Netherlands Organisation for Applied Scientific Research (TNO)
Zeist, Utrecht, 3704 HE, Netherlands
NCT Number: NCT02166684
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.
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Notify Me18 year–67 year
All sexes
Interventional
Not applicable
Zeist, Utrecht, 3704 HE, Netherlands
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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, FatSecret app - food intake application, Mission Cholesterol 3-1 meter - blood cholesterol level, Do-it-yourself Oral Glucose Tolerance Test
Time frame: end of study (after 13 weeks)
percentage is calculated for total complete datasets as well as complete datasets per device
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
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
Time frame: baseline + weekly from week 1 until week 13
Time frame: week 1, week 7 and week 13
every of the three periods, food intake will be recorded at two week days and one weekend day
Time frame: daily during 13 weeks (baseline - end of study)
wearable activity tracker that measures number of steps taken, duration of activity and estimates the number of calories burned
Time frame: twice per week at baseline and from week 1 until 13
self-assessed after overnight fast (at least eight hours)
Time frame: three times per week at baseline and from week 1 to 13
self-assessed with a smart scale that also calculates BMI and body fat percentage
Time frame: baseline and after 13 weeks (end of study)
self-assessed
Time frame: week 1 and week 13
do-it-yourself version of OGTT; blood glucose levels will be assessed using the Medisana MediTouch 2
Time frame: baseline and week 13
Time frame: baseline and week 13
Time frame: baseline and week 13
W.J. Pasman
Other
The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
Acronym: P4@TNO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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