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In the last decade, alcohol consumption among middle-aged women (40-65 years old) in Australia increased, despite declines in overall population consumption. Web-based, brief interventions are promising for reducing alcohol consumption, with efficacy shown in a wide range of populations. However, no published interventions have been designed specifically for and tested with middle-aged women.
This study aims to design and implement a web-based intervention intended to reduce alcohol consumption among middle-aged women.
The study is a 3-arm randomized controlled trial with a web-based intervention plus ecological momentary assessment (EMA) group compared to an EMA-only and a pre-post only control group. The study is aimed at middle-aged women, defined as women aged between 40 and 65 years, who consume alcohol at least weekly or who have consumed 4 or more drinks on 1 occasion in the last month. The intervention aims to reduce alcohol consumption through 4 modules that provide information on the health impacts of alcohol, mindfulness, social influences, and alcohol marketing. Intervention participants will also fill out biweekly EMA assessments. The comparators are EMA-only and pre-post control only. The primary outcome is alcohol consumption at 8 weeks compared between groups. Secondary outcomes are awareness of alcohol-related harms, readiness to change alcohol consumption, health status, mental health, and social support.
Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment has commenced, and the expected results will be available in 2022.
This web-based intervention aims to reduce alcohol consumption among middle-aged women, a currently understudied cohort in alcohol research.
Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000814976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000814976
DERR1-10.2196/34842
Historically, men have been larger consumers of alcohol than women, but recent evidence has shown a gender convergence in rates of alcohol consumption [
Several systematic reviews have been carried out to determine the overall efficacy of web-based interventions aimed at reducing alcohol consumption. The most recent, a review of systematic reviews [
There is a specific need for interventions designed by, and targeted at, middle-aged women for several reasons. Firstly, men and women have different patterns of alcohol use and different motives for consumption [
To our knowledge, there are no web-based interventions targeted specifically at middle-aged women that have been documented in the literature. Our study aims to fill this gap by developing and testing the effectiveness of a web-based intervention in reducing alcohol consumption among women aged 40-65 years. The primary aim of this study is to test the effectiveness of a 3-arm web-based intervention in reducing both the frequency of alcohol consumption as well as the alcohol intake per occasion among middle-aged women. Secondary aims include testing the effectiveness of the intervention in increasing awareness of the long- and short-term harms associated with alcohol consumption, increasing motivation to reduce alcohol consumption, reducing alcohol-related harm, improving reported health status and mental health, and increasing social support. We will also test reactivity to the ecological momentary assessment (EMA) by comparing a control group with weekly assessment to a pre-post control group.
We hypothesize that by the end of the intervention period, participants in the web-based intervention group will report significantly lower alcohol consumption compared with participants in the pre-post control group (H1).
We hypothesize that by the end of the intervention period, participants in the web-based 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); they will also display significant decreases in alcohol-related harm (H2e) when compared to the pre-post control only group.
We hypothesize that by the end of the intervention period, participants in the control group with weekly assessment will have greater reductions in alcohol consumption compared with participants in the pre-post control group (H3a). We further hypothesize that participants in the intervention group will report a greater reduction in alcohol consumption compared with participants in the control group with weekly assessment.
This study is a 3-arm randomized controlled trial including 1 intervention group, 1 pre-post control group and 1 control group with weekly assessment. The trial was registered with Australia New Zealand Clinical Trials Registry (ACTRN12620000814976) on August 14, 2020.
This study has received ethics approval from the La Trobe University Human Research Ethics Committee (HEC19938). Participants who are eligible for the intervention will be emailed a consent form with brief information about the study, prior to completing the baseline survey. Upon randomization, participants will complete a second short written consent form which will contain information specific to their intervention arm.
For this study, participants will be eligible if they are aged between 40 and 65 years, identify as female, reside in the Australian Capital Territory or a surrounding postcode that covers the Australian Capital Territory, are able to understand written English, are able to provide informed consent, own a mobile phone with SMS text messaging capabilities, have access to the internet, and consume alcohol at least weekly or consume 4 or more standard drinks at least once a month.
Women will be ineligible for the study if they are currently receiving treatment for a substance use disorder or are not in Australia for the duration of the study.
