Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000481279
Ethics application status
Approved
Date submitted
20/03/2018
Date registered
3/04/2018
Date last updated
3/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
VegEze: A mobile phone app to increase vegetable consumption.
Scientific title
Effect of a mobile phone application to increase vegetable consumption: An uncontrolled quantitative study of Australian adults.
Secondary ID [1] 294401 0
n/a
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diet quality 307132 0
Condition category
Condition code
Diet and Nutrition 306250 306250 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Volunteer participants download the VegEze app from the App store. This uncontrolled, quantitative study is designed to measure the effectiveness of the app in increasing daily vegetable consumption. Participation in the trial will be observed through usage of the app and completion of in built surveys at baseline, day 21 and day 90.
The timing of push notifications is standardised but the content personalised to provide recipe and meal ideas based on baseline questions of vegetable liking and cooking skills.
Intervention code [1] 300691 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305252 0
Vegetable intake (amount in serves and variety in number of types) as assessed using a validated questionnaire of self-reported vegetable intake. The validated questionnaire is called the Short Food Survey, which is now freely available online as the CSIRO Healthy Diet Score survey.
Timepoint [1] 305252 0
Baseline, Day 21 [Primary time point], and Day 90.
Secondary outcome [1] 344649 0
App usage as assessed using usage data (collected via Google Analytics)
Timepoint [1] 344649 0
Throughout the 90 day trial

Eligibility
Key inclusion criteria
Adults aged 18 years and above
Living in Australia
Owns a compatible iOS 10/11 device (including iPhone or iPad) with internet connection
Willing to download the App and participate in the 90 day pilot study
Willing to complete 3 online evaluation surveys
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Individuals change in vegetable intake will be assessed using paired samples t test.
Predictors of change in vegetable will be assessed using regression analysis.
Other relationships between app usage and change in vegetable intake will be explored.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/11/2017
Date of last participant enrolment
Anticipated
11/05/2018
Actual
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
5000
Accrual to date
4266
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299033 0
Commercial sector/Industry
Name [1] 299033 0
Horticulture Innovation Australia Limited (Hort Innovation)
Country [1] 299033 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
SP Health Pty Ltd
Address
Level 1
65 Walker Street
North Sydney
NSW 2060
Australia
Country
Australia
Secondary sponsor category [1] 298260 0
Government body
Name [1] 298260 0
CSIRO Health & Biosecurity
Address [1] 298260 0
PO BOX 10041
Adelaide
SA 5000
Australia
Country [1] 298260 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299968 0
CSIRO Human Research Ethics: Low Risk Review Panel
Ethics committee address [1] 299968 0
Ethics committee country [1] 299968 0
Australia
Date submitted for ethics approval [1] 299968 0
09/08/2017
Approval date [1] 299968 0
19/10/2017
Ethics approval number [1] 299968 0
13/2017

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2517 2517 0 0
/AnzctrAttachments/374766-LR 13_2017 Amendment 1 approval 191017.pdf (Ethics approval)

Contacts
Principal investigator
Name 82122 0
Dr Gilly Hendrie
Address 82122 0
CSIRO Health & Biosecurity
PO BOX 10041
Adelaide
SA 5000
Australia
Country 82122 0
Australia
Phone 82122 0
+61883050662
Fax 82122 0
Email 82122 0
[email protected]
Contact person for public queries
Name 82123 0
Gilly Hendrie
Address 82123 0
CSIRO Health & Biosecurity
PO BOX 10041
Adelaide
SA 5000
Australia
Country 82123 0
Australia
Phone 82123 0
+61883050662
Fax 82123 0
Email 82123 0
[email protected]
Contact person for scientific queries
Name 82124 0
Gilly Hendrie
Address 82124 0
CSIRO Health & Biosecurity
PO BOX 10041
Adelaide
SA 5000
Australia
Country 82124 0
Australia
Phone 82124 0
+61883050662
Fax 82124 0
Email 82124 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Results publication link: https://mhealth.jmir.or... [More Details]

Documents added automatically
No additional documents have been identified.