The first objective of this study is to evaluate the potential of do-it-yourself devices for self-measuring health parameters by subjects in obtaining interesting data. The second objective of this study is to evaluate if increased awareness of own…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
algemeen gezondheid en gedrag
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Potential of do-it-yourself devices for self-measuring health parameters by
subjects will be assessed by the percentage of useful datasets. This should be
at least 80%. Besides, the percentage of useful datasets for each individual
device should be at least 80% to be considered eligible for do-it-yourself
studies.
Effects of self-monitoring on actual behaviour change will be established by
comparing baseline values for food intake and physical activity as measured by
the Lifestyle-questionnaire with the values at the end of the study.
The hypothesis that awareness in own health status functions as motivational
instrument for changing health behaviour will be tested with a questionnaire on
attitude towards health behaviour. This questionnaire will be administered at
baseline and at the end of the study.
Secondary outcome
All data collected with the devices for self-measured weight, physical
activity, food intake, blood glucose, blood pressure and blood cholesterol will
be analysed, to identify changes in these health parameters over time.
Usability of the devices will be assessed with a questionnaire and focus groups
on user-experience with do-it-yourself devices in an at-home setting at the end
of the study . This questionnaire and focus group will encompass questions on
how often the devices are used, the context in which the device is used and,
the satisfaction of the user with the device and the effects of the device on
user behaviour.
The subjects will also fill out online-questionnaires on stress (DASS-21),
vitality (Vita-16) and quality of life (RAND-36) at baseline and at the end of
the study.
Background summary
There is an increasing number of possibilities for individuals to map their own
health status. Smartphone Apps, Quantified Self devices and self-tests give
individuals the opportunity to measure several aspects of their health, like
food intake, weight, blood pressure, physical activity, blood sugar and
cholesterol, with increasing accuracy. These measures can contribute to an
individual*s awareness of health status and as such serve as a motivator to
improve health. However, the usability of data resulting from self-monitoring
devices for scientific purposes has not been investigated. Also, it is not
known to which extent increased awareness in an individual*s health parameters
contributes to behaviour change and improved health status.
Study objective
The first objective of this study is to evaluate the potential of
do-it-yourself devices for self-measuring health parameters by subjects in
obtaining interesting data.
The second objective of this study is to evaluate if increased awareness of own
health status by self-measuring of health parameters leads to improved health
behaviour.
Study design
The study is designed as an open, one-group, exploratory study.
During the three-month study, the subjects will use these do-it-yourself
devices to self-monitor multiple health parameters in an at-home setting. The
frequency by which the devices have to be used varies per device.
Intervention
The intervention in this study will consist of the use of do-it-yourself
devices for self-monitoring health parameters in an at-home setting. The
included devices are an activity tracker (Medisana ViFit), a blood pressure
monitor (Medisana MTX), a blood glucose meter (Medisana MediTouch 2), a smart
scale (Medisana Smart Scale) and a cholesterol meter (Mission Cholesterol 3-1
meter). Subjects will be supplied with these devices at the training day,
except for the cholesterol meter. Subjects will use the cholesterol meter at a
TNO location at the beginning and the and at the end of the study. Subjects
will also be supplied with material and a manual for two do-it-yourself OGTT*s
(oral glucose tolerance test). Devices have to be handed in again at the end of
the study. Additionally, subjects will be given access to a food intake
application Fatsecret.
Study burden and risks
Healthy volunteers participating in this study will monitor their own health
status by using do-it-yourself devices for several health parameters for three
months. We do not foresee any health risks in using the supplied devices for
measuring health parameters. The products are commercially available and
therefore, with normal use, considered safe.
Utrechtseweg 48
Zeist 3704 HE
NL
Utrechtseweg 48
Zeist 3704 HE
NL
Listed location countries
Age
Inclusion criteria
1. Age ranging from 18 - 67 years
2. Desk-job and be less active than according to the Dutch activity guideline
3. Healthy as assessed by the: Health and lifestyle questionnaire (P9608 F02)
4. Body mass index : 20 - 30 kg/m2
5. Able to use self-monitoring devices
6. Voluntary participation
7. Having given written informed consent
8. Willing to comply with study procedures
9. Willingness to share anonymous data on bodyweight with Fatsecret (food intake app provider)
10. Willingness to share anonymous data on blood glucose, blood pressure, physical activity and bodyweight with Medisana (provider of measurement Toolkit)
11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO
12. Have a desktop or laptop with internet access at home
13. Own a Smartphone with iOS or Android.
Exclusion criteria
1. Use of concomitant medication including medication known for its effects on blood glucose, cholesterol or insulin
2. Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events
3. Having a pacemaker
4. Currently suffering from diabetes type I or type II as determined by the general practitioner
5. Reported slimming or medically prescribed diet
6. Physical, mental or practical limitations in using computerized systems
7. Exercise regularly and exceed the Dutch Standard of Healthy Physical Activity of 2.5 hours/week
8. Alcohol consumption > 28 units/week for males and > 21 units (drinks)/week for females
9. Reported unexplained weight loss or gain of > 2 kg in the three months prior to the pre-study screening
10. Not having one of the TNO locations in Delft, Den Haag or Rijswijk as posting
11. Partner or first or second degree relative from TNO personnel stationed at a TNO location in Zeist, Leiden, Hoofddorp or Soesterberg
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49064.028.14 |