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Trial registered on ANZCTR


Registration number
ACTRN12614000474651
Ethics application status
Approved
Date submitted
4/04/2014
Date registered
7/05/2014
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of an eHealth application to support weight loss maintenance
Scientific title
Using an intelligent versus simple smartphone application in order to support weight loss in adults wishing to maintain recent weight loss.
Secondary ID [1] 284396 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy weight maintenance 291575 0
Psychological wellbeing 291576 0
Condition category
Condition code
Public Health 291955 291955 0 0
Other public health
Diet and Nutrition 292168 292168 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A smartphone application (app) for supporting weight loss maintenance. This app provides tracking tools for weight, diet, exercise and wellbeing and advice on psychological wellbeing, diet and exercise in order to help people maintain their weight losses. To increase interaction, the app prompts people daily and provides intelligent feedback based on data entered into the tracking tool. Participants will have access to this app for 24 weeks. They will be free to interact with the app as much as they like.
Intervention code [1] 289129 0
Lifestyle
Intervention code [2] 289130 0
Behaviour
Intervention code [3] 289131 0
Prevention
Comparator / control treatment
A simplified smartphone application that provides static information about diet and exercise (identical to that in the intervention app) and only the weight monitoring tool without intelligent feeback.
Control group
Active

Outcomes
Primary outcome [1] 291856 0
Weight change measured in person using calibrated scales.
Timepoint [1] 291856 0
weeks 4, 8, 12, 24
Secondary outcome [1] 307675 0
Changes in psychological wellbeing will be assessed using Positive and Negative Affect Schedule, Fordyce Happiness Scale and the Depression Anxiety Stress Scales completed via a computer at clinic visits.
Timepoint [1] 307675 0
Weeks 4, 8, 12, 24
Secondary outcome [2] 307676 0
Participant evaluations of intervention app will be assessed using our own evaluation questionnaire that will be completed on a computer during a clinic visit.
Timepoint [2] 307676 0
Weeks 4, 12, 24
Secondary outcome [3] 307677 0
Usage of intervention app and features will be recorded using an interaction database which logs user interactions with the phone
Timepoint [3] 307677 0
This will be recorded continuously throughout the trial by the app

Eligibility
Key inclusion criteria
*Adults (18+; Males & females)
*Lost weight at least 5% of their body weight within last 24 months
*Want to continue or maintain their weight loss
*Have access to bathroom scales
*Own a Smartphone
*Happy to attend clinic in Adelaide 5 times
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Pregnancy/breast feeding (or planning pregnancy)
*Active cancer

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 289042 0
Government body
Name [1] 289042 0
CSIRO Animal, Food & Health Sciences
Address [1] 289042 0
Gate 13, Kintore Ave, Adelaide, SA 5000
Country [1] 289042 0
Australia
Funding source category [2] 291525 0
Charities/Societies/Foundations
Name [2] 291525 0
Bupa Health Foundation
Address [2] 291525 0
Bupa Health Foundation
Bupa Level 2, 50 Bridge Street Sydney NSW 2000
Country [2] 291525 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13, Kintore Ave, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 287757 0
None
Name [1] 287757 0
Address [1] 287757 0
Country [1] 287757 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290839 0
CSIRO Animal, Food & Health Sciences HREC
Ethics committee address [1] 290839 0
Gate 13, Kintore Ave, Adelaide, SA 5000
Ethics committee country [1] 290839 0
Australia
Date submitted for ethics approval [1] 290839 0
07/02/2014
Approval date [1] 290839 0
02/04/2014
Ethics approval number [1] 290839 0
14/02

Summary
Brief summary
We aim to develop a smartphone application (app) for supporting weight loss maintenance and evaluate the efficacy of the app in a 12 week clinical trial with 12 week follow up. The overall objective of this project is to develop and validate our app which aims to support people to maintain the weight losses they have achieved.
Trial website
Trial related presentations / publications
Brindal, e., Hendrie, G, Freyne, J. (2016). Combining Persuasive Technology With Behavioral Theory to Support Weight Maintenance Through a Mobile Phone App: Protocol for the MotiMate App. JMIR Research Protocols, Jan-Mar; 5(1): e5
Public notes

Contacts
Principal investigator
Name 47538 0
Dr Emily Brindal
Address 47538 0
CSIRO Animal, Food & Health Sciences, Gate 13 Kintore Ave, Adelaide, SA 5000
Country 47538 0
Australia
Phone 47538 0
+61883050633
Fax 47538 0
Email 47538 0
emily.brindal@csiro.au
Contact person for public queries
Name 47539 0
Ms Vanessa Courage
Address 47539 0
CSIRO Animal, Food & Health Sciences, Gate 13 Kintore Ave, Adelaide, SA 5000
Country 47539 0
Australia
Phone 47539 0
+61883038863
Fax 47539 0
Email 47539 0
vanessa.courage@csiro.au
Contact person for scientific queries
Name 47540 0
Dr Emily Brindal
Address 47540 0
CSIRO Animal, Food & Health Sciences, Gate 13 Kintore Ave, Adelaide, SA 5000
Country 47540 0
Australia
Phone 47540 0
+61883050633
Fax 47540 0
Email 47540 0
emily.brindal@csiro.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary