Intervention Study: Genetic Risk Communication and Wearables

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879758
• Other study ID #: geneticriskwearabletrial
• Status: Recruiting
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: May 2024

Study information

• Verified date: July 2021
• Source: The University of Hong Kong
• Contact: Youngwon Kim
• Phone: (+852)28315252
• Email: youngwon.kim[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Disease Susceptibility
• Exercise
• Fitness Trackers
• Genetic Predisposition to Disease
• Sedentary Behavior
• Type 2 Diabetes

Intervention

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).

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.

Locations

Country	Name	City	State
Hong Kong	Exercise Physiology Lab, The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Primary	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.	Baseline, 4-week post-intervention, 6-month follow-up
Secondary	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).	Baseline and 6-month follow-up
Secondary	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.	Baseline and 6-month follow-up
Secondary	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.	Baseline and 6-month follow-up
Secondary	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.	Baseline and 6-month follow-up
Secondary	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 (%).	Baseline and 6-month follow-up
Secondary	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).	Baseline and 6-month follow-up
Secondary	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).	Baseline and 6-month follow-up
Secondary	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).	Baseline and 6-month follow-up
Secondary	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).	Baseline and 6-month follow-up
Secondary	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.	Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Secondary	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.	Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Secondary	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.	Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Secondary	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.	Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up