Alcohol MisuseNCT04025151
Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students
A study testing Alcohol brief intervention, 12-page health warning leaflet and Regular messages through Instant Messaging (IM) in people with Alcohol Misuse, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Misuse
- What is being tested?
- Alcohol brief intervention, 12-page health warning leaflet and Regular messages through Instant Messaging (IM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 770 participants
- Where
- 1 siteHong Kong
- Study dates
- 30 Sep 2020to 30 Nov 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Student aged ≥18 years from local universities in Hong Kong
- Able to read and communicate in Chinese (Cantonese or Mandarin)
- Likely to stay in Hong Kong for most of the time in the next 12 months
- Using IM Apps (WhatsApp or WeChat) installed on a smartphone
- Baseline AUDIT screening score ≥8
Who cannot join
- Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Currently participating in treatments or programmes on reducing alcohol use
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing, The University of Hong Kong
Hong Kong, 000000
Siu Long Chau, PhD, +852-39176981, h1357885@connect.hku.hk
About this study
Official title: Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial
This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.
Read the detailed description
The government has promoted Hong Kong as the Asian's wine hub with zero alcohol tax (ethanol ≤30%) since 2008, which causes dramatic increases in alcohol drinking and binge drinking rates. Alcohol use in youth is the leading cause of disability adjusted life-years loss. Most adult drinkers start drinking at age 18-21. Evidence shows that alcohol brief intervention (ABI) is effective reducing hazardous and harmful alcohol use in university students. The proposed trial aims to enhance the ABI by incorporating information communication technologies (ICTs) such as instant messaging (IM) Apps (e.g. WhatsApp and WeChat) to provide personalized, real-time chat-based support led by nurses. The aims of study are as follows:
- To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary)
- To assess the effects on alcohol consumption per week at 12-month, AUDIT scores at 6 and 12-month, perceived usefulness of IM app at 12-month, intention to use IM app to reduce/quit drinking at 12-month, number of standard drinks, episode of binge drinking, episode of heavy drinking, planned drinking, Academic Role Expectation and Alcohol Scale, Alcohol Problems Scale, Patient Health Questionnaire 4-item, Perceived Stress Scale 4-item, Covid-19 related drinking behavioral changes, and self-efficacy to reduce/quit drinking at 6-month and 12-month
- To identify mediators between intervention and outcomes to inform the potential mechanisms
- To qualitatively explore experience on the interventions for reducing alcohol use and related harms
- Conditions
- Alcohol Misuse
- Being tested
- Alcohol brief intervention, 12-page health warning leaflet, Regular messages through Instant Messaging (IM), Real-time chat-based support through IM Apps, General health through SMS
- Keywords
- chat-based IM, alcohol brief intervention, alcohol misuse, university students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol brief interventionBehavioural
At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes
12-page health warning leafletBehavioural
Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.
Regular messages through Instant Messaging (IM)Behavioural
A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests.
Real-time chat-based support through IM AppsBehavioural
The chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption.
General health through SMSBehavioural
After baseline, they will receive regular e-message through SMS with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.
AUDIT score interpretation sheet adapted from the Department of Health of Hong KongBehavioural
a diagram explaining drinking behaviour and potential health risks, definitions of "alcohol unit" and "binge drinking", and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps Receives: Behavioral: Alcohol brief intervention; Behavioral: 12-page health warning leaflet; Behavioral: Regular messages through Instant Messaging (IM); Behavioral: Real-time chat-based support through IM Apps; Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong |
| control group | Active comparator | Alcohol brief intervention, leaflets, regular messages on general health through SMS Receives: Behavioral: Alcohol brief intervention; Behavioral: 12-page health warning leaflet; Behavioral: General health through SMS; Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of alcohol consumption per week (gram/week) at 6-month follow-up
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline.
