Clinical trial NCT05524909: Full-scale Intervention Study: Genetic Risk Communication and Wearables
Official title: Combined Effects of Communicating Genetic Risk of Type 2 Diabetes and Wearable Technologies on Objectively Measured Behavioral Outcomes in Overweight or Obese East Asian Individuals.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fitness Trackers
Physical Activity
Exercise
Genetic Predisposition to Disease
Type 2 Diabetes
Keywords: type 2 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: 2022-09-01
Enrollment: 355
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: Background: Communication of information about risk of type 2 diabetes (T2D) alone has not been associated with changes in habitual behaviors among individuals of European ancestry. In contrast, the use of wearable devices that monitor physical activity (PA) has been associated with changes in behavior in some studies. It is uncertain whether risk communication might enhance the effects of wearable devices. We aim to assess the effects on wearable-device-measured PA of communicating genetic risk for T2D alone or in combination with goal setting and activity prompts from a wearable device among overweight or obese East Asians.

Methods: In a parallel group, randomized controlled trial, a total of 355 overweight or obese East Asian individuals aged 40-60 years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of T2D genetic risk and analysis of metabolic risk markers. Genetic risk of T2D will be estimated based on 113 SNPs associated with T2D among East Asians using an established method. All three groups will receive a Fitbit device. Both intervention groups will be given T2D genetic risk estimates along with lifestyle advice, but one of the intervention groups will additionally use Fitbit's step-goal setting and prompt functions. Questionnaires and physical measurements will be administered at baseline, immediately after intervention delivery, and 6 and 12-month post-intervention following standard operating procedures. The primary outcome is time spent in moderate-to-vigorous PA measured through the Fitbit. Secondary outcomes include other parameters of wearable-device-measured PA, sedentary time, and sleep, body mass index, systolic and diastolic blood pressure, five intermediate metabolic risk markers, hand grip strength, self-reported PA, self-reported fruit and vegetable consumption and smoking status, and a list of psychological variables.

Discussion: This study will be the first randomized controlled trial using the combination of communication of T2D genetic risk with standard functions of wearable devices in any population. Findings will inform strategies to prevent T2D through lifestyle modification.


Eligibility criteria: Inclusion Criteria:

* East Asian ancestry
* Aged 40-60 years
* overweight or obese (i.e. measured BMI ≥23 kilograms/meters2 according to the WHO BMI-defined cut-offs for Asians)
* Able to perform daily-living physical activity
* using English/Chinese and a smartphone in Hong Kong

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
* and/or cannot comprehend English/Chinese (i.e., sole language medium for the study).

Primary outcomes:
measure: Changes in Moderate to Vigorous Physical Activity Minutes between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, 12-month 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 12-month post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: Changes in Self-reported Fruit and Vegetable Consumption between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: Changes in Self-reported Smoking Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: Changes in Self-reported Psychological Status between baseline and Immediate post-intervention, between baseline and 12-month post-intervention, and between baseline and 6-month follow-up
timeFrame: Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up
measure: Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)
timeFrame: Baseline, 12-month 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:
References: