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

NCT ID: NCT02166684

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Do-it-yourself devices

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

Group Type: EXPERIMENTAL

Do-it-yourself devices

Intervention Type: DEVICE

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.

Interventions

Do-it-yourself devices

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.

Intervention Type: DEVICE

Other Intervention Names

Medisana Vifit - advanced activity tracker; Medisana MTX Blood pressure monitor - systolic and diastolic blood pressure; Medisana BS 440 BT scale - body weight; Medisana MediTouch 2 - blood glucose meter; FatSecret app - food intake application; Mission Cholesterol 3-1 meter - blood cholesterol level; Do-it-yourself Oral Glucose Tolerance Test

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

W.J. Pasman

OTHER

Sponsor Role: lead

Responsible Party

W.J. Pasman

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wilrike J Pasman, PhD

Role: PRINCIPAL_INVESTIGATOR

Netherlands Organisation for Applied Scientific Research (TNO)

Ben van Ommen, Dr. ir.

Role: STUDY_DIRECTOR

Netherlands Organisation for Applied Scientific Research (TNO)

Locations

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

P9608

Identifier Type: -

Identifier Source: org_study_id