Measured: 6-month after baseline
Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis
To estimate large, moderate and null (same as the control) treatment effects and check whether ITT, AP and PP analysis estimates are biased compared with CACE estimates (alcohol consumption per week at 6-month follow-up)
Measured: 6-month after baseline
Secondary outcomes (29)
Amount of alcohol consumption per week (gram/week) at 12-month follow-up
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.
Measured: 12-month after baseline
AUDIT scores at 6-month follow-up
Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 6-month after baseline.
Measured: 6-month after baseline
AUDIT scores at 12-month follow-up
Assessed by Alcohol Use Disorders Identification Test (ranged 0-40 with higher score indicating problematic alcohol use) and compare the AUDIT between intervention and control group at 12-month after baseline.
Measured: 12-month after baseline
Number of standard drinks (10g of alcohol) per week at 6-month follow-up
Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month
Measured: 6-month after baseline
Number of standard drinks (10g of alcohol) per week at 12-month follow-up
Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month
Measured: 12-month after baseline
Episode of binge drinking in the past 30-day at 6-month follow up
Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Episode of binge drinking in the past 30-day at 12-month follow up
Defined by 5 standard drink [male] or 4 standard drink [female] in one occasion for binge drinking and compare the episode of binge drinking between intervention group and control at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Episode of heavy drinking in the past 30-day at 6-month follow up
Defined by 15 standard drink [male] or 8 standard drink[female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 6-month follow-up questionnaires
Measured: at 6 -month after baseline
Episode of heavy drinking in the past 30-day at 12-month follow up
Defined by 15 standard drink [male] or 8 standard drink [female] in a week for heavy drinking and compare the episode of heavy drinking between intervention group and control at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Planned drinking measured in the coming 30-day at 6-month follow up
Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Planned drinking measured in the coming 30-day at 12-month follow up
Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Academic Role Expectation and Alcohol Scale at 6-month follow-up
The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Academic Role Expectation and Alcohol Scale at 12-month follow-up
The four items in this scale addressed the number of times the student had been 'late to class', 'missed class', was 'unable to concentrate' and 'failed to complete assignment' (score range 0-16). The responses included 'not at all', 'once', 'twice', 'three times' and 'four times or more'. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Alcohol Problems Scale at 6-month follow-up
The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Alcohol Problems Scale at 12-month follow-up
The 14-item measure of alcohol-related personal, social, sexual, and legal problems (eg, being physically aggressive toward someone while under the influence of alcohol).The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12- month after baseline
Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month
Mediation analysis of 6-month factors (knowledge of alcohol drinking, perception of alcohol drinking, intention to quit drinking, mental health) on weekly amount of alcohol consumption at 12-month
Measured: at 12- month after baseline
Subgroup analysis of baseline intention to quit/reduce drinking
Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes
Measured: at 12- month after baseline
Content analysis of IM Apps conversation using alcohol BCT taxonomy
The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy
Measured: at 12- month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 6-month
Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 12-month
Total score is determined by adding together the scores of each of the 4 items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 6-month
Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2
=sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress.
The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 12-month
Subjects' responses are measured on a five-point scale (0 = never, 1 = almost never, 2
=sometimes, 3 = fairly often, 4 = very often). Scoring: PSS-4 scores are obtained by summing across all four items. Scoring items 2 and 3 require reverse coding. This involves assigning the opposite score. For example, a score of 0=4, 1=3, 2=2, 3=1, and 4=0. The higher the score, the more perceived stress.
The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Perceived usefulness of IM app intervention at 12-month
Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.
Measured: at 12-month after baseline
Intention to continue using IM app intervention at 12-month
Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month
Measured: at 12-month after baseline
Self-efficacy to reduce/quit drinking at 6-month
Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked.
Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 6-month follow-up questionnaires
Measured: at 6-month after baseline
Self-efficacy to reduce/quit drinking at 12-month
Perceived difficulty, confidence and importance of quitting/reducing to drink will be asked.
