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Full-scale Intervention Study: Genetic Risk Communication and Wearables

Primary Purpose

Fitness Trackers, Physical Activity, Exercise

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Genetic Risk Estimate
Genetic Risk Estimate + Fitbit Functions
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fitness Trackers focused on measuring type 2 diabetes, physical activity, genetic risk, wearable technology, randomized controlled trial, movement behavior, nutrition

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

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

Sites / Locations

  • Exercise Physiology Lab, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control Group

Intervention Group - Genetic Risk Estimate

Intervention Group - Genetic Risk Estimate + Fitbit Functions

Arm Description

The control group will receive a Fitbit device

This intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.
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 (%).
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).
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).
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).
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).
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.
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.
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.
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.
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.

Full Information

First Posted
August 30, 2022
Last Updated
May 11, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05524909
Brief Title
Full-scale Intervention Study: Genetic Risk Communication and Wearables
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fitness Trackers, Physical Activity, Exercise, Genetic Predisposition to Disease, Type 2 Diabetes
Keywords
type 2 diabetes, physical activity, genetic risk, wearable technology, randomized controlled trial, movement behavior, nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel-group, open randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
355 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive a Fitbit device
Arm Title
Intervention Group - Genetic Risk Estimate
Arm Type
Experimental
Arm Description
This intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .
Arm Title
Intervention Group - Genetic Risk Estimate + Fitbit Functions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Genetic
Intervention Name(s)
Genetic Risk Estimate
Intervention Description
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
Device
Intervention Name(s)
Genetic Risk Estimate + Fitbit Functions
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Moderate to Vigorous Physical Activity Minutes (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 12-month post-intervention, 6-month follow-up
Secondary Outcome Measure Information:
Title
Changes in body mass index (BMI) between baseline and 6-month follow-up
Description
Measured height (in meters) and body weight (in kilograms) will be combined to report BMI in kg/m^2
Time Frame
Baseline and 6-month follow-up
Title
Changes in systolic blood pressure between baseline and 6-month follow-up
Description
Systolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Time Frame
Baseline and 6-month follow-up
Title
Changes in diastolic blood pressure between baseline and 6-month follow-up
Description
Diastolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Time Frame
Baseline and 6-month follow-up
Title
Changes in hand grip strength between baseline and 6-month follow-up
Description
Hand grip strength (in kilograms) will be measured using the Jamar Hydraulic Hand Dynamometer, which has good reliability and reproducibility.
Time Frame
Baseline and 6-month follow-up
Title
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Description
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HbA1c (%).
Time Frame
Baseline and 6-month follow-up
Title
Changes in Total cholesterol between baseline and 6-month follow-up
Description
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Total cholesterol (mmol/L).
Time Frame
Baseline and 6-month follow-up
Title
Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
Description
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including HDL (mmol/L).
Time Frame
Baseline and 6-month follow-up
Title
Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
Description
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including LDL (mmol/L).
Time Frame
Baseline and 6-month follow-up
Title
Changes in Triglycerides between baseline and 6-month follow-up
Description
Blood samples will be collected to test the five key biochemical markers of T2D and cardiovascular disease, including Triglycerides (mmol/L).
Time Frame
Baseline and 6-month follow-up
Title
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
Description
This outcome will be assessed using an assessment questionnaire.
Time Frame
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Title
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
Description
This outcome will be assessed using an assessment questionnaire.
Time Frame
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Title
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
Description
This outcome will be assessed using an assessment questionnaire.
Time Frame
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Title
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
Description
This outcome will be assessed using an assessment questionnaire.
Time Frame
Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
Title
Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
Description
steps, sedentary minutes, lightly active minutes, calories burn, and sleep time will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 12-month post-intervention, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngwon Kim, Dr
Phone
(+852)28315252
Email
youngwon.kim@hku.hk
Facility Information:
Facility Name
Exercise Physiology Lab, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngwon Kim, Dr
Phone
(+852)28315252
Email
youngwon.kim@hku.hk

12. IPD Sharing Statement

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Full-scale Intervention Study: Genetic Risk Communication and Wearables

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