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Trial registered on ANZCTR


Registration number
ACTRN12618000640202
Ethics application status
Approved
Date submitted
28/03/2018
Date registered
23/04/2018
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Right on Cue: Technologies for Managing Unhealthy Behavioural Cues, A Pilot Study
Scientific title
A pilot evaluation of MunchIO: A smartphone app for reducing unhealthy snack food consumption in obese and overweight adults.
Secondary ID [1] 294463 0
Nil known
Universal Trial Number (UTN)
U1111-1200-7943
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
overweight 304582 0
obesity 304583 0
Condition category
Condition code
Diet and Nutrition 303916 303916 0 0
Other diet and nutrition disorders
Diet and Nutrition 306352 306352 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MunchIO app will be trialled as an intervention app for those wanting to begin a diet with the aim of reducing unhealthy snacking.

Participants will be randomised into either an intervention or control group. Participants in the intervention group will receive full access to the MunchIO app, including novel cue monitoring and implementation intention features aimed at planning against unhealthy snacking.

During the first week of monitoring, all participants will log snack intake, respond to randomised prompts and complete an evening meal summary in the MunchIO app. On completion of the first week, participants randomised to the intervention condition will receive a cue monitoring prompt containing their top three snacking cues requiring implementation intention planning (if-then style plans). The cue monitoring component will utilise an odds ratio algorithm between the snack entries and random prompts to identify top cue exposures that lead to unhealthy snacking (Szumilas 2010; Verhoeven, Adriaanse, de Vet, Fennis, et al. 2014). Implementation intention read in the format of “if I am stressed, I will go for a walk”. Intervention participants will be reminded daily of their cue monitoring and implementation intentions.

The duration of the intervention will be for a 28 day period. After the 28-day monitoring period has elapsed, all content will be available to all users. This means that participants in the control group will receive content and information support the same as what the intervention group had available after the first week.

The completion of the snack entries, the random prompts and the completion of the evening report each day will provide an indication of participants adherence to the intervention.
Intervention code [1] 299037 0
Behaviour
Comparator / control treatment
Participants in the control group will have restricted access to content in the MunchIO app; they will not receive access to the cue monitoring and implementation intention content. Participants will otherwise experience the app identically to the intervention group; they will receive the same behavioural support content (including snack analytics tools and general healthy eating advice).

After 28-days of monitoring snacking, the trial will end and participants will be asked to complete a survey regarding their eating habits and experiences with the app. In addition, two usability surveys will also be distributed. At this point, all participants will receive full access to the app, including both the intervention cue-monitoring and implementation features. Participants will retain full access to the app beyond the 28-day trial period.
Control group
Active

Outcomes
Primary outcome [1] 303266 0
The primary outcome of this research is to examine the number of users who actively engage with the MunchIO app. Engagement is measured as a composite outcome consisting of continued daily snack entries, access to intervention content, responses to random prompts and evening entries. Engagement will be measured during the full 28-day study period. Snack entries will be measured by comparing completed entries against daily reported total snacks in evening entries. Access to intervention content will be measured as whether participants complete daily implementation intention planning activities. Responses to random prompts will include measuring whether participants complete pre-scheduled prompts each day. Evening entries will also be measured through whether participants complete these each day. Content within each item is adapted from Verhoeven, Aukje AC, et al. "Identifying the ‘if’for ‘if-then’plans: Combining implementation intentions with cue-monitoring targeting unhealthy snacking behaviour." Psychology & health 29.12 (2014): 1476-1492.
Timepoint [1] 303266 0
Participants will utilise the MunchIO app for a four week period. Psychological determinant data will be collected at the beginning and end of the study. Snacking data will be collected throughout the study period.
Secondary outcome [1] 338482 0
The secondary outcome of this research is to examine whether participant daily snacking frequencies (as measured by the number of snack entries) changes after the participants are exposed to the behavioural support (implementation intention) content. Measurement of snacking entries is adapted from Verhoeven, Aukje AC, et al. "Identifying the ‘if’for ‘if-then’plans: Combining implementation intentions with cue-monitoring targeting unhealthy snacking behaviour." Psychology & health 29.12 (2014): 1476-1492.
Timepoint [1] 338482 0
Participants in the intervention condition will be issued the behavioural support after one week of monitoring. We will examine the frequency of their snack consumption after this period and compare it to the average daily snacks reported during the first week of monitoring.

Eligibility
Key inclusion criteria
To be eligible for enrolment interested individuals will need to report via the app that they are a) being aged between 18 and 65 years old; b) able to read English; c) have a BMI in the overweight/obese range and d) own a compatible mobile phone.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded from the study if they report a) they have an Eating Disorder and/or b) are not using the MunchIO app for a serious attempt to reduce unhealthy snacking habits.

Healthy volunteers are able to download the app. But only the eating patterns of individuals with a BMI in the overweight/obese range will be examined.

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)
Allocation concealment will be facilitated by the MunchIO app allocating participants to control and intervention groups without researcher involvement.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The MunchIO app will apply simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Preliminary analysis for the MunchIO app’s effectiveness in reducing unhealthy snacking habits will utilise multi-level logistic regression analysis, situational antecedents and linear regression analysis. Multi-level logistic regression analysis will be used to examine situational cues that trigger snack intake. Situational antecedents will be used to predict snacking occasions within each individual’s data. Linear regression analysis will be used to test for the association between stimulus control and snacking, and to examine differences between the control and intervention groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2018
Actual
Date of last participant enrolment
Anticipated
3/08/2018
Actual
Date of last data collection
Anticipated
31/08/2018
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297309 0
University
Name [1] 297309 0
University of Tasmania
Country [1] 297309 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Sandy Bay, Hobart
University of Tasmania
Private Bag 51
HOBART TAS 7001
Country
Australia
Secondary sponsor category [1] 296288 0
None
Name [1] 296288 0
Address [1] 296288 0
Country [1] 296288 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298414 0
Tasmania Health and Medical Human Research Ethics Committee
Ethics committee address [1] 298414 0
Ethics committee country [1] 298414 0
Australia
Date submitted for ethics approval [1] 298414 0
21/08/2017
Approval date [1] 298414 0
22/12/2017
Ethics approval number [1] 298414 0
H0016800

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

Contacts
Principal investigator
Name 77006 0
Dr Kristy de Salas
Address 77006 0
Room 464,
Centenary Building,
School of Technology, Environments and Design,
University of Tasmania,
Churchill Avenue
Sandy Bay TASMANIA 7005
AUSTRALIA
Country 77006 0
Australia
Phone 77006 0
+61 3 6226 6220
Fax 77006 0
Email 77006 0
[email protected]
Contact person for public queries
Name 77007 0
Kristy de Salas
Address 77007 0
Room 464,
Centenary Building,
School of Technology, Environments and Design,
University of Tasmania,
Churchill Avenue
Sandy Bay TASMANIA 7005
AUSTRALIA
Country 77007 0
Australia
Phone 77007 0
+61 3 6226 6220
Fax 77007 0
Email 77007 0
[email protected]
Contact person for scientific queries
Name 77008 0
Kristy de Salas
Address 77008 0
Room 464,
Centenary Building,
School of Technology, Environments and Design,
University of Tasmania,
Churchill Avenue
Sandy Bay TASMANIA 7005
AUSTRALIA
Country 77008 0
Australia
Phone 77008 0
+61 3 6226 6220
Fax 77008 0
Email 77008 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

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