Score ranges from 0 to 10 with higher score indicates a high level. The score will be compared between intervention group and control group at baseline and 12-month follow-up questionnaires
Measured: at 12-month after baseline
Covid-19 related drinking behavioral changes at baseline
Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic
Measured: at baseline
Covid-19 related drinking behavioral changes at 6-month
Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 6-month
Measured: at 6-month
Covid-19 related drinking behavioral changes at 12-month
Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic. The changes will be compared between the intervention group and control group at 12-month
Measured: at 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start30 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Alcohol MisuseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 770 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wang Man-Ping, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025151
- Sponsor's protocol ID
- Chat-based ABI (UniStudents)
- Status last verified
- Sep 2021
- First submitted
- 16 Jul 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thomas GN, Wang MP, Ho SY, Mak KH, Cheng KK, Lam TH. Adverse lifestyle leads to an annual excess of 2 million deaths in China. PLoS One. 2014 Feb 26;9(2):e89650. doi: 10.1371/journal.pone.0089650. eCollection 2014.
PubMed 24586936Gore FM, Bloem PJ, Patton GC, Ferguson J, Joseph V, Coffey C, Sawyer SM, Mathers CD. Global burden of disease in young people aged 10-24 years: a systematic analysis. Lancet. 2011 Jun 18;377(9783):2093-102. doi: 10.1016/S0140-6736(11)60512-6. Epub 2011 Jun 7.
PubMed 21652063Wang MP, Ho SY, Lam TH. Underage alcohol drinking and medical services use in Hong Kong: a cross-sectional study. BMJ Open. 2013 May 28;3(5):e002740. doi: 10.1136/bmjopen-2013-002740.
PubMed 23793697Huang R, Ho SY, Wang MP, Lo WS, Lam TH. Reported alcohol drinking and mental health problems in Hong Kong Chinese adolescents. Drug Alcohol Depend. 2016 Jul 1;164:47-54. doi: 10.1016/j.drugalcdep.2016.04.028. Epub 2016 Apr 25.
PubMed 27177803Department of Health. Report of population health survey 2014/15, Hong Kong SAR; 2018. Retrived at 24 Oct 2018 from: https://www.chp.gov.hk/en/static/51256.html
Kaner EF, Beyer FR, Muirhead C, Campbell F, Pienaar ED, Bertholet N, Daeppen JB, Saunders JB, Burnand B. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev. 2018 Feb 24;2(2):CD004148. doi: 10.1002/14651858.CD004148.pub4.
PubMed 29476653Fachini A, Aliane PP, Martinez EZ, Furtado EF. Efficacy of brief alcohol screening intervention for college students (BASICS): a meta-analysis of randomized controlled trials. Subst Abuse Treat Prev Policy. 2012 Sep 12;7:40. doi: 10.1186/1747-597X-7-40.
PubMed 22967716Kaner EF, Beyer FR, Garnett C, Crane D, Brown J, Muirhead C, Redmore J, O'Donnell A, Newham JJ, de Vocht F, Hickman M, Brown H, Maniatopoulos G, Michie S. Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations. Cochrane Database Syst Rev. 2017 Sep 25;9(9):CD011479. doi: 10.1002/14651858.CD011479.pub2.
PubMed 28944453Larimer ME, Cronce JM, Lee CM, Kilmer JR. Brief intervention in college settings. Alcohol Res Health. 2004-2005;28(2):94-104.
PubMed 19006997Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for alcohol problems: a meta-analytic review of controlled investigations in treatment-seeking and non-treatment-seeking populations. Addiction. 2002 Mar;97(3):279-92. doi: 10.1046/j.1360-0443.2002.00018.x.
PubMed 11964101Fowler LA, Holt SL, Joshi D. Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. Addict Behav. 2016 Nov;62:25-34. doi: 10.1016/j.addbeh.2016.06.008. Epub 2016 Jun 7.
PubMed 27310031Kypri K, Hallett J, Howat P, McManus A, Maycock B, Bowe S, Horton NJ. Randomized controlled trial of proactive web-based alcohol screening and brief intervention for university students. Arch Intern Med. 2009 Sep 14;169(16):1508-14. doi: 10.1001/archinternmed.2009.249.