The effect sizes obtained in brief interventions, that is, change in the intervention group compared to the control group, are usually relatively small [
Recruitment will be carried out through a multipronged approach using both “online” and “offline” access points. Online recruitment will occur through media outlets such as Facebook, Twitter, websites, web-based newsletters, and magazines. Offline recruitment will include advertisements in school newsletters, local community group newsletters, general practitioner clinics, libraries, and gyms. Advertisements will include a link and QR code for a brief web-based screening questionnaire to assess participant eligibility.
We will undertake rolling recruitment, such that participants will be recruited continuously until 3000 individuals are participating in the study. Each participant will undertake the baseline assessment immediately after recruitment to ensure retention.
This study is a 3-arm randomized controlled trial of a web-based intervention to reduce alcohol consumption in middle-aged women.
Potential participants responding to an advertisement will be linked to the study website, which will provide them with a brief description of the study and an eligibility screener. Participants who are eligible will be electronically sent an initial consent form with brief information about the study and will be asked to complete the baseline survey. Participants who do not respond to the initial prompt to complete the baseline survey will be sent 3 reminders over 2 weeks. Upon completion of the baseline survey, participants will be randomized into 1 of 3 groups through the back-end platform specifically designed for the intervention, using a computer-generated number allocated to each participant. Participants will then complete a second short consent form that contains information specific to their intervention arm. As with most behavioral interventions, although it is not possible to blind participants to the procedures relating to their own group, they will not be aware of the procedures relating to the other groups. The researchers responsible for analysis will also be blinded. Only 1 member of the research team, who will be the contact point for any participants experiencing technical difficulties or presenting with queries, will be aware of participant allocation, if required to provide support.
The study will include 3 parallel conditions, of which all 3 will complete a baseline and follow-up questionnaire. The intervention design is shown in
Participants will be able to withdraw from the intervention at their request. If a participant reports an adverse event or complaint, they will be unblinded by matching their participant ID with the contact details database to enable us to establish contact and respond to any issues accordingly. A risk management database will be maintained where records of any issues will be logged.
To promote retention, all participants who complete the study (ie, complete the final assessment measures) will be entered into a draw to win 1 of 24 vouchers. There will be 12 AUD $50 vouchers, 9 AUD $100 vouchers, and 3 AUD $250 vouchers available (AUD $1=US $0.67). The large number of vouchers available reflects the repeated engagement required of participants as well as the intended large number of participants.
Intervention design. EMA: ecological momentary assessment; t: time point.
The underlying theory for this web-based intervention is based on the assumptions of the Integrated Behavioral Model. This model posits that the most important determinant of behavior is the intention to perform the behavior, informed by individuals’ attitudes, perceived norms, and personal agency [
Initially, participants will be surveyed on their alcohol use and provided with feedback on their current consumption, in line with brief intervention practice. Following this, participants will
To improve participants’ knowledge and skills to reduce their alcohol use, and to remove environmental constraints, each module will have between 1 and 3 associated
Participants will be sent reminders to complete their assessments, and upon completion of the assessment, will be redirected back to the intervention content. Participants can complete the intervention content in any order and will have the entire intervention period to access and work through all of the content.
At the conclusion of the trial, participant summaries will be developed and distributed to those participants who request one.
Participants in control group 1 will not be contacted again until the 8-week follow-up questionnaire. Participants in control group 2 (baseline and follow-up assessment plus EMA) will undertake the web-based repeated measures assessment of their alcohol consumption retrospectively twice a week. After they are recruited and randomized, these participants will be sent a link via text message to a web-based EMA. The assessment on Sunday at 12 PM will ask them about their drinking patterns over the weekend (ie, Thursday afternoon until Sunday morning), and the assessment on Thursday at 12 PM will ask about their drinking patterns during the week (ie, Sunday afternoon until Thursday morning). All participants in the control groups will be given access to the web-based intervention at the completion of the study.
The primary outcomes include frequency of alcohol consumption, as well as alcohol intake per drinking occasion. The secondary outcomes are awareness of alcohol-related harms, willingness to change alcohol consumption, alcohol-related harm, current health status, mental health, and social support or loneliness.
The following measures will be used, administered at baseline, EMA, and follow-up.
The baseline survey will assess a series of demographic characteristics, including educational level, country of birth, marital status, income, whether the participating women have children, the number of dependent children living in the household, employment status, as well as smoking status and frequency.
Participants will also be asked to report on how much they typically drink each day of the week (eg, “How many drinks containing alcohol do you consume on a typical Monday?”)
Frequency of binge drinking will be assessed by asking participants how often they have had 4 or more standard drinks (containing 10 grams of pure ethanol) on 1 drinking occasion over the last 12 months.
