The Effect of Communicating Genetic Risk of Coronary Heart Disease and Wearable Technologies On Wearable-Device-Measured Behavioral Outcomes in East Asians: Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 414
- 主要终点
- Changes in ST (average, in minutes/day) 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: This study aims to determine the effects of communicating genetic risk for Coronary Heart Disease (CHD) alone or in combination with goal setting and prompts from a wearable device on objectively measured sedentary time (ST) in East Asians. It is hypothesized that this combination will lead to significant favorable changes in objectively ST, and that such changes will be more likely to be sustained over 6-month follow-up.
Methods: In a parallel group, randomized controlled trial, a total 414 individuals of East Asians aged over 60years will be allocated into one of three groups: 1 control and 2 intervention groups. Blood samples will be used for estimation of CHD genetic and analysis of metabolic risk markers. Genetic risk for CHD will be estimated based on recently identified 79 SNPs (associated with CHD for East Asians) using an established methodology. Questionnaires and physical measurement will be administered at Before and after the 12-month intervention and at 6-month follow-up. Each group will receive a Fitbit device. Both intervention groups will be given CHD genetic risk estimates along with lifestyle advice but one of them will additionally use Fitbit's step-goal setting and prompt functions. The primary outcome is objectively measured sedentary time. Secondary outcomes include objectively measured MVPA, calories burned, and five intermediate metabolic risk markers (total cholesterol/HDL-C/LDL-C/triglycerides).
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 (Participant, Investigator)
盲法说明
Staff without knowledge of participant information will create a computer-generated list that consists of blocks of six that contain two of each of the three groups per block in a random order. The randomisation list will be incorporated into a computer program that our staff will use for enrolment and automated random assignment of participants. Group allocation will be concealed from study staff until the 7-day pre-intervention period begins (to allow preparation of genetic risk estimates and/or calculate Fitbit step goals from baseline data) and concealed from participants until the intervention begins. Given the nature of the interventions, it is impossible for participants to be blinded to their group allocation; however, research staff analysing participants' deidentified data will remain blinded to participant group assignments.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •East Asian ancestry
- •Do not meet the WHO-recommended levels of PA (i.e., ≥150 minutes/week of moderate-intensity PA, ≥75 minutes/week of vigorous-intensity PA, or an equivalent combination of the two; determined through the IPAQ-Short Form).
排除标准
- •Previously diagnosed with CHD, and/or participation in another exercise-intervention study.
研究组 & 干预措施
Control Group
The control group will receive a Fitbit device
Intervention Group - Genetic Risk Estimate+health coaching
Genetic: Genetic Risk Estimate The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD 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). Health coaching will be incorporated as well.
干预措施: Genetic Risk Estimate + Fitbit Functions+Health Coaching (Device)
Intervention Group - Genetic Risk Estimate+health coaching
Genetic: Genetic Risk Estimate The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD 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). Health coaching will be incorporated as well.
干预措施: Genetic Risk Estimate+Health Coaching (Genetic)
Intervention Group - Genetic Risk Estimate + Fitbit Functions+health coaching
Device: Genetic Risk Estimate + Fitbit Functions The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for CHD as well as a dichotomized genetic risk category: 'increased genetic risk' or 'no increased genetic 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. Health coaching will be incorporated as well.
干预措施: Genetic Risk Estimate + Fitbit Functions+Health Coaching (Device)
结局指标
主要结局
Changes in ST (average, in minutes/day) 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
ST (average, in minutes/day) will be objectively measured by the Fitbit tracker.
次要结局
- 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 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 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)
- 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 four CHD markers (total cholesterol/HDL-C/LDL-C/triglycerides) 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 systolic/diastolic blood pressure between baseline and 6-month follow-up(Baseline and 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)
研究者
Dr. Kim, Youngwon
Assistant Professor
The University of Hong Kong