Full-scale Intervention Study: Genetic Risk Communication and Wearables

NCT ID: NCT05524909

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 355 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2025-06-30

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.

Conditions

Fitness Trackers; Physical Activity; Exercise; Genetic Predisposition to Disease; Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control Group

The control group will receive a Fitbit device

Group Type: NO_INTERVENTION

No interventions assigned to this group

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 .

Group Type: EXPERIMENTAL

Genetic Risk Estimate

Intervention Type: GENETIC

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).

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.

Group Type: EXPERIMENTAL

Genetic Risk Estimate + Fitbit Functions

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: GENETIC

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kim, Youngwon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Exercise Physiology Lab, The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

References

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.

Reference Type: DERIVED

PMID: 39632119 (View on PubMed)

Other Identifiers

geneticriskwearabletrial_full

Identifier Type: -

Identifier Source: org_study_id