An interventional study of Brief alcohol intervention (Health4Her-Automated) and Lifestyle health promotion in Health Knowledge, Attitudes, Practice and Alcohol Drinking, sponsored by Turning Point. Completed at 1 site in Australia. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Turning Point · Not applicable, Interventional, and Other
Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this risk remains surprisingly low and is not systematically addressed in healthcare settings. This study aim to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.
Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts. In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and is not systematically addressed in healthcare settings. Embedding a brief alcohol intervention within lifestyle information offered to all women attending breast screening provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to prevent alcohol-attributable breast cancer among this at-risk population.
Brief alcohol interventions are short, single-session programs typically offered in general practice settings to gather information on a person's alcohol consumption and, in a non confrontational way, provide strategies and motivate change to reduce consumption and related risk of harm. An automated brief alcohol intervention, self-completed on a device such as an iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of providing intervention within busy healthcare environments.
Building on the previous pilot trial of a prototype brief e-health intervention (which included alcohol-related questions asked by a researcher, and an animation viewed on an iPad that was activated by the researcher), the aim of the current study is to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's enrollment of 143 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →Turning Point is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The intervention arm will receive: * brief alcohol intervention * lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk. Participants will receive an iPad and earphones to self-complete the intervention. Alcohol and lifestyle information will be delivered by way of an animation on an iPad, and self-completed activities to reinforce intervention content.
Behavioral: Brief alcohol intervention (Health4Her-Automated) · Behavioral: Lifestyle health promotion
The control arm will receive: * lifestyle health promotion focused on physical activity and maintaining a healthy weight for reducing breast cancer risk. Participants will receive an iPad and earphones to self-complete the control intervention. Lifestyle information will be delivered by way of an animation on an iPad, and a self-completed activity to reinforce intervention content.
Behavioral: Lifestyle health promotion
Embedded within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive a brief alcohol intervention. The brief alcohol intervention will comprise information and behaviour-change content regarding alcohol consumption, including: messaging around alcohol risks/harms (with a focus on alcohol use and breast cancer risk), positive-framed messaging on the health benefits of reducing alcohol intake, and alcohol harm-reduction / behaviour change strategies (e.g. drink counting, goal setting, behaviour substitution, problem solving). Post-session information will be provided via email (i.e. electronic brochure summarising brief alcohol intervention content).
Lifestyle health promotion, focused on physical activity and maintaining a healthy weight for reducing breast cancer risk, will be provided. Post-session information will be provided via email (i.e. electronic brochure summarising nutrition for maintaining a healthy weight).
Drinking intentions
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Time frame: immediately post-randomisation
Drinking intentions
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Time frame: 4-weeks post-randomisation
Drinking intentions - standard drinks
Change in intended number of standard drinks consumed over the next month (composite of intention frequency/quantity response items)
Time frame: 4-weeks post-randomisation
Proportion of participants intending to reduce alcohol consumption
Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
Time frame: immediately post-randomisation
Proportion of participants intending to reduce alcohol consumption
Proportion of participants intending to reduce their next-month alcohol consumption (5-point scale: 1, not at all; 5, to a very large extent)
Time frame: 4-weeks post-randomisation
Knowledge of alcohol as a breast cancer risk factor
Proportion of participants accurately identifying alcohol as a clear risk factor for breast cancer
Time frame: 4-weeks post-randomisation
Alcohol literacy
Proportion of participants accurately identifying i) the increased breast cancer risk associated with drinking one average restaurant serve of wine a day; ii) the number of standard drinks in an average restaurant serve of red wine; iii) the maximum number of standard drinks per week recommended by current Australian Alcohol Guidelines (multiple-choice questions)
Time frame: 4-weeks post-randomisation
Alcohol consumption
Among women who have had an alcohol drink in the past month, change in alcohol consumption (composite of frequency/quantity response items)
Time frame: 4-weeks post-randomisation
Knowledge of other breast cancer risk factors
Proportion of participants accurately identifying inactivity and excess weight as risk factors for breast cancer
Time frame: 4-weeks post-randomisation
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Plan to share: No — There is not Ethics approval to seek patient permission to share data outside this study.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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