Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000005651
Ethics application status
Not yet submitted
Date submitted
13/12/2013
Date registered
2/01/2014
Date last updated
2/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Smartphone Exercise Application in the Primary Health care Setting to reduce Type 2 Diabetes Risk
Scientific title
Effect of the Jawbone Up Smartphone Exercise Application on physical activity levels and AusDrisk score in participants over the age of 35 who are at high risk of developing diabetes: a pilot study
Secondary ID [1] 283772 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 290748 0
Condition category
Condition code
Metabolic and Endocrine 291112 291112 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Active intervention group will receive a Jawbone Up smartphone application and wristband to use for the duration of the study. A Medical student will fit the Jawbone to the patient and assist in setting up the Smartphone application. They will be encouraged to use the application on a 24 hour basis but they will be free to choose how much they use it over the period of the study.
The Jawbone UP wristband and application for a smartphone tracks the wearers steps, distance, calories burned and time spent active versus idle. This information is sent to the smartphone via bluetooth and recorded. The smartphone application can also be used to log the users calorie consumption. Participants will be encouraged to wear the wristband throughout the 50 week period to record their exercise and calorie consumption. Adherence will be assessed when the patient returns to remeasure their personal data (weight, height, waist circumference and blood pressure) at weeks 12, 26, 38 and 50.
Intervention code [1] 288463 0
Lifestyle
Comparator / control treatment
The control group will be informed about using a pedometer/smartphone application to assist in monitoring the quantity of exercise but will not be otherwise assisted regarding the purchase or use of the pedometer device.
Control group
Active

Outcomes
Primary outcome [1] 291099 0
The anticipated outcome for the project is a measurable increase in the physical activity (walking) in the active intervention group when using the Jawbone smartphone application and wristband.
Timepoint [1] 291099 0
Week 12, 26, 38 and 50
Secondary outcome [1] 306001 0
A decrease in the risk of developing type 2 diabetes in the active intervention group when assessed with the AusDrisk tool
Timepoint [1] 306001 0
Week 12, 26, 38 and 50

Eligibility
Key inclusion criteria
NSW residents aged 35 years and over
Intermediate to high risk of developing type 2 diabetes
AusDrisk Score of 12+
Participants must be able to speak fluent English
Participants must be able to use a Smartphone
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with a low risk of developing type 2 diabetes and a AusDrisk score below 12
Individuals below the age of 35
Individuals unable to speak fluent English
Individuals unable to function a Smartphone

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
General Practices from Inner West Sydney Medicare Local will be recruited to participate in the study. Each practice will then be asked to screen patients in their waiting room > 35 years old, with the AusDrisk tool. All those who score over 12 will be invited to participate in the research study by their GP.
Participants will then be provided with information regarding the recommended daily calorie consumption and exercise requirements for their age and gender to decrease their risk of developing type 2 Diabetes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation method: Participants will be randomised by a computer generated system that will be allocated externally to the practice. The GP completes recruitment by entering participant details into a web page which then allocates which patients will be entered into the intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study, therefore only a small number of participants are required to achieve the objectives of our research. We calculated a convenience sample size of 30 participants will give an indication to the effectiveness of the intervention. Due to the small sample size we do not anticipate to generate a meaningful effect size estimate, however, the results will inform us of the feasibility and potential modifications for future studies.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/01/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288438 0
University
Name [1] 288438 0
University of Notre Dame Sydney
Country [1] 288438 0
Australia
Primary sponsor type
Individual
Name
Dr Charlotte Hespe
Address
University of Notre Dame Sydney
160 Oxford St
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 287140 0
Individual
Name [1] 287140 0
Professor Max Bulsara
Address [1] 287140 0
Univeristy of Notre Dame Fremantle
19 Mouat St
Fremantle
WA 6959
Country [1] 287140 0
Australia
Other collaborator category [1] 277733 0
Individual
Name [1] 277733 0
Mark Aicken
Address [1] 277733 0
Univeristy of Notre Dame Sydney
160 Oxford St
Darlinghurst
NSW 2010
Country [1] 277733 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290313 0
The University of Notre Dame Human Research Ethics Committee
Ethics committee address [1] 290313 0
160 Oxford St
Darlinghurst
NSW 2010
Ethics committee country [1] 290313 0
Australia
Date submitted for ethics approval [1] 290313 0
16/12/2013
Approval date [1] 290313 0
Ethics approval number [1] 290313 0

Summary
Brief summary
The aim of this study is to determine the effectiveness of Smartphone application technology as a brief primary care intervention to increase sustained physical activity levels and decrease the risk of developing type 2 diabetes.
30 participants over the age of 35 who are at high risk of developing diabetes will be selected. Participants diabetes risk will be calculated using the AusDrisk tool.
The participants will be divided into two randomised groups. The active intervention group will be introduced to the Smartphone application while the Control intervention group will not. The participants weight, height, waist circumference, blood pressure and AusDrisk score will be measured in both groups at weeks 12, 26, 38 and 50.
The anticipated outcome for the project is a measurable increase in the physical activity and decease in AusDrisk score in the active intervention group compared to the control intervention group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44994 0
Dr Charlotte Hespe
Address 44994 0
University of Notre Dame Sydney
160 Oxford St
Darlinghurst
NSW 2010
Country 44994 0
Australia
Phone 44994 0
+61 2 8204 4480
Fax 44994 0
Email 44994 0
charlotte.hespe@nd.edu.au
Contact person for public queries
Name 44995 0
Dr Charlotte Hespe
Address 44995 0
University of Notre Dame Sydney
160 Oxford St
Darlinghurst
NSW 2010
Country 44995 0
Australia
Phone 44995 0
+61 2 8204 4480
Fax 44995 0
Email 44995 0
charlotte.hespe@nd.edu.au
Contact person for scientific queries
Name 44996 0
Dr Charlotte Hespe
Address 44996 0
University of Notre Dame Sydney
160 Oxford St
Darlinghurst
NSW 2010
Country 44996 0
Australia
Phone 44996 0
+61 2 8204 4480
Fax 44996 0
Email 44996 0
charlotte.hespe@nd.edu.au

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
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