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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Do-it-yourself devices | Experimental | All subjects will use do-it-yourself devices for self-monitoring health parameters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Do-it-yourself devices | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of complete datasets | percentage is calculated for total complete datasets as well as complete datasets per device | 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 | 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 | after 13 weeks (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| self-measured blood pressure | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilrike J Pasman, PhD | Netherlands Organisation for Applied Scientific Research (TNO) | Principal Investigator |
| Ben van Ommen, Dr. ir. | Netherlands Organisation for Applied Scientific Research (TNO) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Organisation for Applied Scientific Research (TNO) | Zeist | Utrecht | 3704 HE | Netherlands |
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| ID | Term |
|---|---|
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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 | daily during 13 weeks (baseline - end of study) |
| Fasting blood glucose level | self-assessed after overnight fast (at least eight hours) | 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 | three times per week at baseline and from week 1 to 13 |
| blood cholesterol levels | self-assessed | 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 | 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 |
| change in subjective quality of life as assessed with RAND-36 questionnaire | baseline and week 13 |
| D006439 |
| Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |