Clinical trial NCT04879758: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, open randomized controlled trial
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Changes in Steps between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
measure: Changes in Sedentary Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
measure: Changes in Lightly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
measure: Changes in Fairly Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
measure: Changes in Very Active Minutes between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
measure: Changes in Calories Burn between baseline and 4-week post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 4-week post-intervention, 6-month follow-up
Secondary outcomes:
measure: Changes in body mass index (BMI) between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in systolic blood pressure between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in diastolic blood pressure between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in hand grip strength between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in Total cholesterol between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: Changes in Triglycerides between baseline and 6-month follow-up
timeFrame: Baseline and 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
measure: 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
timeFrame: Baseline, Immediate post-intervention, 4-week post-intervention, 6-month follow-up
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Exercise Physiology Lab, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Youngwon Kim
role: PRINCIPAL_INVESTIGATOR
References: