This trial is active, not recruiting.

Conditions self-monitoring of health, health behaviour change
Treatment do-it-yourself devices
Sponsor W.J. Pasman
Start date June 2014
End date November 2014
Trial size 30 participants
Trial identifier NCT02166684, P9608


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
All subjects will use do-it-yourself devices for self-monitoring health parameters
do-it-yourself devices Medisana Vifit - advanced activity tracker
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.

Primary Outcomes

Percentage of complete datasets
time frame: end of study (after 13 weeks)
Health behaviour change
time frame: baseline and after 13 weeks (end of study)
User-experiences with do-it-yourself devices
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
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

Eligibility Criteria

Male or female participants from 18 years up to 67 years old.

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.

Additional Information

Official title The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
Principal investigator Wilrike J Pasman, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by TNO.