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Intervention Study: Genetic Risk Communication and Wearables

Primary Purpose

Fitness Trackers, Sedentary Behavior, 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 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
  • Able to perform daily-living physical activity
  • Able to use English to communicate
  • Use a smartphone

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
  • cannot use English

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 and general lifestyle advice e-leaflet, which includes information about T2D, health impacts of T2D and lifestyle advice on 4 major risk markers of T2D (e.g., PA, diet, smoking, weight management) as recommended by the World Health Organization.

This intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet.

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 Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Step count (per day) will be objectively measured by the Fitbit tracker.
Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Calories Burn (kcal 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 used to calculate BMI (in kg/m²).
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 4-week 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 4-week 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 4-week 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 4-week post-intervention, and between baseline and 6-month follow-up
This outcome will be assessed using an assessment questionnaire.

Full Information

First Posted
April 27, 2021
Last Updated
July 21, 2021
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT04879758
Brief Title
Intervention Study: Genetic Risk Communication and Wearables
Official Title
The Effect of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Objectively Measured Behavioral Outcomes: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (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
This study aims to determine the effects of communicating genetic risk for type 2 diabetes (T2D) alone or in combination with goal setting and prompts from a wearable device on objectively measured physical activity (PA) and sedentary behavior (SB) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively measured PA and SB, and that such changes will be more likely to be sustained over 6-month follow-up. This study aims to recruit 150 healthy East Asian adults in Hong Kong. At baseline, participants will be invited to visit the research laboratory for measurement of a series of variables including height, body weight, blood pressure and grip strength. Participants will also be invited to complete a set of questionnaires to assess their self-reported PA and SB, fruit and vegetable consumption, smoking status and psychological variables. Blood samples will be collected to analyze key diabetes and cardiovascular disease biochemical markers as well as their estimated genetic risk of T2D. Each individual's unique genetic risk for T2D will be estimated on the basis of established genetic variants associated with T2D specifically for East Asians. Each participant will be asked to wear a Fitbit Charge 4 tracker, an objective activity monitoring device, throughout the entire trial. Participants will be randomly allocated into 3 groups: 1 control and 2 intervention groups. A control group will receive an e-leaflet containing general lifestyle advice for prevention of T2D. An intervention group will receive an estimated genetic risk of T2D, in addition to the e-leaflet. The other intervention group will have a Fitbit step goal set 10% higher than their baseline step count and use prompt functions of the Fitbit tracker, in addition to the genetic risk estimate and e-leaflet. Activity data from the Fitbit will be collected at 4-week post-intervention; information about lifestyle and psychological variables will be assessed through the questionnaires at both immediate and 4-week post-intervention. To determine the longer-term effect of the intervention, participants will be asked to visit the research laboratory 6 months after the intervention to repeat the same set of assessments as baseline, except the blood samples collected at 6-month follow-up are used only to analyze cardiometabolic risk profiles (not genetic risk). Activity levels will also be objectively measured using the Fitbit for 4 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fitness Trackers, Sedentary Behavior, Exercise, Genetic Predisposition to Disease, Type 2 Diabetes
Keywords
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
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will receive a Fitbit device and general lifestyle advice e-leaflet, which includes information about T2D, health impacts of T2D and lifestyle advice on 4 major risk markers of T2D (e.g., PA, diet, smoking, weight management) as recommended by the World Health Organization.
Arm Title
Intervention Group - Genetic Risk Estimate
Arm Type
Experimental
Arm Description
This intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet.
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
Other
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 Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Step count (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week post-intervention, 6-month follow-up
Title
Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week post-intervention, 6-month follow-up
Title
Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week post-intervention, 6-month follow-up
Title
Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week post-intervention, 6-month follow-up
Title
Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week post-intervention, 6-month follow-up
Title
Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Description
Calories Burn (kcal per day) will be objectively measured by the Fitbit tracker.
Time Frame
Baseline, 4-week 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 used to calculate BMI (in kg/m²).
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 4-week 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, 4-week post-intervention, 6-month follow-up
Title
Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 4-week 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, 4-week post-intervention, 6-month follow-up
Title
Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 4-week 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, 4-week post-intervention, 6-month follow-up
Title
Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 4-week 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, 4-week 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 Able to perform daily-living physical activity Able to use English to communicate Use a smartphone 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 cannot use English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngwon Kim
Phone
(+852)28315252
Email
youngwon.kim@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngwon Kim
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
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
Phone
(+852)28315252
Email
youngwon.kim@hku.hk

12. IPD Sharing Statement

Learn more about this trial

Intervention Study: Genetic Risk Communication and Wearables

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