Intervention Study: Genetic Risk Communication and Wearables

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Fitness Trackers; Genetic Predisposition to Disease; Type 2 Diabetes; Exercise; Sedentary Behavior

Treatments: Other: Genetic Risk Estimate + Fitbit Functions; Genetic: Genetic Risk Estimate

Study type: Interventional

Funder types: Other

Identifiers

NCT04879758

geneticriskwearabletrial

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Control Group

No Intervention group

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.

Intervention Group - Genetic Risk Estimate

Experimental group

Description:

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

Treatment:

Genetic: Genetic Risk Estimate

Intervention Group - Genetic Risk Estimate + Fitbit Functions

Experimental group

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.

Treatment:

Other: Genetic Risk Estimate + Fitbit Functions