Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000547741
Ethics application status
Approved
Date submitted
6/05/2013
Date registered
15/05/2013
Date last updated
13/04/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a smart phone application to support meal replacement weight loss programs
Scientific title
Using a smart phone to deliver a weight loss intervention program for overweight/obese participants - The effect of static versus supportive features for weight loss
Secondary ID [1] 282452 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 289065 0
Condition category
Condition code
Diet and Nutrition 289401 289401 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive an iPhone application that uses prompting, interactive feedback and planning and monitoring to support them on their weight loss program (a partial meal replacement program). Participants are prompted 3x a day by the phone to remind them to monitor their weight and food intake through a meal diary which provides real-time compliance feedback.
The intervention will last 12 weeks.
There is no requirement that the participant interacts with the app for a set time per day.
The partial meal replacement program requires participants to replace 2 meals a day with two meal replacement shakes. Participants will acquire sachets from the study clinic to be made and eaten in a free-living scenario. Participants will be asked to follow the program for 24 weeks. The meal replacements are a new, confidential formulation and contain approx 1000kJ each.
Intervention code [1] 287096 0
Behaviour
Intervention code [2] 287146 0
Treatment: Other
Comparator / control treatment
The control is a static, information-only iPhone application. Information provided is identical to the information section of the intervention app and covers the specifics of the partial meal replacement, the issues with achieving weight loss, some basic dieting advice and tips and some basic advice about exercise.
This app will also be available for 12 weeks.
There is no requirement that the participant interacts with the app for a set time per day.
The control participants will receive access to the same meal replacement program as the intervention group for 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 289515 0
Weight loss, calculated from weight measures taken at in-person visits to the Clinic, using a validated digital scale.
Timepoint [1] 289515 0
24 weeks (12-week intervention, 12-week follow-up)
Secondary outcome [1] 302663 0
Interaction with the app captured objectively using usage logs that are saved automatically and updated each time a person accesses the app. This is done using a specially designed algorithm and database.
Timepoint [1] 302663 0
continuous across 24 weeks
Secondary outcome [2] 314030 0
Qualitative data on how participants use planning strategies during their time on the diet.
Timepoint [2] 314030 0
Week 28-30, for a single interview

Eligibility
Key inclusion criteria
*Adult (18 years and over)
*Have an iPhone
*Self-reported BMI greater than 25kg/m2
*Access to scales and ability to measure weight
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active cancers, pregnant, breastfeeding, Type I Diabetes

Study design
Purpose of the study
Treatment
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2013
Actual
15/05/2013
Date of last participant enrolment
Anticipated
Actual
13/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287237 0
Government body
Name [1] 287237 0
CSIRO Animal, Food and Health Sciences
Country [1] 287237 0
Australia
Primary sponsor type
Government body
Name
CSIRO Animal, Food and Health Sciences
Address
Gate 13 Kintore Ave, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 285987 0
None
Name [1] 285987 0
Address [1] 285987 0
Country [1] 285987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289217 0
CSIRO Animal, Food and Health Sciences HREC
Ethics committee address [1] 289217 0
Gate 13 Kintore Ave, Adelaide, SA 5000
Ethics committee country [1] 289217 0
Australia
Date submitted for ethics approval [1] 289217 0
20/12/2012
Approval date [1] 289217 0
04/02/2013
Ethics approval number [1] 289217 0
12/14

Summary
Brief summary
Participants will be randomised to one of the two conditions and prescribed the same diet which they will be asked to follow for a 24-week period. The primary purpose of this study is to evaluate the effectiveness of different mobile phone applications designed to support people to lose weight by undertaking a Meal Replacement Program over a 24-week period
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39806 0
Dr Emily Brindal
Address 39806 0
CSIRO, Animal, Food and Health Sciences, Gate 13 Kintore Avenue, Adelaide, SA 5000
Country 39806 0
Australia
Phone 39806 0
+61 8 83050633
Fax 39806 0
Email 39806 0
[email protected]
Contact person for public queries
Name 39807 0
Ms Anne McGuffin
Address 39807 0
CSIRO, Animal, Food and Health Sciences, Gate 13 Kintore Avenue, Adelaide, SA 5000
Country 39807 0
Australia
Phone 39807 0
+61 8 8303 8988
Fax 39807 0
Email 39807 0
[email protected]
Contact person for scientific queries
Name 39808 0
Dr Emily Brindal
Address 39808 0
CSIRO, Animal, Food and Health Sciences, Gate 13 Kintore Ave, Adelaide, SA 5000
Country 39808 0
Australia
Phone 39808 0
+61 8 83050633
Fax 39808 0
Email 39808 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
SourceTitleYear of PublicationDOI
EmbaseCohort analysis of a 24-week randomized controlled trial to assess the efficacy of a novel, partial meal replacement program targetingweight loss and risk factor reduction in overweight/obese adults.2016https://dx.doi.org/10.3390/nu8050265
N.B. These documents automatically identified may not have been verified by the study sponsor.