Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000112864
Ethics application status
Approved
Date submitted
3/12/2020
Date registered
4/02/2021
Date last updated
22/11/2021
Date data sharing statement initially provided
4/02/2021
Date results information initially provided
22/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an online diabetes risk communication intervention for people impacted by alcohol and other drugs: A randomized controlled trial
Scientific title
Impact of an online risk communication intervention on Type 2 diabetes risk in people impacted by alcohol and other drugs: A randomized controlled trial
Secondary ID [1] 302945 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
Trial Id: ACTRN12619001421123. The proposed trial is a subsequent study following the linked study record. Both studies are part of a PhD Dissertation.

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 319976 0
Drug and alcohol dependence 320259 0
Condition category
Condition code
Metabolic and Endocrine 317905 317905 0 0
Diabetes
Mental Health 317906 317906 0 0
Addiction
Public Health 317907 317907 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Online Type 2 Diabetes Risk Communication Intervention

The randomized controlled trial will replicate the procedures that have been used in a previous online study (linked study record). (1) Participants will be directed to the online survey (i.e. Qualtrics) to complete the study. Upon starting the survey, participants will have to give informed consent in order to proceed. (2) Participants will first undergo the screening phase by completing a series of questions pertaining to their demographics, drug and/or alcohol history and the Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK). Questions/questionnaires in the screening phase were compiled specifically for this study and will take approximately 5 minutes to complete. Participants who do not meet the eligibility requirements will be screened out of the survey. (3) Eligible participants will proceed on to the intervention phase and will be randomized to be in either the intervention or active control group. Participants in the intervention group will receive the personalized Type 2 diabetes risk message, while participants in the active control group will receive a COVID-19 health message. (4) Participants will complete a series of questions on risk perception and related-behavioural intentions pre- and post-intervention. (5) At the end of the survey, participants will be given the option to download their personalised Type 2 diabetes risk message and the COVID-19 health message. Participants will also be directed to a second survey to enter their email address to enter the lucky draw (10 x $50 visa gift cards).

Type 2 Diabetes Risk Message (Intervention): For this study, we will focus on the personalized/tailored manipulation, which had the most promising results (from the previous study), and compare it with an active control group. The message intervention consists of three sections: (1) T2D risk estimate and feedback, (2) general information on T2D, and (3) recommendations for lifestyle changes. Following the previous study, we have made some changes based on the needs of the AOD population i.e. provided a breakdown of AUSDRISK score so that participants can better comprehend their level of risk, additional graphics and videos to make the information more appealing and easier to understand. The personalized/tailored manipulation is specifically applied in Section 1, which provides participants with their individualized risk estimate. Each section will take approximately 2-3 minutes and overall it is estimated that participants will take no more than 10 minutes to read through the intervention.
- Section 1: Participants will receive an individualized tailored risk message which includes the AUSDRISK risk score, risk category, specific risk estimate (e.g. one person in every 50 will develop diabetes) in text and graphic.
- Section 2: Participants will receive a general fact sheet on T2D that discusses diabetes and its risk, risk factors and complications. This fact sheet is derived from publicly accessible information from the International Diabetes Federation and Diabetes Australia.
- Section 3: The lifestyle recommendation section is constructed using clinical guidelines for T2D prevention (The National Institute of Diabetes and Digestive and Kidney Diseases) that focused on the effects of health behaviour change. It includes general advice on making lifestyle changes to reduce the risk of T2D as well as specific steps to lower the risk (e.g. lose weight, get active, and eat healthy food).
Intervention code [1] 319230 0
Early detection / Screening
Intervention code [2] 319231 0
Prevention
Intervention code [3] 319232 0
Lifestyle
Comparator / control treatment
COVID-19 Active Control

The aim of the active control is to control for potential assessment effects and time reflecting on personal health. The message includes public accessible information (from the Australia Department of Health website) on COVID-19 and its symptoms, ways to stop the spread of the virus, people who are most at risk, how to seek medical attention, and taking care of one’s mental health. It is estimated that participants will take no more than 10 minutes to read through the COVID-19 health information provided.
Control group
Active

Outcomes
Primary outcome [1] 325921 0
Type 2 diabetes risk perception.

Consistent with previous studies, 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 [1] 325921 0
Pre- and post-intervention
Primary outcome [2] 325922 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 [2] 325922 0
Pre- and post-intervention
Primary outcome [3] 325923 0
Accuracy of Type 2 Diabetes Risk.

Dichotomous measures of accuracy will be created for Type 2 Diabetes (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). Actual risk will be calculated using the AUSDRISK while perceived risk will be calculated using the two items from the RPS-DD as stated above in Primary Outcome 1.

AUSDRISK: Participants' Type 2 Diabetes (T2D) risk will be examined using the Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK). It identifies individuals at high risk of developing T2D and consists of 11 items which assess demographic and diabetes risk factors. While the AUSDRISK was originally developed for an Australian sample population, the responses of ‘country of birth’ and ‘ethnicity’ have been modified (based on how specific race/ethnic groups have been defined in the USA) to fit a sample population in the USA.
Timepoint [3] 325923 0
Pre- and post-intervention
Secondary outcome [1] 389516 0
Perceived Risk of COVID-19.

