Self-monitoring of HealthP4@TNONCT02166684
The Potential of Do-it-yourself Devices for Obtaining Personal Health Data
A study testing Do-it-yourself devices in people with Self-monitoring of Health and Health Behaviour Change, run by W.J. Pasman at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-monitoring of Health, Health Behaviour Change
- What is being tested?
- Do-it-yourself devices
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, 3704 HE
About this study
Official title: The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
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.
Read the detailed description
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.
- Conditions
- Self-monitoring of Health, Health Behaviour Change
- Being tested
- Do-it-yourself devices
- Keywords
- Do-it-yourself devices, User-experiences, Health behavior, Self-measurement, Methodology, Evaluation, Personal health records, Blood Glucose Self-Monitoring, Self Blood Pressure Monitoring
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do-it-yourself devicesDevice
Also called Medisana Vifit - advanced activity tracker, Medisana MTX Blood pressure monitor - systolic and diastolic blood pressure, Medisana BS 440 BT scale - body weight, Medisana MediTouch 2 - blood glucose meter
Medisana Vifit is worn every day all-day by each subject
Subjects use Medisana MTX Blood pressure monitor twice per week for 13 weeks to measure their blood pressure.
Blood cholesterol is measured by subjects using the Mission Cholesterol 3-1 meter once at baseline and once after 13 weeks
Subjects use Medisana BS 440 BT scale daily
In three weeks (week 1, week 7 and week 13) subjects self-record food intake at three days (two week days and on weekend day) using the FatSecret app.
Subjects self-measure fasting blood glucose twice per week for 13 weeks.
Subjects perform a do-it-yourself Oral Glucose Tolerance Test in week 1 and week 13. Subjects use the Medisana MediTouch 2 for assessing blood glucose levels at t=0, t=30, t=60, t=90 and t=120.
| Study group | Role | What they receive |
|---|---|---|
| Do-it-yourself devices | Experimental | All subjects will use do-it-yourself devices for self-monitoring health parameters Receives: Device: Do-it-yourself devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of complete datasets
percentage is calculated for total complete datasets as well as complete datasets per device
Measured: end of study (after 13 weeks)
Health behaviour change
established by comparing baseline values for food intake and physical activity as measured by a Lifestyle-questionnaire
Measured: baseline and after 13 weeks (end of study)
User-experiences with do-it-yourself devices
as measured by a questionnaire on user-experiences as well as focus group interviews for more in-depth information
Measured: after 13 weeks (end of study)
Secondary outcomes (10)
self-measured blood pressure
Measured: baseline + weekly from week 1 until week 13
self-recorded food intake
every of the three periods, food intake will be recorded at two week days and one weekend day
Measured: week 1, week 7 and week 13
daily physical activity
wearable activity tracker that measures number of steps taken, duration of activity and estimates the number of calories burned
Measured: daily during 13 weeks (baseline - end of study)
Fasting blood glucose level
self-assessed after overnight fast (at least eight hours)
Measured: twice per week at baseline and from week 1 until 13
body weight
self-assessed with a smart scale that also calculates BMI and body fat percentage
Measured: three times per week at baseline and from week 1 to 13
blood cholesterol levels
self-assessed
Measured: baseline and after 13 weeks (end of study)
oral glucose tolerance test (OGTT)
do-it-yourself version of OGTT; blood glucose levels will be assessed using the Medisana MediTouch 2
Measured: week 1 and week 13
change in vitality as assessed with a vitality questionnaire (Vita-16)
Measured: baseline and week 13
change in subjective stress level as assessed with DASS-21 questionnaire
Measured: baseline and week 13
change in subjective quality of life as assessed with RAND-36 questionnaire
Measured: baseline and week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-monitoring of HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.J. Pasman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, W.J. Pasman, TNO
- Investigators
- Wilrike J Pasman, PhD, Principal investigator, Netherlands Organisation for Applied Scientific Research (TNO)Ben van Ommen, Dr. ir., Study director, Netherlands Organisation for Applied Scientific Research (TNO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166684
- Sponsor's protocol ID
- P9608
- Acronym
- P4@TNO
- Status last verified
- Dec 2014
- First submitted
- 16 Jun 2014
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
- ClinicalTrials.gov ID
- NCT02166684
- Acronym / sponsor ID
- P4@TNO / P9608
- Conditions
- Self-monitoring of Health, Health Behaviour Change
- Keywords
- Do-it-yourself devices, User-experiences, Health behavior, Self-measurement, Methodology, Evaluation, Personal health records, Blood Glucose Self-Monitoring, Self Blood Pressure Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- W.J. PasmanUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Do-it-yourself devices | Experimental | Device: Do-it-yourself devicesAll subjects will use do-it-yourself devices for self-monitoring health parameters |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Do-it-yourself devicesAlso: Medisana Vifit - advanced activity tracker, Medisana MTX Blood pressure monitor - systolic and diastolic blood pressure, Medisana BS 440 BT scale - body weight, Medisana MediTouch 2 - blood glucose meterMedisana Vifit is worn every day all-day by each subject Subjects use Medisana MTX Blood pressure monitor twice per week for 13 weeks to measure their blood pressure. Blood cholesterol is measured by subjects using the Mission Cholesterol 3-1 meter once at baseline and once after 13 weeks Subjects use Medisana BS 440 BT scale daily In three weeks (week 1, week 7 and week 13) subjects self-record food intake at three days (two week days and on weekend day) using the FatSecret app. Subjects self-measure fasting blood glucose twice per week for 13 weeks. Subjects perform a do-it-yourself Oral Glucose Tolerance Test in week 1 and week 13. Subjects use the Medisana MediTouch 2 for assessing blood glucose levels at t=0, t=30, t=60, t=90 and t=120. | Device | Do-it-yourself devices |
Primary outcome
Percentage of complete datasets
Time frame: end of study (after 13 weeks)
percentage is calculated for total complete datasets as well as complete datasets per device
Health behaviour change
Time frame: 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
Time frame: 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
10 secondary outcomes
self-measured blood pressure
Time frame: baseline + weekly from week 1 until week 13
self-recorded food intake
Time frame: week 1, week 7 and week 13
daily physical activity
Time frame: daily during 13 weeks (baseline - end of study)
Fasting blood glucose level
Time frame: twice per week at baseline and from week 1 until 13
body weight
Time frame: three times per week at baseline and from week 1 to 13
blood cholesterol levels
Time frame: baseline and after 13 weeks (end of study)
oral glucose tolerance test (OGTT)
Time frame: week 1 and week 13
change in vitality as assessed with a vitality questionnaire (Vita-16)
Time frame: baseline and week 13
change in subjective stress level as assessed with DASS-21 questionnaire
Time frame: baseline and week 13
change in subjective quality of life as assessed with RAND-36 questionnaire
Time frame: baseline and week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wilrike J Pasman, PhD principal investigator
Netherlands Organisation for Applied Scientific Research (TNO)
Ben van Ommen, Dr. ir. study director
Netherlands Organisation for Applied Scientific Research (TNO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Do-it-yourself devices in people with Self-monitoring of Health and Health Behaviour Change, run by W.J. Pasman at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of complete datasets (time frame: end of study (after 13 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2014.