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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 355
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (for preparation of corresponding e-leaflets, genetic risk estimates and/or baseline Fitbit step goal calculations), and from participants until the interventions are delivered. Given the nature of the interventions delivered, it will be impossible for participants to be blinded to the specific intervention they receive once the initial interventions are provided; however, study staff analyzing participants' de-identified data will remain blinded to participant randomization assignment.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Control Group
The control group will receive a Fitbit device
Intervention Group - Genetic Risk Estimate
This intervention group will receive an estimated genetic risk and e-leaflet of type 2 diabetes in addition to the Fitbit .
干预措施: Genetic Risk Estimate (Genetic)
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.
干预措施: Genetic Risk Estimate + Fitbit Functions (Device)
结局指标
主要结局
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
时间窗: Baseline, 12-month post-intervention, 6-month follow-up
Moderate to Vigorous Physical Activity Minutes (per day) will be objectively measured by the Fitbit tracker.
次要结局
- Changes in diastolic blood pressure between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in body mass index (BMI) between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in systolic blood pressure between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in hand grip strength between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in Triglycerides between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in Hemoglobin A1c (HbA1c) between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in Total cholesterol between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in High-density lipoproteins (HDL) between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- Changes in Low-density lipoproteins (LDL) between baseline and 6-month follow-up(Baseline and 6-month follow-up)
- 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(Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up)
- 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(Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up)
- 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(Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up)
- Changes in five activity indicators (steps, 'sedentary minutes', 'lightly active minutes', calories burn, and sleep time)(Baseline, 12-month post-intervention, 6-month follow-up)
- 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(Baseline, Immediate post-intervention, 12-month post-intervention, 6-month follow-up)
研究者
Dr. Kim, Youngwon
Assistant Professor
The University of Hong Kong