PubMed 19752409Kypri K, Vater T, Bowe SJ, Saunders JB, Cunningham JA, Horton NJ, McCambridge J. Web-based alcohol screening and brief intervention for university students: a randomized trial. JAMA. 2014 Mar 26;311(12):1218-24. doi: 10.1001/jama.2014.2138.
PubMed 24668103Hoermann S, McCabe KL, Milne DN, Calvo RA. Application of Synchronous Text-Based Dialogue Systems in Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Jul 21;19(8):e267. doi: 10.2196/jmir.7023.
PubMed 28784594Luk TT, Li WHC, Cheung DYT, Wong SW, Kwong ACS, Lai VWY, Chan SS, Lam TH, Wang MP. Chat-based instant messaging support combined with brief smoking cessation interventions for Chinese community smokers in Hong Kong: Rationale and study protocol for a pragmatic, cluster-randomized controlled trial. Contemp Clin Trials. 2019 Feb;77:70-75. doi: 10.1016/j.cct.2018.12.013. Epub 2018 Dec 26.
PubMed 30593882
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students: a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04025151
- Acronym / sponsor ID
- Chat-based ABI (UniStudents)
- Conditions
- Alcohol Misuse
- Keywords
- chat-based IM, alcohol brief intervention, alcohol misuse, university students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 770 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 18 Jul 2019 (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.
This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.
Detailed description
The government has promoted Hong Kong as the Asian's wine hub with zero alcohol tax (ethanol ≤30%) since 2008, which causes dramatic increases in alcohol drinking and binge drinking rates. Alcohol use in youth is the leading cause of disability adjusted life-years loss. Most adult drinkers start drinking at age 18-21. Evidence shows that alcohol brief intervention (ABI) is effective reducing hazardous and harmful alcohol use in university students. The proposed trial aims to enhance the ABI by incorporating information communication technologies (ICTs) such as instant messaging (IM) Apps (e.g. WhatsApp and WeChat) to provide personalized, real-time chat-based support led by nurses. The aims of study are as follows:
- To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary)
- To assess the effects on alcohol consumption per week at 12-month, AUDIT scores at 6 and 12-month, perceived usefulness of IM app at 12-month, intention to use IM app to reduce/quit drinking at 12-month, number of standard drinks, episode of binge drinking, episode of heavy drinking, planned drinking, Academic Role Expectation and Alcohol Scale, Alcohol Problems Scale, Patient Health Questionnaire 4-item, Perceived Stress Scale 4-item, Covid-19 related drinking behavioral changes, and self-efficacy to reduce/quit drinking at 6-month and 12-month
- To identify mediators between intervention and outcomes to inform the potential mechanisms
- To qualitatively explore experience on the interventions for reducing alcohol use and related harms
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Alcohol brief intervention, Behavioral: 12-page health warning leaflet, Behavioral: Regular messages through Instant Messaging (IM), Behavioral: Real-time chat-based support through IM Apps, Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong KongAlcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps |
| control group | Active comparator | Behavioral: Alcohol brief intervention, Behavioral: 12-page health warning leaflet, Behavioral: General health through SMS, Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong KongAlcohol brief intervention, leaflets, regular messages on general health through SMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Student aged ≥18 years from local universities in Hong Kong
- Able to read and communicate in Chinese (Cantonese or Mandarin)
- Likely to stay in Hong Kong for most of the time in the next 12 months
- Using IM Apps (WhatsApp or WeChat) installed on a smartphone
- Baseline AUDIT screening score ≥8
Key exclusion criteria (2 listed)
- Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
- Currently participating in treatments or programmes on reducing alcohol use
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 |
|---|---|---|
| Alcohol brief interventionAt baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes | Behavioural | Intervention group, control group |
| 12-page health warning leafletNurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues. | Behavioural | Intervention group, control group |
| Regular messages through Instant Messaging (IM)A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests. | Behavioural | Intervention group |
| Real-time chat-based support through IM AppsThe chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption. | Behavioural | Intervention group |
| General health through SMSAfter baseline, they will receive regular e-message through SMS with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys. | Behavioural | control group |
| AUDIT score interpretation sheet adapted from the Department of Health of Hong Konga diagram explaining drinking behaviour and potential health risks, definitions of "alcohol unit" and "binge drinking", and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women | Behavioural | Intervention group, control group |
Primary outcome
Amount of alcohol consumption per week (gram/week) at 6-month follow-up
Time frame: 6-month after baseline
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 6-month after baseline.