Consistent with previous studies (Dryhurst et al., 2020), COVID-19 risk perception will be assessed using six-items that measure participants’ seriousness of the COVID-19 pandemic, perceived likelihood of contracting the virus themselves over the next 6 months, perceived likelihood of their family and friends catching the virus, and their present level of worry about the virus. Three items are measured on a 5 point likert scale with 1 being strongly disagree and 5 being strongly agree, while the other three items are measured on a 7 point likert scale with 1 being not at all likely and 7 being very likely.
Timepoint [1] 389516 0
Pre- and post-intervention
Secondary outcome [2] 389517 0
COVID-19 Preventive Behaviour Intentions.

Participant’s engagement of key COVID-19 protective behaviours, as identified in previous studies, will be measured. Participants will be asked how often they engage in (a) handwashing/sanitising, (b) physical distancing (i.e. staying 1.5-2m away from people) when outside, (c) going to work or outside despite having symptoms of COVID-19, and (d) wearing of mask. The items are rated on a 7-point scale ranging from (1) not at all to (7) as often as possible.
Timepoint [2] 389517 0
Pre- and post-intervention

Eligibility
Key inclusion criteria
This study involves a screening phase and intervention phase to maximise data collection. Specifically, this will allow us to understand the rates of diabetes among people with drug and alcohol problems. The inclusion criteria for the screening phase are:
- People aged 18 and above living in Australia or the United States of America (USA),
- have had problems with illicit drugs or alcohol and/or have attended alcohol or other drugs (AOD) treatment in the past 12 months

For participants to proceed on to the intervention phase, the inclusion criteria for participants are:
- do not have a diabetes diagnosis,
- score an intermediate or high risk on the Australian Type 2 Diabetes Risk Assessment Tool (AUSDRISK).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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


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: Exploratory analyses using factorial ANOVA’s will examine differences by drug type and gender. A two independent samples t-test will be used to test for any statistically significant differences between the means of behavioural intentions in the intervention and control group. A McNemar’s test will be used to examine for any significant differences in the proportion of people who more accurately assess their Type 2 diabetes risk at the end of the intervention. Tests will be two-tailed with p < 0.05. All analyses will be performed using Statistical Package for the Social Sciences (SPSS) Version 25.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/12/2020
Date of last participant enrolment
Anticipated
Actual
31/03/2021
Date of last data collection
Anticipated
Actual
31/03/2021
Sample size
Target
360
Accrual to date
Final
1282
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23272 0
United States of America
State/province [1] 23272 0

Funding & Sponsors
Funding source category [1] 307367 0
University
Name [1] 307367 0
University of Wollongong
Country [1] 307367 0
Australia
Primary sponsor type
University
Name
University of Wollongong
Address
Northfields Ave, Wollongong NSW 2522, Australia
Country
Australia
Secondary sponsor category [1] 308008 0
None
Name [1] 308008 0
Address [1] 308008 0
Country [1] 308008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307454 0
UOW & ISLHD Social Sciences Human Research Ethics Committee
Ethics committee address [1] 307454 0
Northfields Ave Wollongong, NSW 2522 Australia
Ethics committee country [1] 307454 0
Australia
Date submitted for ethics approval [1] 307454 0
04/12/2020
Approval date [1] 307454 0
16/12/2020
Ethics approval number [1] 307454 0
2019/183

Summary
Brief summary
Diabetes has been understudied in the substance use population and there have been strong calls to address this paucity. People with substance use problems are at high risk of developing T2D yet screening and education is not integrated into routine care. The aim of the proposed study is to assess the effectiveness of the T2D risk communication tool on T2D risk perceptions and behavioural intentions among people with alcohol or other drug problems (i.e. participants who are receiving treatment/support for substance use problems). Specifically, the study will examine whether personalised T2D risk feedback is more effective in improving risk perceptions and increasing health behavioural intentions to reduce T2D risk compared to an active control group. We hypothesise that participants receiving the personalised T2D risk feedback will report significantly more accurate T2D risk perceptions and greater behavioural intentions compared to participants in the active control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107290 0
A/Prof Peter Kelly
Address 107290 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong, Wollongong NSW 2522 Australia
Country 107290 0
Australia
Phone 107290 0
+61 2 4239 2382
Fax 107290 0
Email 107290 0
pkelly@uow.edu.au
Contact person for public queries
Name 107291 0
Peter Kelly
Address 107291 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong, Wollongong NSW 2522 Australia
Country 107291 0
Australia
Phone 107291 0
+61 2 4239 2382
Fax 107291 0
Email 107291 0
pkelly@uow.edu.au
Contact person for scientific queries
Name 107292 0
Peter Kelly
Address 107292 0
School of Psychology
Faculty of Social Sciences
Building 41, room 128
University of Wollongong, Wollongong NSW 2522 Australia
Country 107292 0
Australia
Phone 107292 0
+61 2 4239 2382
Fax 107292 0
Email 107292 0
pkelly@uow.edu.au

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.