Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students

September 2, 2021 updated by: Dr. Wang Man-Ping, The University of Hong Kong

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.

Study Overview

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:

  1. To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary)
  2. 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
  3. To identify mediators between intervention and outcomes to inform the potential mechanisms
  4. To qualitatively explore experience on the interventions for reducing alcohol use and related harms

Study Type

Interventional

Enrollment (Anticipated)

770

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong, 000000
        • Recruiting
        • School of Nursing, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
  • Currently participating in treatments or programmes on reducing alcohol use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention group
Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
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
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.
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.
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.
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
ACTIVE_COMPARATOR: control group
Alcohol brief intervention, leaflets, regular messages on general health through SMS
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
6-month after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of alcohol consumption per week (gram/week) at 12-month follow-up
Time Frame: 12-month after baseline
Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.
12-month after baseline
AUDIT scores at 6-month follow-up
Time Frame: 6-month after baseline
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.
6-month after baseline
AUDIT scores at 12-month follow-up
Time Frame: 12-month after baseline
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.
12-month after baseline
Number of standard drinks (10g of alcohol) per week at 6-month follow-up
Time Frame: 6-month after baseline
Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month
6-month after baseline
Number of standard drinks (10g of alcohol) per week at 12-month follow-up
Time Frame: 12-month after baseline
Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month
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
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
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
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
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
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
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
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
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
Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 6-month follow-up questionnaires
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
Compare the number of planned drinking (yes or no) between intervention group and control group at baseline and 12-month follow-up questionnaires
at 12-month after baseline
Academic Role Expectation and Alcohol Scale at 6-month follow-up
Time Frame: at 6-month after baseline
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
at 6-month after baseline
Academic Role Expectation and Alcohol Scale at 12-month follow-up
Time Frame: at 12-month after baseline
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
at 12-month after baseline
Alcohol Problems Scale at 6-month follow-up
Time Frame: at 6-month after baseline
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
at 6-month after baseline
Alcohol Problems Scale at 12-month follow-up
Time Frame: at 12- month after baseline
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
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
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
at 12- month after baseline
Subgroup analysis of baseline intention to quit/reduce drinking
Time Frame: at 12- month after baseline
Subgroup analysis to check whether the intervention is more effective with participants with intention to quit/reduce drinking on outcomes
at 12- month after baseline
Content analysis of IM Apps conversation using alcohol BCT taxonomy
Time Frame: at 12- month after baseline
The conversations between the participants and the nurse will be analyzed and categorized into different sub-type of BCT taxonomy
at 12- month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 6-month
Time Frame: at 6-month after baseline

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

at 6-month after baseline
Patient Health Questionnaire 4-item (PHQ-4) at 12-month
Time Frame: at 12-month after baseline

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

at 12-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 6-month
Time Frame: at 6-month after baseline

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

at 6-month after baseline
Perceived Stress Scale 4-item (PSS-4) at 12-month
Time Frame: at 12-month after baseline

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

at 12-month after baseline
Perceived usefulness of IM app intervention at 12-month
Time Frame: at 12-month after baseline
Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.
at 12-month after baseline
Intention to continue using IM app intervention at 12-month
Time Frame: at 12-month after baseline
Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month
at 12-month after baseline
Self-efficacy to reduce/quit drinking at 6-month
Time Frame: at 6-month after baseline

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

at 6-month after baseline
Self-efficacy to reduce/quit drinking at 12-month
Time Frame: at 12-month after baseline

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

at 12-month after baseline
Covid-19 related drinking behavioral changes at baseline
Time Frame: at baseline
Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic
at baseline
Covid-19 related drinking behavioral changes at 6-month
Time Frame: 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
at 6-month
Covid-19 related drinking behavioral changes at 12-month
Time Frame: 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
at 12-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2020

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

July 16, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (ACTUAL)

July 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2021

Last Update Submitted That Met QC Criteria

September 2, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chat-based ABI (UniStudents)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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