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

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

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.

Study Overview

• Status: Completed
• Conditions: Health Behaviour Change; Self-monitoring of Health
• Intervention / Treatment: Device: Do-it-yourself devices

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Zeist, Utrecht, Netherlands, 3704 HE
      • Netherlands Organisation for Applied Scientific Research (TNO)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Do-it-yourself devices; All subjects will use do-it-yourself devices for self-monitoring health parameters

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.; Other 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of complete datasets	percentage is calculated for total complete datasets as well as complete datasets per device	end of study (after 13 weeks)
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
self-measured blood pressure		baseline + weekly from week 1 until week 13
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
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)
Fasting blood glucose level	self-assessed after overnight fast (at least eight hours)	twice per week at baseline and from week 1 until 13
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
blood cholesterol levels	self-assessed	baseline and after 13 weeks (end of study)
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
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
change in subjective quality of life as assessed with RAND-36 questionnaire		baseline and week 13

Collaborators and Investigators

• Sponsor: W.J. Pasman
• Investigators: Principal Investigator: Wilrike J Pasman, PhD, Netherlands Organisation for Applied Scientific Research (TNO); Study Director: Ben van Ommen, Dr. ir., Netherlands Organisation for Applied Scientific Research (TNO)

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Health behavior; Blood Glucose Self-Monitoring; Self-measurement; Do-it-yourself devices; User-experiences; Methodology, Evaluation; Personal health records; Self Blood Pressure Monitoring
• Other Study ID Numbers: P9608