month follow-up
Baseline and 6-month follow-up
Changes in systolic blood pressure between baseline and 6-month follow-up
Baseline and 6-month follow-up
Changes in diastolic blood pressure between baseline and 6-month follow-up
Baseline and 6-month follow-up
Changes in hand grip strength between baseline and 6-month follow-up
Baseline and 6-month follow-up
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Baseline and 6-month follow-up
- +9 more secondary outcomes
Study Arms (3)
Control Group
NO INTERVENTIONThe control group will receive a Fitbit device
Intervention Group - Genetic Risk Estimate
EXPERIMENTALThis intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .
Intervention Group - Genetic Risk Estimate + Fitbit Functions
EXPERIMENTALThis 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Exercise Physiology Lab, The University of Hong Kong
Hong Kong, Hong Kong
Related Publications (2)
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.
PMID: 41191904DERIVEDKim 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.
PMID: 39632119DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (for preparation of corresponding e-leaflets, genetic risk estimates and/or baseline Fitbit step goal calculations), and from participants until the interventions are delivered. Given the nature of the interventions delivered, it will be impossible for participants to be blinded to the specific intervention they receive once the initial interventions are provided; however, study staff analyzing participants' de-identified data will remain blinded to participant randomization assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 30, 2022
First Posted
September 1, 2022
Study Start
November 1, 2022
Primary Completion
April 30, 2025
Study Completion
June 30, 2025
Last Updated
May 4, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- The datasets analysed during the current study and statistical code will be available after the completion of the study
- Access Criteria
- IPD data can be accessed based on reasonable request by contacting the corresponding author.
The datasets analysed during the current study and statistical code are available from the corresponding author on reasonable request, as is the full protocol.