Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001421123
Ethics application status
Approved
Date submitted
2/10/2019
Date registered
15/10/2019
Date last updated
20/05/2021
Date data sharing statement initially provided
15/10/2019
Date results information initially provided
20/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing Type 2 Diabetes Risk Communication with Message Framing and Tailored Risk Feedback: An Online Randomised Controlled Trial
Scientific title
Enhancing Type 2 Diabetes Risk Communication with Message Framing and Tailored Risk Feedback: An Online Randomised Controlled Trial
Secondary ID [1] 299458 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 314669 0
Condition category
Condition code
Metabolic and Endocrine 313009 313009 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited via Amazon Mechanical Turk (MTurk) and directed to Qualtrics to complete the online survey(s). On Qualtrics, participants gave informed consent and completed a pre-screen survey to ensure that they meet the following inclusion criteria: (1) Currently not diagnosed with diabetes, (2) Score at least an intermediate (<5 points) on the AUSDRISK, and (3) only Australian and American (i.e USA) participants, qualify for the full survey. Participants meeting eligibility requirements in the pre-screen will be offered the opportunity to complete the study. While completing the full survey, participants will be presented with the health risk communication intervention which consists of 3 sections: (1) participant's Type 2 diabetes risk (either personalised or generalised risk presentation condition) (2) general information on Type 2 diabetes, and (3) health message recommending lifestyle changes (either gain- or loss-framed message condition). In the full survey, participants will rate their perceived risk of Type 2 diabetes and behavioural intentions before and after receiving the health risk communication intervention. Based on previous trials with research group members, it will take approximately 20 minutes to complete both screening and full survey. When the survey is published on MTurk, researcher MG will access website analytics on Qualtrics and Amazon MTurk daily to monitor adherence to the intervention and assess for any issues with the survey.

This cross-sectional study will employ a 2 (Framing: individualised vs generalised) x 2 (Framing: loss vs. gain) between-subjects experimental design. Each participant will be randomly assigned to one of the four message frames by an automated device embedded in the program/website: Personalised/Loss, Personalised/Gain, Generalised/Loss and Generalised/Gain.
Intervention code [1] 315708 0
Early detection / Screening
Intervention code [2] 315709 0
Prevention
Intervention code [3] 315710 0
Lifestyle
Comparator / control treatment
This cross-sectional study will employ a 2 (Framing: individualised vs generalised) x 2 (Framing: loss vs. gain) between-subjects experimental design. Each participant will be randomly assigned to one of the four message frames by an automated device embedded in the program/website: Personalised/Loss, Personalised/Gain, Generalised/Loss and Generalised/Gain.
Control group
Active

Outcomes
Primary outcome [1] 321570 0
Behavioural intentions.

In line with published recommendations, behavioural intentions for physical activity and diet will be measured individually using three items: e.g. In the next month: (i) ‘I intend to exercise more’, (ii) ‘I expect to exercise more, (iii) ‘I will try to exercise more’. The items are rated on a 7-point scale ranging from (1) very unlikely to (7) very likely, and the average score will be used from the total of the 3 items.
Timepoint [1] 321570 0
Baseline and immediately after health risk communication intervention
Primary outcome [2] 321571 0
Type 2 diabetes risk perception.

Risk perception of Type 2 diabetes will be assessed using two items from the Risk Perception Survey for Developing Diabetes questionnaire (RPS-DD): (1) What do you think your risk or chance is for getting diabetes over the next 10 years?; and (2) If you don’t change your lifestyle behaviours, such as diet or exercise, what is your risk or chance of getting diabetes over the next 10 years?. Responses are scored on a Likert-type scale of 1 (almost no chance) to 4 (high chance). The scale is scored as the average of both items and a higher score is interpreted as a higher diabetes perceived risk.
Timepoint [2] 321571 0
Baseline and immediately after health risk communication intervention
Primary outcome [3] 327590 0
Accuracy of Type 2 Diabetes Risk. Dichotomous measures of accuracy will be created for T2D risk by comparing participants' actual and perceived T2D risk pre- and post-intervention. Participants will be considered to have either improve (i.e. inaccurate to accurate risk perception), stayed the same, or worsened (i.e. accurate to inaccurate risk perception).
Timepoint [3] 327590 0
Baseline and immediately after health risk communication intervention
Secondary outcome [1] 375404 0
Nil
Timepoint [1] 375404 0
Nil

Eligibility
Key inclusion criteria
(1) Currently not diagnosed with diabetes,
(2) Score at least an intermediate (<5 points) on the AUSDRISK, and
(3) only Australian and American (i.e USA) participants,
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Currently diagnosed with diabetes,
(2) Score low (4 points and below) on the AUSDRISK, and
(3) non-Australian and American (i.e USA) participants,

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by online Qualtrics system
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
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
Sample size: Using the program ‘G-Power’ (Faul, Erdfelder, Lang, & Buchner, 2007), a priori power analysis indicates that a sample size of 279 will be sufficient to attain a power of .95 to detect a medium effect size (f = .25).

Analyses: A 2x2 analysis of variance tests (ANOVAs) using General Linear Model (GLM) will be used to examine the main effects of message frames and the interaction effects on behavioural intentions. Effect sizes will be calculated using the means and SDs of each experimental group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/10/2019
Actual
2/12/2019
Date of last participant enrolment
Anticipated
Actual
2/01/2020
Date of last data collection
Anticipated
Actual
2/01/2020
Sample size
Target
279
Accrual to date
Final
347
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303959 0
University
Name [1] 303959 0
University of Wollongong
Country [1] 303959 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong NSW 2522, Australia
Country
Australia
Secondary sponsor category [1] 304129 0
None
Name [1] 304129 0
Address [1] 304129 0
Country [1] 304129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304459 0
UOW & ISLHD Social Sciences Human Research Ethics Committee
Ethics committee address [1] 304459 0
Northfields Ave Wollongong, NSW 2522 Australia
Ethics committee country [1] 304459 0
Australia
Date submitted for ethics approval [1] 304459 0
Approval date [1] 304459 0
06/08/2019
Ethics approval number [1] 304459 0

Summary
Brief summary
While health risk communication interventions have proved efficacious in the general population, it has not been adequately tested as a brief online intervention tool. The aim of this study is to assess the feasibility and efficacy of a brief online health risk communication intervention on changing behavioural intentions. Participants will be randomly assigned to receive a health risk communication intervention with either a personalised or generalised T2D risk presentation condition, and subsequently either a gain-framed or loss-framed health message condition (e.g. personalised risk and gain-framed health message, personalised risk and loss-framed health message etc). It is hypothesized that participants who received the personalised gained framed condition will demonstrate a greater change in their behavioural intentions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97018 0
A/Prof Peter Kelly
Address 97018 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong NSW 2522 Australia
Country 97018 0
Australia
Phone 97018 0
+61 2 4239 2382
Fax 97018 0
Email 97018 0
[email protected]
Contact person for public queries
Name 97019 0
A/Prof Peter Kelly
Address 97019 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong NSW 2522 Australia
Country 97019 0
Australia
Phone 97019 0
+61 2 4239 2382
Fax 97019 0
Email 97019 0
[email protected]
Contact person for scientific queries
Name 97020 0
A/Prof Peter Kelly
Address 97020 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong NSW 2522 Australia
Country 97020 0
Australia
Phone 97020 0
+61 2 4239 2382
Fax 97020 0
Email 97020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.