The Potential of Do-it-yourself Devices for Obtaining Personal Health Data (P4@TNO)

W.J. Pasman

Status: Completed

Conditions: Self-monitoring of Health; Health Behaviour Change

Treatments: Device: Do-it-yourself devices

Study type: Interventional

Funder types: Other

Identifiers

NCT02166684

P9608

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 67 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

33 participants in 1 patient group

Do-it-yourself devices

Experimental group

Description:

All subjects will use do-it-yourself devices for self-monitoring health parameters

Treatment:

Device: Do-it-yourself devices