Intervention Study: Genetic Risk Communication and Wearables

July 21, 2021 updated by: Dr. Kim, Youngwon, The University of Hong Kong

The Effect of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies On Objectively Measured Behavioral Outcomes: A Randomized Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Exercise Physiology Lab, The University of Hong Kong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
No Intervention: Control Group
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.
Experimental: Intervention Group - Genetic Risk Estimate
This intervention group will receive an estimated genetic risk of T2D in addition to the Fitbit and e-leaflet.
Genetic: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Step count (per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up
Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Sedentary Minutes (per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up
Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Lightly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up
Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Fairly Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up
Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Very Active Minutes (per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up
Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
Time Frame: Baseline, 4-week post-intervention, 6-month follow-up
Calories Burn (kcal per day) will be objectively measured by the Fitbit tracker.
Baseline, 4-week post-intervention, 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic blood pressure between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Systolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Baseline and 6-month follow-up
Changes in diastolic blood pressure between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Diastolic blood pressure (mm Hg) will be measured using the OMRON HEM-907 Digital Automatic Blood Pressure Monitor.
Baseline and 6-month follow-up
Changes in hand grip strength between baseline and 6-month follow-up
Time Frame: 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.
Baseline and 6-month follow-up
Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
Time Frame: 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 (%).
Baseline and 6-month follow-up
Changes in Total cholesterol between baseline and 6-month follow-up
Time Frame: 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).
Baseline and 6-month follow-up
Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
Time Frame: 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).
Baseline and 6-month follow-up
Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
Time Frame: 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).
Baseline and 6-month follow-up
Changes in Triglycerides between baseline and 6-month follow-up
Time Frame: 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).
Baseline and 6-month follow-up
Changes in body mass index (BMI) between baseline and 6-month follow-up
Time Frame: Baseline and 6-month follow-up
Measured height (in meters) and body weight (in kilograms) will be used to calculate BMI (in kg/m²).
Baseline and 6-month follow-up
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
Time Frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
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
Time Frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
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
Time Frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
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
Time Frame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
This outcome will be assessed using an assessment questionnaire.
Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Youngwon Kim, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • geneticriskwearabletrial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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