Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001194358
Ethics application status
Approved
Date submitted
12/08/2017
Date registered
16/08/2017
Date last updated
1/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Online planning tool for reducing unhealthy snacking
Scientific title
Online planning tool for reducing unhealthy snacking in middle-aged and older Australians
Secondary ID [1] 292610 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low health literacy 304301 0
Unhealthy snacking 304302 0
Condition category
Condition code
Public Health 303656 303656 0 0
Other public health
Diet and Nutrition 303657 303657 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention aims to: (1) investigate the impact of an online planning tool on unhealthy snacking behaviour at one-month follow-up; (2) compare this effect amongst higher and lower health literacy groups, and; (3) investigate possible mediating factors or predictors of the effectiveness of the intervention, and how this relates to health literacy.

Participants will be randomly allocated to one of 3 conditions*:
• Volitional help sheet
• Detailed plan
• Snacking tips sheet

All will complete a 20min online survey (Survey 1). This will include demographic questions and measures relating to health literacy and health behaviour. Depending on which condition participants have been assigned to, some will design their own healthy snacking plan, while others receive either a volitional help sheet, or a sheet with snacking tips.

One-week after Survey 1 is completed, participants are emailed a reminder of either their plan, help sheet, or tip sheet. One-month after Survey 1 is completed, participants complete Survey 2 (10mins).

The study will be conducted online via two Qualtrics surveys. Both surveys will be designed by Ms Julie Ayre, a PhD candidate from the Sydney School of Public Health, The University of Sydney.

*The three conditions:

Volitional help sheet:

This consists of 4 steps that guide the user through the process of developing an appropriate plan.

• Step1: Sometimes we snack because we are hungry, but there are lots of other reasons too. Think about your snacks in the last week. Below is a list of ‘snack moments.’ These are times when people tend to choose unhealthy snacks or eat too much. Choose 3 snack moments from the list that happened to you the most often in the last week. [List of snack moments].
• Step 2: Below are your top 3 snack moments. Some snack moments will be more important than others. Choose the 1 that you would be happiest to change. [User chooses from 3 previously selected snack moments]
• Step 3: Great! Your most important snack moment was snacking because you are bored.
• The last step is to come up with a plan! Choose the solution that you think will work best for you. Drag it into the space on the right. [List of solutions]
• Step 4: Imagine how your plan might feel.[examples of scenarios when this might happen]. The final step is to make sure the plan is realistic. How hard do you think it will be to do this plan for the next month [Slider from very easy to very hard. If the user selects a number 7 they will be prompted to revise the plan]

Detailed plan:

Text: We want you to plan how you will change your unhealthy snacking behaviour each day because forming plans has been shown to improve snacking habits.
You are free to choose how you do this but we want you to formulate your plans in as much detail as possible. Please pay attention to the situations in which you will implement (carry out) these plans. Focus on situations when you are not hungry but find yourself snacking.

Snacking tips sheet:

This is a modified version of the NDSS Healthy snacking tips sheet with references to diabetes, blood glucose and carbohydrate removed (see https://static.diabetesaustralia.com.au/s/fileassets/diabetes-australia/201fcd3d-3b7c-4f5f-a81a-46a200b1fa84.pdf ).
Intervention code [1] 298833 0
Behaviour
Comparator / control treatment
The snacking tips sheet condition will act as a passive control in this study.

The effect of the planning tools (volitional help sheet; detailed planning; information sheet) will be assessed using ANCOVA (analysis of covariance), controlling for: baseline values, age, sex, and language spoken at home.

Orthogonal planned contrasts will be used to test if the volitional help sheet is superior to the detailed planning intervention, and if both of these interventions are superior to the passive control intervention (information sheet) on the primary outcomes.
Control group
Active

Outcomes
Primary outcome [1] 303012 0
Maintenance self-efficacy (3 items, 4-point Likert scale anchored to not at all true/exactly true).
Timepoint [1] 303012 0
Survey 2 (administered one-month following Survey 1).
Primary outcome [2] 303015 0
Unhealthy snacking scores (based on self-reported diet during previous week).
Timepoint [2] 303015 0
Survey 2 (administered one-month following Survey 1).
Secondary outcome [1] 337702 0
Action Control, using 3-item self report 7-point Likert scale based on those used in Armitage 2015 (both references below are use the same approach):
- Armitage, C. J. (2015). Randomized test of a brief psychological intervention to reduce and prevent emotional eating in a community sample. Journal of Public Health, 37(3), 438-444.
- Armitage, C. J. (2015). Field experiment of a very brief worksite intervention to improve nutrition among health care workers. Journal of behavioral medicine, 38(4), 599-608.
Timepoint [1] 337702 0
Survey 1 and Survey 2 (i.e. one month after Survey 1)
Secondary outcome [2] 337703 0
Self-regulatory effort, a 5 item 7-point Likert scale (strongly disagree to strongly agree).
Timepoint [2] 337703 0
Survey 1 and Survey 2 (i.e. one month after Survey 1)

