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Trial registered on ANZCTR


Registration number
ACTRN12619001481167
Ethics application status
Approved
Date submitted
17/09/2019
Date registered
28/10/2019
Date last updated
16/03/2020
Date data sharing statement initially provided
28/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What factors impact on the effectiveness of digital tools to promote lifestyle modification: a preliminary observational study.
Scientific title
Triggering Australian adults' to modify their diet and exercise habits by deploying digital health tools.
Secondary ID [1] 298849 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 313905 0
Condition category
Condition code
Diet and Nutrition 312318 312318 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 week longitudinal cohort study to identify the impact of pre-identified factors on engagement with digital tools in the context of weight management. Digital tools will be deployed over a 2 week period (T=0, T=1). Follow-up interviews will be conducted at weeks 4, 8 and 12 (T=3, T=4, T=5) by either phone or online surveys.

Interview 1 (T=0)
In the first interview participants (100) will be pre-screened for body dysmorphia using the cosmetic procedure screening questionnaire for body dysmorphic disorder (COPS) tool. Participants will complete an digital survey about their snacking habits and knowledge of calorie values of common foods. The participant will also be invited to complete the readiness for change (S-Weight) 6-item survey. The participants will be invited to nominate a time when they are most likely to eat between meals and they will be requested to monitor their consumption during this time using an electronic or paper-based food diary. The specific time will be nominated by the individual participant. Participants will be shown the Hunger app© as an option to record their snacking. The interview should take approximately 15 minutes.

Interview 2 (T=1)
Participants will be invited to discuss their food diary with the researcher and establish if they wish to modify their diet (Motivation) and whether they feel they have a strategy to address their food consumption (Ability). Participants will repeat the (S-Weight) and will also complete the validated P-Weight questionnaire. All participants will be offered freely and readily available online resources (Australian healthy eating website- http://www.eatforhealth.gov.au/guidelines/australian-guide-healthy-eating; Australian food database for nutritional facts- https://www.calorieking.com/au/en/) and introduced to the FutureMe app© which shows an individualised avatar of their future self which can be modified depending on their diet and exercise choices. The participant can choose how they might wish to appear in the future and learn how many daily calories they would need to consume and expend to achieve that goal. Interviews 1 and 2 (T=0, T=1) will be video-recorded. Video recordings of the demonstration of the digital tools will be reviewed by an expert in non-verbal communication using a previously validated tool. The interview should take approximately 15 minutes.

Interview 3-5 (T=2, T=3 T=4)
Phone interviews will be conducted weeks 4, 8 and 12. Participants will repeat the readiness for change (S-Weight) survey. They will also be invited to discuss their experience of following the FutureMe app© recommendations. Any steps they have taken to achieve the goals they set for themselves will be recorded. The interview should take approximately 5 minutes.

The study will take place on site at the Melbourne Clinical School, University of Notre Dame Australia. Recruitment will be facilitated by the research team. A research officer with previous experience in conducting qualitative interviews will deliver the intervention.
Intervention code [1] 315216 0
Lifestyle
Comparator / control treatment
'No control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320968 0
Outcome 1: Actions taken to promote weight management
This outcome will be assessed by using participant actions survey designed specifically for this study.
Timepoint [1] 320968 0
Timepoints: 2, 3, 4. Triggering will be assessed at two, four (primary endpoint) and eight weeks.





Primary outcome [2] 321755 0
Outcome 2: Stage of change
This outcome will be assessed using the S-weight survey.
Timepoint [2] 321755 0
Timepoints: T=0, 1, 2, 3, 4
Stage of change will be assessed at weeks 0, 1, 2 (primary endpoint), 4, and 8.
Secondary outcome [1] 373559 0
Outcome 3:Participant Engagement
This outcome will be assessed using the NVC Checklist-a non-verbal communication assessment tool (Park & Park 2018).
Timepoint [1] 373559 0
Participant engagement assessed at T=0 (week 1) and T=1 (week 2) using video recording of interaction with digital health tools (Future Me, Hunger App). NVC Checklist (NVC) instrument will be applied by expert in NVC.

