The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Percentage of complete datasets
研究概览
简要总结
The study aims to evaluate whether do-it-yourself devices for self-measuring health parameters by subjects can be used for obtaining useful data in scientific studies.
Besides, the study aims to evaluate if increased awareness of own health status by self-monitoring health parameters also serves as motivational instrument for changing health behaviour.
详细描述
During this three month study subjects will self-monitor multiple parameters of health with do-it-yourself devices. Subjects are supplied with devices for measuring physical activity, food intake, body weight, blood pressure, blood glucose level and blood cholesterol level. These devices have to be used with varying frequencies, ranging from continuously to only a baseline- and endpoint measure.
Subjects will have to upload data resulting from these self-measures to an encoded account on an online portal.
At any time during the study, subjects can log-on to this portal, to gain insight in their own health parameters.
Only encoded subject data can be exported from this portal for data analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ranging from 18 - 67 years
- •Desk-job and not exceed the Dutch Standard of Healthy Physical Activity of 5 hours/week
- •Healthy as assessed by the Health and Lifestyle questionnaire
- •Body mass index: 20 - 30 kg/m2
- •Able to use self-monitoring devices
- •Voluntary participation
- •Having given written informed consent
- •Willing to comply with study procedures
- •Willingness to share pseudonymised data on food intake with external party Fatsecret (food intake app provider)
- •Willingness to share pseudonymised data on blood glucose, blood pressure, physical activity and body weight with external party Medisana (provider of measurement Toolkit)
- •Willingness to share pseudonymised data on food intake, blood glucose, blood cholesterol, blood pressure, physical activity and body weight with the Nutrition Research Cohort (NRC) database
- •Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO
- •Have a desktop or laptop with internet access at home
- •Subjects should own a Smartphone with Bluetooth that runs either a recent version of iOS or Android.
- •Having one of the TNO locations in Delft, Den Haag or Rijswijk as posting
排除标准
- •Use of concomitant medication including medication known for its effects on blood glucose, cholesterol or insulin
- •Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events
- •Having a pacemaker
- •Currently suffering from diabetes type I or type II as determined by the general practitioner
- •Reported slimming or medically prescribed diet
- •Physical, mental or practical limitations in using computerized systems
- •Alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
- •Reported unexplained weight loss or gain of > 2 kg in the three months prior to the pre-study screening
- •Partner or first or second-degree relative from TNO personnel stationed at a TNO location in Zeist, Leiden, Hoofddorp or Soesterberg where the study protocol was developed.
结局指标
主要结局
Percentage of complete datasets
时间窗: end of study (after 13 weeks)
percentage is calculated for total complete datasets as well as complete datasets per device
Health behaviour change
时间窗: baseline and after 13 weeks (end of study)
established by comparing baseline values for food intake and physical activity as measured by a Lifestyle-questionnaire
User-experiences with do-it-yourself devices
时间窗: after 13 weeks (end of study)
as measured by a questionnaire on user-experiences as well as focus group interviews for more in-depth information
次要结局
- self-measured blood pressure(baseline + weekly from week 1 until week 13)
- body weight(three times per week at baseline and from week 1 to 13)
- self-recorded food intake(week 1, week 7 and week 13)
- daily physical activity(daily during 13 weeks (baseline - end of study))
- change in subjective quality of life as assessed with RAND-36 questionnaire(baseline and week 13)
- Fasting blood glucose level(twice per week at baseline and from week 1 until 13)
- blood cholesterol levels(baseline and after 13 weeks (end of study))
- oral glucose tolerance test (OGTT)(week 1 and week 13)
- change in vitality as assessed with a vitality questionnaire (Vita-16)(baseline and week 13)
- change in subjective stress level as assessed with DASS-21 questionnaire(baseline and week 13)
研究者
W.J. Pasman
PhD
TNO