NCT03229109

Brief Summary

Monitoring of a person's physical status is a key point for maintaining of "healthy life". Wearable devices provide a unique possibility for real-time monitoring. This study aims to estimate the accuracy of Spectrophon Dehydration Body Monitor (DBM) incorporated in smartwatch Samsung Gear S2 and sport band Samsung Gear Fit2 by comparing data obtained by DBM with the total weight lost during exertion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 31, 2019

Completed
Last Updated

October 31, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

July 5, 2017

Results QC Date

November 12, 2017

Last Update Submit

October 30, 2019

Conditions

Dehydration

Keywords

dehydrationspectrophondeviceperspiration

Outcome Measures

Primary Outcomes (1)

  • Number of Measurements Grouped by Level or Error

    Number of measurements obtained with Dehydration Monitor with errors greater/less than 20% (as compared to Shekel B-200-P)

    90 minutes

Study Arms (4)

Group 1

EXPERIMENTAL

Age 18-25, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

Device: Spectrophon dehydration body monitor

Group 2

EXPERIMENTAL

Age 26-35, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

Device: Spectrophon dehydration body monitor

Group 3

EXPERIMENTAL

Age 36-45, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

Device: Spectrophon dehydration body monitor

Group 4

EXPERIMENTAL

Age 46-50, males and females, Spectrophon dehydration body monitor was attached to subject's wrist

Device: Spectrophon dehydration body monitor

Interventions

Spectrophon dehydration body monitorDEVICE

Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: older than 18, both gender.
  • Ability and willingness to sign an informed consent form for participation in the study.

You may not qualify if:

  • Presence of cardiologic or vascular disease.
  • Evidence of any other serious medical disorder.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mental Health Center

Tirat Carmel, Haifa District, 30200, Israel

Location

Tirat Carmel Mental Health Center

Tirat Carmel, Haifa District, 30200, Israel

Location

Related Publications (5)

  • Colberg SR, Sigal RJ, Fernhall B, Regensteiner JG, Blissmer BJ, Rubin RR, Chasan-Taber L, Albright AL, Braun B; American College of Sports Medicine; American Diabetes Association. Exercise and type 2 diabetes: the American College of Sports Medicine and the American Diabetes Association: joint position statement. Diabetes Care. 2010 Dec;33(12):e147-67. doi: 10.2337/dc10-9990.

    PMID: 21115758BACKGROUND

  • Craft LL, Perna FM. The Benefits of Exercise for the Clinically Depressed. Prim Care Companion J Clin Psychiatry. 2004;6(3):104-111. doi: 10.4088/pcc.v06n0301.

    PMID: 15361924BACKGROUND

  • Sternfeld B, Weltzien E, Quesenberry CP Jr, Castillo AL, Kwan M, Slattery ML, Caan BJ. Physical activity and risk of recurrence and mortality in breast cancer survivors: findings from the LACE study. Cancer Epidemiol Biomarkers Prev. 2009 Jan;18(1):87-95. doi: 10.1158/1055-9965.EPI-08-0595.

    PMID: 19124485BACKGROUND

  • Warburton DE, Nicol CW, Bredin SS. Health benefits of physical activity: the evidence. CMAJ. 2006 Mar 14;174(6):801-9. doi: 10.1503/cmaj.051351.

    PMID: 16534088BACKGROUND

  • Anastasio P, Cirillo M, Spitali L, Frangiosa A, Pollastro RM, De Santo NG. Level of hydration and renal function in healthy humans. Kidney Int. 2001 Aug;60(2):748-56. doi: 10.1046/j.1523-1755.2001.060002748.x.

    PMID: 11473658BACKGROUND

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Anatoly Kreinin
Organization
Maale Carmel Mental Health Center
kranata@gmail.com
(+972) -4-8559315

Study Officials

  • Anatoly Kreinin, MD, PHD

    Bruce Rappaport Medical Faculty, Technion, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Psychiatry Department,

Study Record Dates

First Submitted

July 5, 2017

First Posted

July 25, 2017

Study Start

May 3, 2017

Primary Completion

July 27, 2017

Study Completion

July 27, 2017

Last Updated

October 31, 2019

Results First Posted

October 31, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)