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

Not Applicable

Completed

• Conditions: Health Behaviour Change; Self-monitoring of Health
• Interventions: Device: Do-it-yourself devices

• Registration Number: NCT02166684
• Lead Sponsor: W.J. Pasman

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.

Study Timeline

• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-16
• Study First Posted: 2014-06-18
• Study Start: 2014-09
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-19
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Do-it-yourself devices	Do-it-yourself devices	All subjects will use do-it-yourself devices for self-monitoring health parameters

Primary Outcome Measures

Name	Time	Method
Percentage of complete datasets	end of study (after 13 weeks)	percentage is calculated for total complete datasets as well as complete datasets per device
Health behaviour change	baseline and after 13 weeks (end of study)	established by comparing baseline values for food intake and physical activity as measured by a Lifestyle-questionnaire
User-experiences with do-it-yourself devices	after 13 weeks (end of study)	as measured by a questionnaire on user-experiences as well as focus group interviews for more in-depth information

Secondary Outcome Measures

Name	Time	Method
self-measured blood pressure	baseline + weekly from week 1 until week 13
body weight	three times per week at baseline and from week 1 to 13	self-assessed with a smart scale that also calculates BMI and body fat percentage
self-recorded food intake	week 1, week 7 and week 13	every of the three periods, food intake will be recorded at two week days and one weekend day
daily physical activity	daily during 13 weeks (baseline - end of study)	wearable activity tracker that measures number of steps taken, duration of activity and estimates the number of calories burned
change in subjective quality of life as assessed with RAND-36 questionnaire	baseline and week 13
blood cholesterol levels	baseline and after 13 weeks (end of study)	self-assessed
Fasting blood glucose level	twice per week at baseline and from week 1 until 13	self-assessed after overnight fast (at least eight hours)
oral glucose tolerance test (OGTT)	week 1 and week 13	do-it-yourself version of OGTT; blood glucose levels will be assessed using the Medisana MediTouch 2
change in vitality as assessed with a vitality questionnaire (Vita-16)	baseline and week 13
change in subjective stress level as assessed with DASS-21 questionnaire	baseline and week 13

Trial Locations

Locations (1)

Netherlands Organisation for Applied Scientific Research (TNO); 🇳🇱 Zeist, Utrecht, Netherlands