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

W.J. Pasman33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Self-monitoring of Health Health Behaviour Change

Interventions

Do-it-yourself devicesDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 67 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ranging from 18 - 67 years 2. Desk-job and not exceed the Dutch Standard of Healthy Physical Activity of 5 hours/week 3. Healthy as assessed by the Health and Lifestyle questionnaire 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 pseudonymised data on food intake with external party Fatsecret (food intake app provider) 10. Willingness to share pseudonymised data on blood glucose, blood pressure, physical activity and body weight with external party Medisana (provider of measurement Toolkit) 11. 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 12. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO 13. Have a desktop or laptop with internet access at home 14. Subjects should own a Smartphone with Bluetooth that runs either a recent version of iOS or Android. 15. Having one of the TNO locations in Delft, Den Haag or Rijswijk as posting 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. Alcohol consumption \> 28 units/week for males and \> 21 units (drinks)/week for females 8. Reported unexplained weight loss or gain of \> 2 kg in the three months prior to the pre-study screening 9. 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.

Locations (1)

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, Netherlands

Outcomes

Primary Outcomes

Percentage of complete datasets

percentage is calculated for total complete datasets as well as complete datasets per device

Time frame: 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

Time frame: 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

Time frame: after 13 weeks (end of study)

Secondary Outcomes

self-measured blood pressure

Time frame: 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

Time frame: 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

Time frame: daily during 13 weeks (baseline - end of study)

Fasting blood glucose level

self-assessed after overnight fast (at least eight hours)

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.