Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000883718
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
8/08/2013
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Do images of a personalized future body shape help with weight loss in overweight individuals? A randomized controlled study
Scientific title
Do images of a personalized future body shape help with weight loss in overweight individuals? A randomized controlled study
Secondary ID [1] 282890 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 289710 0
Condition category
Condition code
Diet and Nutrition 290031 290031 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim: To determine if a personalized future body shape image can increase motivation to adhere to a diet and exercise regimen. Objective: To conduct a randomized controlled trial with the Future Me application. Method: 1.In this randomized controlled trial participants must provide Informed consent 2.The participants will be randomized in to two arms to receive the images immediately or after 8 weeks. Images will be generated on an ipad mini device and printed on a colour printer for the participant. 3.All participants will receive photo of their body shape as it might appear at 4,8,12, 26 and 52 weeks in the future. They will receive dietary advice from a 15 minute consultation with a general practitioner or counsellor at the weight watchers group as per : National Health and Medical Research Council (2013) Clinical practice guidelines for the management of overweight and obesity in adults, adolescents and children in Australia. The images provided will show the whole body as it might appear if the participant adhered to a diet and exercise program. 4.The participants will be weighed at weekly intervals for 16 weeks after recruitment. This will be the proxy measure of compliance with the diet and exercise program. The participants will also be encouraged to maintain a food diary and document their exercise program.
5. At the 16 week mark, half of the participants will be randomly selected to receive a new photo image, while the remaining subjects will carry on with their original images. the participants will be followed up for a further 8 weeks.
6.A small number of participants will be invited to join a focus group 6.The effect of the intervention will be assessed by analyzing quantitative data and interview transcripts
Intervention code [1] 287594 0
Behaviour
Comparator / control treatment
To determine whether any difference exists between those receiving the intervention immediately and those receiving intervention after 8 weeks (Control).
Control group
Active

Outcomes
Primary outcome [1] 290079 0
Weight loss (kg) for each subject in the study as recorded on their own weighing scales. Participants will also be weighed every four weeks by researchers on calibrated digital scales. Weekly weights recorded independently by the participants can be included in the analysis.
Timepoint [1] 290079 0
Assessed on a weekly and 4-weekly basis for 24 weeks from randomisation
Primary outcome [2] 290080 0
Number of participants approached and the number recruited
Timepoint [2] 290080 0
At 4 months from randomization
Secondary outcome [1] 303907 0
Interview and focus group transcripts will be analysed guided by Technology Acceptance Model (TAM). This will focus on satisfaction with the intervention
Timepoint [1] 303907 0
At 6 months after randomization
Secondary outcome [2] 307515 0
Thematic analysis of recorded transcribed interviews.
Timepoint [2] 307515 0
At 8 weeks, 16 weeks and 24 weeks after randomisation

Eligibility
Key inclusion criteria
Eligible participants are people with BMI greater than 25 (overweight) and seeking advise about weight loss.
They should be able to provide informed consent.
Participants will be over 16 years of age. Those below 18 years of age will also be required to provide parental consent.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant or breast feeding, or become pregnant during the study period will be excluded.

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)
People attending a session at the Weight Watchers Federation WA or at the general practice clinic at Murray Medical Center, Woodvale park or clients at the Mandurah Recreation Centre or staff and students at Curtin University who are seeking weight loss advice will be eligible to participate. The interested participants will be provided with Participant Information Sheet and Consent Form. Total of 150 participants will be enrolled in the study and they will be randomized into two arms with 75 participants in each arm: a. One arm will receive the intervention immediately or b. One arm will receive the intervention after 8 weeks. At 16 weeks both arms will be randomised and one group will receive the intervention again. Allocation will be concealed as the participants will be centrally randomised by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study will be randomized using a randomized table created by computer software (i.e. computer sequence generation)

The total of 80 participants enrolled in the study will be randomized using this computer software into two arms.

Arm 1: Receive Intervention Immediately
Arm 2: Receive Intervention after 8 weeks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2014
Actual
2/04/2014
Date of last participant enrolment
Anticipated
Actual
1/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
145
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287696 0
Self funded/Unfunded
Name [1] 287696 0
Country [1] 287696 0
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
GPO Box U1987
Perth, WA 6845
Country
Australia
Secondary sponsor category [1] 286429 0
None
Name [1] 286429 0
Address [1] 286429 0
Country [1] 286429 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289656 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 289656 0
Ethics committee country [1] 289656 0
Australia
Date submitted for ethics approval [1] 289656 0
30/07/2013
Approval date [1] 289656 0
07/08/2013
Ethics approval number [1] 289656 0
HR112/2013

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

Contacts
Principal investigator
Name 41682 0
Prof Moyez Jiwa
Address 41682 0
Curtin University,
GPO box U1987
Perth WA 6845
Country 41682 0
Australia
Phone 41682 0
+ 61 8 9266 1768
Fax 41682 0
Email 41682 0
[email protected]
Contact person for public queries
Name 41683 0
Gemma Ossolinski
Address 41683 0
Curtin University
GPO box U1987
Perth WA 6845
Country 41683 0
Australia
Phone 41683 0
+ 61 8 9266 1768
Fax 41683 0
Email 41683 0
[email protected]
Contact person for scientific queries
Name 41684 0
Moyez Jiwa
Address 41684 0
Curtin University
GPO box U1987
Perth WA 6845
Country 41684 0
Australia
Phone 41684 0
+ 61 8 9266 1768
Fax 41684 0
Email 41684 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.