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

NCT02166684 | Completed

• 1 other identifier: P9608
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• self-measured blood pressure

  baseline + weekly from week 1 until week 13

• self-recorded food intake

  week 1, week 7 and week 13

• daily physical activity

  daily during 13 weeks (baseline - end of study)

• Fasting blood glucose level

  twice per week at baseline and from week 1 until 13

• body weight

  three times per week at baseline and from week 1 to 13

Study Arms (1)

Do-it-yourself devices

EXPERIMENTAL

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

Device: Do-it-yourself devices

Interventions

Do-it-yourself devices 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.

Also known as: 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

Do-it-yourself devices

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ranging from 18 - 67 years
• Desk-job and not exceed the Dutch Standard of Healthy Physical Activity of 5 hours/week
• Healthy as assessed by the Health and Lifestyle questionnaire
• Body mass index: 20 - 30 kg/m2
• Able to use self-monitoring devices
• Voluntary participation
• Having given written informed consent
• Willing to comply with study procedures
• Willingness to share pseudonymised data on food intake with external party Fatsecret (food intake app provider)
• Willingness to share pseudonymised data on blood glucose, blood pressure, physical activity and body weight with external party Medisana (provider of measurement Toolkit)
• 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
• Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data by TNO
• Have a desktop or laptop with internet access at home
• Subjects should own a Smartphone with Bluetooth that runs either a recent version of iOS or Android.
• Having one of the TNO locations in Delft, Den Haag or Rijswijk as posting

You may not qualify if:

• Use of concomitant medication including medication known for its effects on blood glucose, cholesterol or insulin
• Having a history of medical or surgical events that may significantly affect the study outcome, including physical limitations or cardio-vascular events
• Having a pacemaker
• Currently suffering from diabetes type I or type II as determined by the general practitioner
• Reported slimming or medically prescribed diet
• Physical, mental or practical limitations in using computerized systems
• Alcohol consumption \> 28 units/week for males and \> 21 units (drinks)/week for females
• Reported unexplained weight loss or gain of \> 2 kg in the three months prior to the pre-study screening
• 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.

Sponsors & Collaborators

• W.J. Pasman: lead

Study Sites (1)

Netherlands Organisation for Applied Scientific Research (TNO)

Zeist, Utrecht, 3704 HE, Netherlands

Location

MeSH Terms

Conditions

Health Behavior

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Wilrike J Pasman, PhD

  Netherlands Organisation for Applied Scientific Research (TNO)

  PRINCIPAL INVESTIGATOR

• Ben van Ommen, Dr. ir.

  Netherlands Organisation for Applied Scientific Research (TNO)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 18, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

NL (1)