The Potential of Do-it-yourself Devices for Obtaining Personal Health Data

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study

Conditions
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Self-monitoring of Health, Health Behaviour Change

Intervention / Treatment
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* Device: Do-it-yourself devices


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Do-it-yourself devices<br>All subjects will use do-it-yourself devices for self-monitoring health parameters | Device: Do-it-yourself devices<br>* 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.<br>* Other names: Do-it-yourself Oral Glucose Tolerance Test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Do-it-yourself devices, User-experiences, Health behavior, Self-measurement, Methodology, Evaluation, Personal health records, Blood Glucose Self-Monitoring, Self Blood Pressure Monitoring