Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000814976
Ethics application status
Approved
Date submitted
21/05/2020
Date registered
14/08/2020
Date last updated
14/08/2020
Date data sharing statement initially provided
14/08/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing the Booming Booze Culture in Middle-Aged Women: Effect of an Online Intervention on Alcohol Consumption
Scientific title
Addressing the Booming Booze Culture in Middle-Aged Women: Effect of an Online Intervention on Alcohol Consumption
Secondary ID [1] 298070 0
Nil
Universal Trial Number (UTN)
U1111-1232-3848
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Consumption 312566 0
Condition category
Condition code
Public Health 311083 311083 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The underlying theory for the present online intervention is based on the assumptions of the Integrated Behavioural Model (Fishbein, 2000) and the Transtheoretical Model of Change (Prochaska, 1979). The Integrated Behavioural Model (Fishbein, 2000) posits that the most important determinant of behaviour is the intention to perform the behaviour, informed by individuals’ attitudes, perceived norms and personal agency. However, within this model, intention to perform a behaviour is modified by four key factors: knowledge and skills, environmental constraints; the salience of the behaviour to the individual and the role of habits.
The Transtheoretical Model of Change (Prochaska, 1979) provides an integrative framework for understanding and intervening with human intentional behaviour change. The theory posits that individuals move through six stages of change, and for each stage, different behavioural change strategies will be effective. The intervention operationalises principles from both theories and integrates concepts from the alcohol-specific behavioural literature to develop a comprehensive approach to changing alcohol consumption. The intervention is also based on the outcomes of interactive focus group workshops that were run by the research team with women aged 40-65.

The core features of the intervention include: (1) Goal setting: Enabling participants to set goals at the start of the intervention period, and amend throughout, for the reduction of their alcohol consumption; (2) Tracking of alcohol consumption: Based on the data collected in their twice-weekly assessments, participants will see a live graph of their alcohol consumption which will update after each assessment is completed; (3) Four modules of content: (a) The Low-Risk Drinking Module, which will provide the most up to date evidence of the harms associated with alcohol consumption, information about what a standard drink is, an online calculator that will allow participants to measure their current level of consumption and receive feedback on the associated costs and harms; (b) The Mindful Drinking module which will contain information about drinking motives, and provide participants with skills to both learn to consume alcohol mindfully, as well as apply the broader technique of mindfulness to their lives to reduce the common antecedents of alcohol consumption (such as stress); (c) The Social Drinker module, will explore the social influences on drinking, including facts about how people influence each other both consciously and unconsciously, encourage participants to reflect on where alcohol currently fits into their social lives, and help build participant’s skills to talk about their alcohol consumption with others, and (d) the Alcohol is Everywhere module, which will look at the broader factors that influence alcohol consumption, including information about the normativity of alcohol in Australian society and how alcohol availability and outlet density impact on consumption, the ways in which the alcohol industry specifically target women, how alcohol advertising impacts on children, and the broader alcohol industry tactics used to promote their products; and (4) Challenges associated with each module: One to two challenges will be available at the end of each module, allowing participants to operationalise their learnings in the real world.

Participants in the intervention group will have six weeks to complete the modules, which they can access and complete in any order.

The interventions back-end system will record the number of times in which participants log on to view the intervention content, and the time they spend on the website each time they login. It will also record whether participants complete the requested number of follow-up Ecological Momentary Assessments (EMA). This data (number of visits, time spent on website, number of EMA’s completed) will be extracted from the system to assist in assessing the fidelity of the implementation of the intervention.
Intervention code [1] 314301 0
Lifestyle
Intervention code [2] 317753 0
Behaviour
Comparator / control treatment
Participants in control group 1 will not be contacted at all until the 8-week follow-up questionnaire. All participants will be given access to the online intervention at the completion of the study.
Participants in control group 2 (EMA-only) will only undertake the online repeated measures assessment of their alcohol consumption retrospectively once a week. After they are recruited and randomised, participants will be sent a link via text message to an online EMA twice a week. The assessment on Sunday at 12pm will ask them about their drinking patterns over the weekend (i.e. Thursday afternoon until Sunday morning, and the assessment on Thursday at 12pm will ask about their drinking patterns during the week (i.e. Sunday afternoon until Thursday morning).
Control group
Active

