Health Knowledge, Attitudes, PracticeNCT06019442
An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)
A study testing Brief alcohol intervention (Health4Her-Automated) and Lifestyle health promotion in people with Health Knowledge, Attitudes, Practice and Alcohol Drinking, run by Turning Point at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Alcohol Drinking
- What is being tested?
- Brief alcohol intervention (Health4Her-Automated) and Lifestyle health promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 40+ years of age
- Attending routine breast screening
- With or without a breast cancer history
- Reporting any level of alcohol consumption
Who cannot join
- Not able to read or comprehend English to enable participation
- No access to a computer, tablet or smartphone to complete follow-up assessment
- Women who are pregnant (also an exclusion from breast screening)
- Participation in the pilot Health4Her trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial
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.
Read the detailed description
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.
- Being tested
- Brief alcohol intervention (Health4Her-Automated), Lifestyle health promotion
- Keywords
- Women's health, Public health, Health promotion
- Medical subject headings
- Behavior, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief alcohol intervention (Health4Her-Automated)Behavioural
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 promotionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion | Experimental | 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. Receives: Behavioral: Brief alcohol intervention (Health4Her-Automated); Behavioral: Lifestyle health promotion |
| Lifestyle health promotion | Other | 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. Receives: Behavioral: Lifestyle health promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking intentions
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Measured: immediately post-randomisation
Secondary outcomes (8)
Drinking intentions
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 4-weeks post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023
- Primary completion6 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial (2 arms) + pilot of modified active arm The pilot group does not form part of the planned randomised controlled trial or power and sample size calculation, but is included based on findings from the previous phase of this research (e.g. women not having time to complete the intervention onsite). Therefore n\~20 women who cannot participate on the day of breast screening will be offered to participate in the modified active arm offsite.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turning Point
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University, Eastern Health, BreastScreen Victoria, Lifepool, Shades of Pink
- Responsible party
- Sponsor
- Investigators
- Jasmin Grigg, PhD, Principal investigator, Turning Point, Eastern Health; Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019442
- Sponsor's protocol ID
- LR22-071-91112
- Status last verified
- Dec 2023
- First submitted
- 13 Aug 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not Ethics approval to seek patient permission to share data outside this study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Brief Intervention to Reduce Alcohol Consumption Intentions, Improve Alcohol Literacy, and Reduce Harmful Use Among Women Attending a Breast Screening Service: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06019442
- Acronym / sponsor ID
- LR22-071-91112
- Keywords
- Women's health, Public health, Health promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Turning PointUniversity, hospital or other
- Collaborators
- Monash University, Eastern Health, BreastScreen Victoria, Lifepool, Shades of Pink
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial (2 arms) + pilot of modified active arm The pilot group does not form part of the planned randomised controlled trial or power and sample size calculation, but is included based on findings from the previous phase of this research (e.g. women not having time to complete the intervention onsite). Therefore n~20 women who cannot participate on the day of breast screening will be offered to participate in the modified active arm offsite.
| Arm | Type | Receives |
|---|---|---|
| Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion | Experimental | Behavioral: Brief alcohol intervention (Health4Her-Automated), Behavioral: Lifestyle health promotionThe 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. |
| Lifestyle health promotion | Other | Behavioral: Lifestyle health promotionThe 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- 40+ years of age
- Attending routine breast screening
- With or without a breast cancer history
- Reporting any level of alcohol consumption
Key exclusion criteria (4 listed)
- Not able to read or comprehend English to enable participation
- No access to a computer, tablet or smartphone to complete follow-up assessment
- Women who are pregnant (also an exclusion from breast screening)
- Participation in the pilot Health4Her trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief alcohol intervention (Health4Her-Automated)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). | Behavioural | Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion |
| Lifestyle health promotionLifestyle 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). | Behavioural | Brief alcohol intervention (Health4Her-Automated) + lifestyle health promotion, Lifestyle health promotion |
Primary outcome
Drinking intentions
Time frame: immediately post-randomisation
Change in next-month drinking intentions (5-point scale: 1, not at all; 5, to a very large extent)
8 secondary outcomes
Drinking intentions
Time frame: 4-weeks post-randomisation
Drinking intentions - standard drinks
Time frame: 4-weeks post-randomisation
Proportion of participants intending to reduce alcohol consumption
Time frame: immediately post-randomisation
Proportion of participants intending to reduce alcohol consumption
Time frame: 4-weeks post-randomisation
Knowledge of alcohol as a breast cancer risk factor
Time frame: 4-weeks post-randomisation
Alcohol literacy
Time frame: 4-weeks post-randomisation
Alcohol consumption
Time frame: 4-weeks post-randomisation
Knowledge of other breast cancer risk factors
Time frame: 4-weeks post-randomisation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No. There is not Ethics approval to seek patient permission to share data outside this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasmin Grigg, PhD principal investigator
Turning Point, Eastern Health; Monash University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief alcohol intervention (Health4Her-Automated) and Lifestyle health promotion in people with Health Knowledge, Attitudes, Practice and Alcohol Drinking, run by Turning Point at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking intentions (time frame: immediately post-randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.