Participants’ daily alcohol consumption will be measured using a drinking diary, where twice a week they will retrospectively report on the number of beverages they consumed each day (eg, “Thinking back over the last three days, how many standard drinks containing alcohol did you have on each day of the week?”)
A total of 15 items from the Rutgers Alcohol Problem Index [
Two questions on pressures to drink have been adapted from the core questionnaire from the GenACIS project [
As no validated scale currently exists to measure awareness of alcohol harms, 2 questions will be taken from the scale used in the 2017 study by Coomber et al [
Drinking motives will be assessed using the Drinking Motives Questionnaire-Revised [
Readiness to change will be measured using the 12-item Readiness to Change Questionnaire [
Current level of stress will be measured using the 4-item Perceived Stress Scale [
Self-efficacy will be measured using the 10-item General Self-Efficacy Scale [
Relationship quality will be measured using the second item of the Relationship Assessment Scale [
Current health status will be measured using the first item of the General Health Questionnaire [
Mental health will be measured using the 5-item Mental Health Inventory [
Social support or loneliness will be measured using the 8-item UCLA Loneliness Scale-8 [
Five items from the Media and Technology Usage and Attitudes Scale [
The 8-item Client Satisfaction Questionnaire Adapted for Online Interventions [
The intervention’s back-end system will record the number of times participants log in to view the intervention content, and the time they spend on the website each time they log in. It will also record whether participants complete the requested number of follow-up EMAs. These data (number of visits, time spent on website, and number of EMAs completed) will be extracted from the system to assist in assessing the fidelity of the implementation of the intervention.
Participants will complete all assessments and access the intervention online; data will be stored on a secure server based in Australia. Access to the data will be password protected and limited to the members of the research team.
The reporting and presentation of this trial will be in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines for randomized controlled trials, and data on screening, refusals, and dropout will be coded and reported on per the guidelines [
All data that are collected will be analyzed using statistical software packages such as STATA (StataCorp) and Mplus (Muthén & Muthén). ANOVAs, contrasting the intervention groups against both control groups, will be run, and logistic and linear regression models will be used to determine potential influencing variables. Longitudinal analyses will be conducted to test group differences in EMA assessments over time.
Besides testing the main effects of the intervention, moderating effects of age, drinking status (whether participants are “risky” drinkers according to the Australian Alcohol Guidelines [
Ethics approval for this project was received on September 11, 2019. The trial was registered on August 14, 2020. Recruitment has commenced, and the expected results will be available in 2022.
This paper describes the study protocol of a randomized controlled trial to assess the benefit of a targeted web-based intervention to reduce alcohol consumption among middle-aged women. Intervention with this group is imperative because their alcohol consumption has increased at a time when that of other groups has remained stable or declined [
Most web-based interventions aimed at reducing alcohol consumption have been designed for the general adult population, youth, or pregnant women. This study will be, to our knowledge, the first web-based intervention designed by and tested on middle-aged women. Additionally, the use of repeated-measured assessment (EMA) will allow us to gain rich data on participants’ alcohol consumption over an 8-week period, which is a strength. Further, the use of 2 control groups (1 with EMA and 1 without) will enable us to assess the true effect of the intervention, as well as determine whether EMAs alone may result in reduced alcohol consumption. As with most alcohol research, the reliance on self-report data can lead to reporting bias; however, it is not anticipated that this bias will differ among the 3 groups. The intervention will only be tested initially on women residing in 1 Australian state, so generalizability may be limited in the first instance.
Screenshots of intervention.
Consolidated Standards of Reporting Trials
ecological momentary assessment
We acknowledge the contribution of the Foundation for Alcohol Research and Education (FARE) and greatly thank the women who participated in our focus groups.
The study is supported by a subcontract with FARE based on a collaboration between the Centre for Alcohol Policy Research (CAPR) and FARE funded by a grant from Australian Capital Territory Health under the Health Promotion Grants Program (HCG18/19 - 20/21_055). The funding source had no role in the study design, collection, analysis, or interpretation of the data, writing the manuscript, or the decision to submit the paper for publication.
The data generated and analyzed during the study are not publicly available due to privacy issues but are available from the corresponding author on reasonable request.
EK and SK conceived the original concept of the study. All authors contributed to the design of the intervention and trial. MM drafted the manuscript. All authors provided comments on the draft and read and approved the final manuscript.
None declared.