Secondary outcome [2] 374247 0
Outcome 4:Food Literacy
This outcome will be assessed using a survey designed for the purposes of this study. Questions will assess individuals’ knowledge of food literacy including calorie values of common snacks. Survey is being designed specifically for this study.
Timepoint [2] 374247 0
Timepoint: T=0 (week 1)

Eligibility
Key inclusion criteria
Inclusion:
1. Adults able to give informed consent
2. Adults able to read and speak English
3. Interested in or considering weight management (regardless of current Body Mass Index) and
4. No body dysmorphia as assessed using a recognised tool
5. Have access to a smart phone
6. Not pregnant
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Purposive sampling will be conducted to recruit participants of both genders in three age groups: 18-30, 30-50, 50 and older. The proportion of people likely to be triggered by the Future Me© app to make weight loss attempts from our previous RCT is 20%. Therefore, a sample of 100 participants will detect a similar proportion triggered within 5% margin of error at 99% confidence level. Given an attrition of 20% we aim to recruit 100 participants with a final sample estimated at 80 participants. This provides a minimum convenience sample of 25 participants in each age category.

Descriptive statistics will be used to summarise the participants recruited to this study. This will include the age, gender, stage of change, processes of change and non-verbal behaviour scores. The stage of change data for the participants will be recorded as categorical data and compared to the non-verbal behaviour scores and P-weight scores (numeric data). Statistical significance will be evaluated using t-tests to compare stage of change, processes of change and nonverbal communication.

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 14757 0
Werribee Mercy Hospital - Werribee
Recruitment postcode(s) [1] 27989 0
3030 - Werribee

Funding & Sponsors
Funding source category [1] 303397 0
Other Collaborative groups
Name [1] 303397 0
Digital Health CRC
Address [1] 303397 0
Level 3/55 Harrington Street
The Rocks NSW 2000
Country [1] 303397 0
Australia
Primary sponsor type
Individual
Name
Professor Moyez Jiwa
Address
The University of Notre Dame Australia, School of Medicine, Melbourne Clinical School
300 Princes Highway Werribee, Victoria 3030
Country
Australia
Secondary sponsor category [1] 303899 0
None
Name [1] 303899 0
Address [1] 303899 0
Country [1] 303899 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303926 0
Mercy Health HREC
Ethics committee address [1] 303926 0
300 Princes Highway Werribee, Melbourne, Victoria 3030
Ethics committee country [1] 303926 0
Australia
Date submitted for ethics approval [1] 303926 0
31/05/2019
Approval date [1] 303926 0
10/12/2019
Ethics approval number [1] 303926 0
2019-016

Summary
Brief summary
In today's society, snacking has become a regular activity that is affecting the food views and lifestyles of many adults. Regular snacking may simply be the way an individual consumes what they require. But others are consuming snacks that are of poor nutritional value and high in sugar and fat. These types of “snack” foods are being consumed more often and these poor eating habits increase the likelihood of weight gain.
We hypothesise that it is this type of snacking behaviour that can be targeted to improve weight mangement for those individuals motivated and able to limit the consumption of snack foods.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95278 0
Prof Moyez Jiwa
Address 95278 0
The University of Notre Dame Australia, School of Medicine, Melbourne Clinical School
300 Princes Highway Werribee, Victoria 3030
Country 95278 0
Australia
Phone 95278 0
+61 02 8204 4259
Fax 95278 0
Email 95278 0
moyez.jiwa@nd.edu.au
Contact person for public queries
Name 95279 0
Mrs Epi Kanjo
Address 95279 0
The University of Notre Dame Australia, School of Medicine, Melbourne Clinical School
300 Princes Highway Werribee, Victoria 3030
Country 95279 0
Australia
Phone 95279 0
+61 02 8204 4262
Fax 95279 0
Email 95279 0
epi.kanjo@nd.edu.au
Contact person for scientific queries
Name 95280 0
Prof Moyez Jiwa
Address 95280 0
The University of Notre Dame Australia, School of Medicine, Melbourne Clinical School
300 Princes Highway Werribee, Victoria 3030
Country 95280 0
Australia
Phone 95280 0
+61 02 8204 4259
Fax 95280 0
Email 95280 0
moyez.jiwa@nd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only.
When will data be available (start and end dates)?
It is expected the data will be available immediately following publication, with no end date.
Available to whom?
Data will be made available on a case-by-case basis at the discretion of the principal sponsor.
Available for what types of analyses?
Available for any type of analysis.
How or where can data be obtained?
Data will be made available upon approval by the principal investigator.
email: moyez.jiwa@nd.edu.au
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 4693 0
Study protocol
Citation [1] 4693 0
Link [1] 4693 0
Email [1] 4693 0
epi.kanjo@nd.edu.au
Other [1] 4693 0
Attachment [1] 4693 0
Summary results
No Results