Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001218684
Ethics application status
Approved
Date submitted
28/10/2014
Date registered
19/11/2014
Date last updated
19/11/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Activity wristbands: how accurate are they in measuring energy expenditure and number of steps?
Scientific title
The accuracy of the Fitbit, Jawbone UP, Garmin Vivofit for the measurement of energy expenditure and number of steps in healthy volunteers
Secondary ID [1] 285555 0
Nil
Universal Trial Number (UTN)
U1111-1163-4520
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 293375 0
Condition category
Condition code
Diet and Nutrition 293659 293659 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fitbit one worn on the dominant hip
Fitbit wristbands worn on the left and right wrist
Jawbone UP worn on the left and right wrist
Garmin Vivofit worn on the left and right wrist
All devices will be worn throughout the exercise tests and the activities of dailiy living, this will be observed by the investigator.
Exercises to be performed treadmill walking at 4.8 k/h, cycling at 1.5 W/kg body mass each of which will last for 6 minutes.
The activities of daily living (whisking eggs, folding clothes, sweeping the floor, making a sandwich, playing on an iPad and typing) will each last 5 minutes.
All exercises will be completed during 2 trials (exactly the same- separated by at least 24 hours), to determine the reliability of the measures on all devices. All the devices will be worn at the same time by all participants during all activities on both trials. The total time for each trial will be 90 minutes.
Intervention code [1] 290501 0
Diagnosis / Prognosis
Intervention code [2] 290546 0
Lifestyle
Comparator / control treatment
All devices will be compared to the oxygen cost of the exercise measured via an expired air sample (Cortex Metalyser 2) for energy expenditure and accelerometry (actigtaph GT3-XPW).
Control group
Active

Outcomes
Primary outcome [1] 293473 0
The difference in energy expenditure provided by the Fitbit One, Fitbit wristband, Jawbone Up and Garmin Vivofit and the energy expenditure calculated via oxygen consumption using the Cortex Metalyser 2.
Timepoint [1] 293473 0
End of each exercise/activity, trial 1 and trail 2.
Primary outcome [2] 293474 0
The difference in number of steps provided by the Fitbit One, Fitbit wristband, Jawbone Up and Garmin Vivofit and the accelerometer.
Timepoint [2] 293474 0
End of each exercise/activity trial 1 and trial 2
Secondary outcome [1] 311118 0
The % differences in the energy and step measures provided by the dominant and non dominant side of the body for each of the Fitbit One, Fitbit wristband, Jawbone UP and Garmin Vivofit. With energy measured using the Cortex Metalyser 2 and steps via Actigraph GT3-XPW.
Timepoint [1] 311118 0
For each exercise/activity on both trials
Secondary outcome [2] 311119 0
The difference between energy expenditure values provided by the Fitbit One, Fitbit wristband, Jawbone Up and Garrmin Vivofit between trial 1 and trial 2.
Timepoint [2] 311119 0
End of each exercise/activity for both trials (ie trial 1& 2)

Eligibility
Key inclusion criteria
Reportedly in good health, no history of heart problems, no pacemakers, not pregnant, aged 18-65 years, living in living in Dunedin, New Zealand and engaged in regular activity (3 times per week for at least 30 minutes each session).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Anyone who does not meet the inclusion criteria or reports to have a muscular-skeletal injury or has suffered from nausea or diarrhoea in the 48 hours prior to any trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/11/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6440 0
New Zealand
State/province [1] 6440 0

Funding & Sponsors
Funding source category [1] 290158 0
University
Name [1] 290158 0
Department of Human Nutrition
University of Otago
Country [1] 290158 0
New Zealand
Primary sponsor type
University
Name
Univerity of Otago
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 288867 0
None
Name [1] 288867 0
Address [1] 288867 0
Country [1] 288867 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291868 0
University of Otago Human Ethics Committee
Ethics committee address [1] 291868 0
Ethics committee country [1] 291868 0
New Zealand
Date submitted for ethics approval [1] 291868 0
Approval date [1] 291868 0
20/10/2014
Ethics approval number [1] 291868 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52350 0
Dr Katherine Black
Address 52350 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 52350 0
New Zealand
Phone 52350 0
+ 64 3 479 8358
Fax 52350 0
Email 52350 0
[email protected]
Contact person for public queries
Name 52351 0
Katherine Black
Address 52351 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 52351 0
New Zealand
Phone 52351 0
+ 64 3 479 8358
Fax 52351 0
Email 52351 0
[email protected]
Contact person for scientific queries
Name 52352 0
Katherine Black
Address 52352 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin
9054
Country 52352 0
New Zealand
Phone 52352 0
+ 64 3 479 8358
Fax 52352 0
Email 52352 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.