Compare the primary outcome using intention-to-treat (ITT), per-protocol (PP) and as-treated (AP) analysis with Compliance Average Causal Effect (CACE) analysis
Time frame: 6-month after baseline
To estimate large, moderate and null (same as the control) treatment effects and check whether ITT, AP and PP analysis estimates are biased compared with CACE estimates (alcohol consumption per week at 6-month follow-up)
29 secondary outcomes
Amount of alcohol consumption per week (gram/week) at 12-month follow-up
Time frame: 12-month after baseline
AUDIT scores at 6-month follow-up
Time frame: 6-month after baseline
AUDIT scores at 12-month follow-up
Time frame: 12-month after baseline
Number of standard drinks (10g of alcohol) per week at 6-month follow-up
Time frame: 6-month after baseline
Number of standard drinks (10g of alcohol) per week at 12-month follow-up
Time frame: 12-month after baseline
Episode of binge drinking in the past 30-day at 6-month follow up
Time frame: at 6-month after baseline
Episode of binge drinking in the past 30-day at 12-month follow up
Time frame: at 12-month after baseline
Episode of heavy drinking in the past 30-day at 6-month follow up
Time frame: at 6 -month after baseline
Episode of heavy drinking in the past 30-day at 12-month follow up
Time frame: at 12-month after baseline
Planned drinking measured in the coming 30-day at 6-month follow up
Time frame: at 6-month after baseline
Planned drinking measured in the coming 30-day at 12-month follow up
Time frame: at 12-month after baseline
Academic Role Expectation and Alcohol Scale at 6-month follow-up
Time frame: at 6-month after baseline
Academic Role Expectation and Alcohol Scale at 12-month follow-up
Time frame: at 12-month after baseline
Alcohol Problems Scale at 6-month follow-up
Time frame: at 6-month after baseline
Alcohol Problems Scale at 12-month follow-up
Time frame: at 12- month after baseline
Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month
Time frame: at 12- month after baseline
Subgroup analysis of baseline intention to quit/reduce drinking
Time frame: at 12- month after baseline
Content analysis of IM Apps conversation using alcohol BCT taxonomy
Time frame: at 12- month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 6-month
Time frame: at 6-month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 12-month
Time frame: at 12-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 6-month
Time frame: at 6-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 12-month
Time frame: at 12-month after baseline
Perceived usefulness of IM app intervention at 12-month
Time frame: at 12-month after baseline
Intention to continue using IM app intervention at 12-month
Time frame: at 12-month after baseline
Self-efficacy to reduce/quit drinking at 6-month
Time frame: at 6-month after baseline
Self-efficacy to reduce/quit drinking at 12-month
Time frame: at 12-month after baseline
Covid-19 related drinking behavioral changes at baseline
Time frame: at baseline
Covid-19 related drinking behavioral changes at 6-month
Time frame: at 6-month
Covid-19 related drinking behavioral changes at 12-month
Time frame: at 12-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 24586936Thomas GN, Wang MP, Ho SY, Mak KH, Cheng KK, Lam TH. Adverse lifestyle leads to an annual excess of 2 million deaths in China. PLoS One. 2014 Feb 26;9(2):e89650. doi: 10.1371/journal.pone.0089650. eCollection 2014.
