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

Health Behaviour Change Clinical Trial

— P4@TNO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166684
• Other study ID #: P9608
• Status: Completed
• Phase: N/A
• First received: June 16, 2014
• Last updated: December 19, 2014
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 67 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Health Behaviour Change
• Self-monitoring of Health

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Netherlands	Netherlands Organisation for Applied Scientific Research (TNO)	Zeist	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
W.J. Pasman

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of complete datasets	percentage is calculated for total complete datasets as well as complete datasets per device	end of study (after 13 weeks)	No
Primary	Health behaviour change	established by comparing baseline values for food intake and physical activity as measured by a Lifestyle-questionnaire	baseline and after 13 weeks (end of study)	No
Primary	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	after 13 weeks (end of study)	No
Secondary	self-measured blood pressure		baseline + weekly from week 1 until week 13	No
Secondary	self-recorded food intake	every of the three periods, food intake will be recorded at two week days and one weekend day	week 1, week 7 and week 13	No
Secondary	daily physical activity	wearable activity tracker that measures number of steps taken, duration of activity and estimates the number of calories burned	daily during 13 weeks (baseline - end of study)	No
Secondary	Fasting blood glucose level	self-assessed after overnight fast (at least eight hours)	twice per week at baseline and from week 1 until 13	No
Secondary	body weight	self-assessed with a smart scale that also calculates BMI and body fat percentage	three times per week at baseline and from week 1 to 13	No
Secondary	blood cholesterol levels	self-assessed	baseline and after 13 weeks (end of study)	No
Secondary	oral glucose tolerance test (OGTT)	do-it-yourself version of OGTT; blood glucose levels will be assessed using the Medisana MediTouch 2	week 1 and week 13	No
Secondary	change in vitality as assessed with a vitality questionnaire (Vita-16)		baseline and week 13	No
Secondary	change in subjective stress level as assessed with DASS-21 questionnaire		baseline and week 13	No
Secondary	change in subjective quality of life as assessed with RAND-36 questionnaire		baseline and week 13	No