Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000693921
Ethics application status
Approved
Date submitted
6/07/2011
Date registered
7/07/2011
Date last updated
30/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using an iPhone application to support meal replacement weight loss programs
Scientific title
Efficacy of an iPhone application via a Weight Management Mentor in increasing retention and weight loss in meal replacement weight loss program in overweight Australian women: A randomized control trial
Secondary ID [1] 262583 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight/obesity 268250 0
Condition category
Condition code
Diet and Nutrition 268382 268382 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an iPhone app that uses prompting and behavioral techniques to support women on a meal replacement diet. This app provides daily prompts over the duration of the trial (8 weeks) to help women self-monitor weight and has goal-setting features derived from social cognitive theory
Intervention code [1] 266915 0
Behaviour
Intervention code [2] 266923 0
Treatment: Other
Intervention code [3] 266924 0
Treatment: Devices
Comparator / control treatment
The control is an iPhone app that provides information about the meal replacement program only
Control group
Active

Outcomes
Primary outcome [1] 269146 0
Weight Loss. Weight will be measured using calibrated scales and trained staff at weeks 0, 2, 4, 6 and 8. Participants in the intervention group will also be free to enter their weight into the program each day for 8 weeks using their own scales at home.
Timepoint [1] 269146 0
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcome [1] 279036 0
Compliance to the meal replacement program will be assessed by collecting un-used meal sachets.
Timepoint [1] 279036 0
0, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcome [2] 279037 0
Engagement with the app
Timepoint [2] 279037 0
Continuously throughout the 8 weeks via interaction logs. Every time a person logs into the program, there will be a record of their interaction. This will occur throughout the whole trial.

Eligibility
Key inclusion criteria
Adult women
Overweight or obese (ie BMI 25-40)
Have an iPhone
Be willing to participate in a meal replacement study
Not previously diagnosed with diabetes or heart disease.
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diabetes
Healthy weight
No iPhone

Study design
Purpose of the study
Educational / counselling / training
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
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
6/07/2011
Date of last participant enrolment
Anticipated
Actual
18/07/2011
Date of last data collection
Anticipated
Actual
19/09/2011
Sample size
Target
60
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 267390 0
Government body
Name [1] 267390 0
CSIRO
Country [1] 267390 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13 Kintore Avenue, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 266450 0
None
Name [1] 266450 0
Address [1] 266450 0
Country [1] 266450 0
Australia
Secondary sponsor category [2] 266455 0
None
Name [2] 266455 0
Address [2] 266455 0
Country [2] 266455 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269369 0
CSIRO Human Research Ethics Committee
Ethics committee address [1] 269369 0
Ethics committee country [1] 269369 0
Australia
Date submitted for ethics approval [1] 269369 0
13/12/2010
Approval date [1] 269369 0
29/04/2011
Ethics approval number [1] 269369 0

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

Contacts
Principal investigator
Name 32842 0
Dr Emily Brindal
Address 32842 0
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country 32842 0
Australia
Phone 32842 0
+61883050633
Fax 32842 0
Email 32842 0
[email protected]
Contact person for public queries
Name 16089 0
Emily Brindal
Address 16089 0
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country 16089 0
Australia
Phone 16089 0
+61883050633
Fax 16089 0
Email 16089 0
[email protected]
Contact person for scientific queries
Name 7017 0
Emily Brindal
Address 7017 0
Gate 13 Kintore Avenue, Adelaide, South Australia 5000
Country 7017 0
Australia
Phone 7017 0
+61883050633
Fax 7017 0
Email 7017 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.