- Background: PubMed 21652063Gore FM, Bloem PJ, Patton GC, Ferguson J, Joseph V, Coffey C, Sawyer SM, Mathers CD. Global burden of disease in young people aged 10-24 years: a systematic analysis. Lancet. 2011 Jun 18;377(9783):2093-102. doi: 10.1016/S0140-6736(11)60512-6. Epub 2011 Jun 7.
- Background: PubMed 23793697Wang MP, Ho SY, Lam TH. Underage alcohol drinking and medical services use in Hong Kong: a cross-sectional study. BMJ Open. 2013 May 28;3(5):e002740. doi: 10.1136/bmjopen-2013-002740.
- Background: PubMed 27177803Huang R, Ho SY, Wang MP, Lo WS, Lam TH. Reported alcohol drinking and mental health problems in Hong Kong Chinese adolescents. Drug Alcohol Depend. 2016 Jul 1;164:47-54. doi: 10.1016/j.drugalcdep.2016.04.028. Epub 2016 Apr 25.
- BackgroundDepartment of Health. Report of population health survey 2014/15, Hong Kong SAR; 2018. Retrived at 24 Oct 2018 from: https://www.chp.gov.hk/en/static/51256.html
- Background: PubMed 29476653Kaner EF, Beyer FR, Muirhead C, Campbell F, Pienaar ED, Bertholet N, Daeppen JB, Saunders JB, Burnand B. Effectiveness of brief alcohol interventions in primary care populations. Cochrane Database Syst Rev. 2018 Feb 24;2(2):CD004148. doi: 10.1002/14651858.CD004148.pub4.
- Background: PubMed 22967716Fachini A, Aliane PP, Martinez EZ, Furtado EF. Efficacy of brief alcohol screening intervention for college students (BASICS): a meta-analysis of randomized controlled trials. Subst Abuse Treat Prev Policy. 2012 Sep 12;7:40. doi: 10.1186/1747-597X-7-40.
- Background: PubMed 28944453Kaner EF, Beyer FR, Garnett C, Crane D, Brown J, Muirhead C, Redmore J, O'Donnell A, Newham JJ, de Vocht F, Hickman M, Brown H, Maniatopoulos G, Michie S. Personalised digital interventions for reducing hazardous and harmful alcohol consumption in community-dwelling populations. Cochrane Database Syst Rev. 2017 Sep 25;9(9):CD011479. doi: 10.1002/14651858.CD011479.pub2.
- Background: PubMed 19006997Larimer ME, Cronce JM, Lee CM, Kilmer JR. Brief intervention in college settings. Alcohol Res Health. 2004-2005;28(2):94-104.
- Background: PubMed 11964101Moyer A, Finney JW, Swearingen CE, Vergun P. Brief interventions for alcohol problems: a meta-analytic review of controlled investigations in treatment-seeking and non-treatment-seeking populations. Addiction. 2002 Mar;97(3):279-92. doi: 10.1046/j.1360-0443.2002.00018.x.
- Background: PubMed 27310031Fowler LA, Holt SL, Joshi D. Mobile technology-based interventions for adult users of alcohol: A systematic review of the literature. Addict Behav. 2016 Nov;62:25-34. doi: 10.1016/j.addbeh.2016.06.008. Epub 2016 Jun 7.
- Background: PubMed 19752409Kypri K, Hallett J, Howat P, McManus A, Maycock B, Bowe S, Horton NJ. Randomized controlled trial of proactive web-based alcohol screening and brief intervention for university students. Arch Intern Med. 2009 Sep 14;169(16):1508-14. doi: 10.1001/archinternmed.2009.249.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol brief intervention, 12-page health warning leaflet and Regular messages through Instant Messaging (IM) in people with Alcohol Misuse, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2021. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siu Long Chau, PhD (+852-39176981, h1357885@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of alcohol consumption per week (gram/week) at 6-month follow-up (time frame: 6-month after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04025151, which also lists 20 linked publications.
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 13 Sep 2021.