Eligibility
Key inclusion criteria
Currently living in Australia.
50% of sample must not have a tertiary education (in order to connect with lower health literacy cohort).
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Excluded is under 30 (prior to recruitment)

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)
A series of participant IDs will be generated and randomised before being sent to the company supplying the respondents (Survey Sampling International). They may then assign the numbers to the respondents as they wish - they will not be able to assign respondents to conditions in a biased or ordered manner, as the IDs will be randomly generated on our end.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The intended sample size is approximately 435 participants. Eighty-seven participants randomized to each group (totalling 261 participants) will yield ~90% power to detect moderate effect sizes (Cohen’s f = 0.25, corresponding to ANOVA effects and interaction as small as np 2 = 0.06) in the primary outcomes (maintenance self-efficacy scores; unhealthy snacking scores) and any secondary analyses, assuming a Bonferroni-adjusted two-sided alpha of 0.017 (allowing for four planned comparisons, and a correlation between the two primary outcome measures of ~ 0.25). Importantly, we expect a 40% attrition rate from Survey 1 to Survey 2, thus increasing our required sample size to 435 (i.e., 145 per group).

Randomisation will be tested using MANOVA (multivariate analysis of variance), to ensure similarity across the three groups of participants in terms of demographic and other descriptive characteristics at baseline. The effect of the planning tools (volitional help sheet; detailed planning; information sheet) will be assessed using ANCOVA (analysis of covariance), controlling for: baseline values, age, sex, and language spoken at home. Orthogonal planned contrasts will be used to test if the volitional help sheet is superior to the detailed planning intervention, and if both of these interventions are superior to the passive control intervention (information sheet) on the primary outcomes. Secondary analyses will include exploring possible mediation of behavioural change by maintenance self-efficacy by using bootstrapping procedures as outlined in Preacher and Hayes (2008; BehavResMethods 40: 879-891). The potential moderating effect of health literacy on the efficacy of planning tools will be explored by examining the interaction of intervention and health literacy in ANCOVA.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2017
Actual
14/09/2017
Date of last participant enrolment
Anticipated
4/09/2017
Actual
22/10/2017
Date of last data collection
Anticipated
13/10/2017
Actual
27/11/2017
Sample size
Target
440
Accrual to date
Final
373
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 297197 0
University
Name [1] 297197 0
The University of Sydney
Country [1] 297197 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 296205 0
None
Name [1] 296205 0
Address [1] 296205 0
Country [1] 296205 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298353 0
University of Sydney, HREC
Ethics committee address [1] 298353 0
Ethics committee country [1] 298353 0
Australia
Date submitted for ethics approval [1] 298353 0
22/06/2017
Approval date [1] 298353 0
28/08/2017
Ethics approval number [1] 298353 0

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

Contacts
Principal investigator
Name 76814 0
Prof Kirsten McCaffery
Address 76814 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 76814 0
Australia
Phone 76814 0
+61 2 9351 7220
Fax 76814 0
Email 76814 0
[email protected]
Contact person for public queries
Name 76815 0
Julie Ayre
Address 76815 0
Rm 129a Edward Ford Building A27
University of Sydney
NSW 2006
Country 76815 0
Australia
Phone 76815 0
+61 2 9351 7789
Fax 76815 0
Email 76815 0
[email protected]
Contact person for scientific queries
Name 76816 0
Kirsten McCaffery
Address 76816 0
307F Edward Ford Building (A27)
University of Sydney
NSW 2006
Country 76816 0
Australia
Phone 76816 0
+61 2 9351 7220
Fax 76816 0
Email 76816 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
EmbaseRandomized trial of planning tools to reduce unhealthy snacking: Implications for health literacy.2019https://dx.doi.org/10.1371/journal.pone.0209863
N.B. These documents automatically identified may not have been verified by the study sponsor.