Outcomes
Primary outcome [1] 319866 0
The primary outcome is alcohol consumption. This will be measured through self-report via an online questionnaire, adapted from the Quantity-Frequency (QF) method. The data collected will be on the frequency of alcohol consumption (i.e. how many days a week they consume alcohol), as well as their alcohol intake per drinking occasion which will be combined to form the variable.
Timepoint [1] 319866 0
At baseline, in the weekly EMAs and at the 8-week follow up
Secondary outcome [1] 369745 0
Awareness of long-term alcohol harms, as measured using an online self-report survey designed specifically for this study.
Timepoint [1] 369745 0
At baseline, and at the 8-week follow up.
Secondary outcome [2] 372422 0
Motivation to reduce alcohol consumption, as measured using the Readiness to Change questionnaire administered through an online survey.
Timepoint [2] 372422 0
At baseline, and at the 8-week follow up.
Secondary outcome [3] 383558 0
Alcohol-related harm, as measured using 15 items from the Rutgers Alcohol Problem Index and the Young Adults Alcohol Consequences Questionnaire (YAACQ), administered through an online survey
Timepoint [3] 383558 0
At baseline, and at the 8-week follow up
Secondary outcome [4] 383560 0
Current Health Status, as measured using the first item of the General Health Questionnaire administered through an online survey
Timepoint [4] 383560 0
At baseline and at the 8-week follow up
Secondary outcome [5] 383561 0
Social support/loneliness will be measured using the eight-item UCLA Loneliness Scale, administered through an online survey
Timepoint [5] 383561 0
At baseline, in the weekly EMAs and at the 8-week follow up
Secondary outcome [6] 383562 0
Mental health, as measured using the five item Mental Health Inventory (MHI-5) administered through an online survey.
Timepoint [6] 383562 0
At baseline and at the 8-week follow up

Eligibility
Key inclusion criteria
• Identify as female; and
• Aged between 40 and 65 years; and
• Able to provide informed consent; and
• Reside in the ACT or a surrounding postcode which covers the ACT; and
• Possess fluency in English; and
• Have access to the internet; and
• Own a mobile phone with SMS capabilities; and
• Consume alcohol at least weekly; OR
• Consume four or more standard drinks at least once a month
Minimum age
40 Years
Maximum age
65 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Currently receiving treatment for a substance use disorder
• Not in Australia for the duration of the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be achieved by performing the randomisation after participants have completed the baseline assessments and been deemed eligible for the study. Randomisation will be conducted independently of the study team. The back-end platform designed for this intervention will automatically randomly allocate participants to either of the three groups using computer-generated numbers.
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 assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The reporting and presentation of this trial will be in accordance with the CONSORT guidelines for randomised trials and data on screening, refusals and dropout will be coded and reported on as per the guidelines (Schulz, Altman & Moher, 2010). The comparative analysis will be analysed in accordance with the intention-to treat principle and the completers-only framework. Missing data will be handled accordingly; the intention-to-treat analyses multiple imputation methods will be used, while completers-only analyses will be conducted on participants providing scores for all measurements.
All data that is collected will be analysed using Excel and statistical software packages such as STATA and Mplus. We will use logistic and linear regressions for both sets of analyses to test intervention effects on our primary and secondary outcomes. Regressions will use the two control groups 1 (pre-post measure) and 2 (EMA only) separately as comparison groups to the intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2020
Actual
Date of last participant enrolment
Anticipated
2/04/2021
Actual
Date of last data collection
Anticipated
2/04/2021
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 303241 0
Government body
Name [1] 303241 0
ACT Health
Country [1] 303241 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 306329 0
None
Name [1] 306329 0
Address [1] 306329 0
Country [1] 306329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303236 0
La Trobe University Human Research Ethics Committee
Ethics committee address [1] 303236 0
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Ethics committee country [1] 303236 0
Australia
Date submitted for ethics approval [1] 303236 0
16/07/2019
Approval date [1] 303236 0
11/09/2019
Ethics approval number [1] 303236 0
HEC19338

Summary
Brief summary
This study is a three-arm randomised control trial of an online intervention to reduce alcohol consumption in middle-aged women. The underlying theory for the intervention is based on the assumptions of the Integrated Behavioural Model (Fishbein, 2000) and the Transtheoretical Model of Change (Prochaska, 1979). Participants in the intervention will have access to core features that include goal setting, tracking of alcohol consumption, four modules of content, and associated challenges to operationalise their learnings. Participants will also complete Ecological Momentary Assessments (EMA) to record their alcohol consumption twice weekly over a 6-week period. We hypothesise that by the end of the intervention, participants in the online intervention group will report a significantly lower alcohol consumption than participants of the control group without weekly assessment (H1a).

We also hypothesise that by the of the intervention period, participants in the online intervention group will display significant increases in; their awareness of harms associated with alcohol consumption (H2a), their motivation to reduce their alcohol consumption (H2b), social support (H2c),and current health status (H2d); and significant decreases in alcohol-related harm (H2e) and current level of stress (H2f), when compared to the control group without weekly assessment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92954 0
Dr Sandra Kuntsche
Address 92954 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 92954 0
Australia
Phone 92954 0
+61 03 9479 8770
Fax 92954 0
Email 92954 0
[email protected]
Contact person for public queries
Name 92955 0
Dr Sandra Kuntsche
Address 92955 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 92955 0
Australia
Phone 92955 0
+61 03 9479 8770
Fax 92955 0
Email 92955 0
[email protected]
Contact person for scientific queries
Name 92956 0
Dr Sandra Kuntsche
Address 92956 0
La Trobe University
Plenty Rd & Kingsbury Dr, Bundoora VIC 3086
Country 92956 0
Australia
Phone 92956 0
+61 03 9479 8770
Fax 92956 0
Email 92956 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
The IPD will not be shared due to ethical and privacy concerns.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8750Study protocol    Protocol will be made available once published



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.