Clinical trial NCT02166684: The Potential of Do-it-yourself Devices for Obtaining Personal Health Data
Official title: The Potential of Do-it-yourself Devices for Obtaining Personal Health Data - P4@TNO Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-monitoring of Health
Health Behaviour Change
Keywords: Do-it-yourself devices
User-experiences
Health behavior
Self-measurement
Methodology, Evaluation
Personal health records
Blood Glucose Self-Monitoring
Self Blood Pressure Monitoring
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of complete datasets
timeFrame: end of study (after 13 weeks)
measure: Health behaviour change
timeFrame: baseline and after 13 weeks (end of study)
measure: User-experiences with do-it-yourself devices
timeFrame: after 13 weeks (end of study)
Secondary outcomes:
measure: self-measured blood pressure
timeFrame: baseline + weekly from week 1 until week 13
measure: self-recorded food intake
timeFrame: week 1, week 7 and week 13
measure: daily physical activity
timeFrame: daily during 13 weeks (baseline - end of study)
measure: Fasting blood glucose level
timeFrame: twice per week at baseline and from week 1 until 13
measure: body weight
timeFrame: three times per week at baseline and from week 1 to 13
measure: blood cholesterol levels
timeFrame: baseline and after 13 weeks (end of study)
measure: oral glucose tolerance test (OGTT)
timeFrame: week 1 and week 13
measure: change in vitality as assessed with a vitality questionnaire (Vita-16)
timeFrame: baseline and week 13
measure: change in subjective stress level as assessed with DASS-21 questionnaire
timeFrame: baseline and week 13
measure: change in subjective quality of life as assessed with RAND-36 questionnaire
timeFrame: baseline and week 13
Other outcomes:
Locations:
city: Zeist
country: Netherlands
facility: Netherlands Organisation for Applied Scientific Research (TNO)
state: Utrecht
Study officials:
affiliation: Netherlands Organisation for Applied Scientific Research (TNO)
name: Wilrike J Pasman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Netherlands Organisation for Applied Scientific Research (TNO)
name: Ben van Ommen, Dr. ir.
role: STUDY_DIRECTOR
References: