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

Not Applicable

• Conditions: Alcohol Misuse
• Interventions: Behavioral: Alcohol brief intervention; Behavioral: 12-page health warning leaflet; Behavioral: Regular messages through Instant Messaging (IM); Behavioral: General health through SMS; Behavioral: Real-time chat-based support through IM Apps; Behavioral: AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong

• Registration Number: NCT04025151
• Lead Sponsor: The University of Hong Kong

Brief 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.

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 Timeline

• Study First Submitted: 2019-07-16
• Study First Submitted QC: 2019-07-16
• Study First Posted: 2019-07-18
• Study Start: 2020-09-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-13
• Primary Completion: 2022-09-30
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 770

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Alcohol brief intervention	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	Regular messages through Instant Messaging (IM)	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	12-page health warning leaflet	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
Intervention group	Real-time chat-based support through IM Apps	Alcohol brief intervention, leaflets, regular personalized messages on ABI through IM Apps, real-time chat-based support through IM Apps
control group	12-page health warning leaflet	Alcohol brief intervention, leaflets, regular messages on general health through SMS
control group	General health through SMS	Alcohol brief intervention, leaflets, regular messages on general health through SMS
control group	Alcohol brief intervention	Alcohol brief intervention, leaflets, regular messages on general health through SMS
control group	AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong	Alcohol brief intervention, leaflets, regular messages on general health through SMS

Primary Outcome Measures

Name	Time	Method
Amount of alcohol consumption per week (gram/week) at 6-month follow-up	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	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)

Secondary Outcome Measures

Name	Time	Method
AUDIT scores at 12-month follow-up	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.
Episode of heavy drinking in the past 30-day at 6-month follow up	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
Episode of binge drinking in the past 30-day at 12-month follow up	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
Planned drinking measured in the coming 30-day at 6-month follow up	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
Planned drinking measured in the coming 30-day at 12-month follow up	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
Alcohol Problems Scale at 12-month follow-up	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
Patient Health Questionnaire 4-item (PHQ-4) at 12-month	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
Amount of alcohol consumption per week (gram/week) at 12-month follow-up	12-month after baseline	Assessed by unit in gram and compare the alcohol consumption between intervention and control group at 12-month after baseline.
AUDIT scores at 6-month follow-up	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.
Number of standard drinks (10g of alcohol) per week at 6-month follow-up	6-month after baseline	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 6-month
Covid-19 related drinking behavioral changes at 6-month	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
Number of standard drinks (10g of alcohol) per week at 12-month follow-up	12-month after baseline	Assessed by either increase or decrease in standard drinks number and compared between intervention and control group at 12-month
Episode of binge drinking in the past 30-day at 6-month follow up	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
Self-efficacy to reduce/quit drinking at 12-month	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
Episode of heavy drinking in the past 30-day at 12-month follow up	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
Academic Role Expectation and Alcohol Scale at 12-month follow-up	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
Mediation analysis of variables at 6-month on weekly amount of alcohol consumption at 12-month	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
Content analysis of IM Apps conversation using alcohol BCT taxonomy	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
Patient Health Questionnaire 4-item (PHQ-4) at 6-month	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
Perceived Stress Scale 4-item (PSS-4) at 12-month	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
Perceived usefulness of IM app intervention at 12-month	at 12-month after baseline	Score ranges from 0 to 10 with higher score indicates a higher level of usefulness of our intervention.
Covid-19 related drinking behavioral changes at baseline	at baseline	Assessed by stop drinking, increase (+50%), slight increase, decrease (-50%), slight decrease or no change of drinking after the start of pandemic
Academic Role Expectation and Alcohol Scale at 6-month follow-up	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
Perceived Stress Scale 4-item (PSS-4) at 6-month	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
Self-efficacy to reduce/quit drinking at 6-month	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
Covid-19 related drinking behavioral changes at 12-month	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
Alcohol Problems Scale at 6-month follow-up	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
Subgroup analysis of baseline intention to quit/reduce drinking	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
Intention to continue using IM app intervention at 12-month	at 12-month after baseline	Ask for intention to use (yes/no) IM app intervention to reduce/quit drinking at 12-month

Trial Locations

Locations (1)

School of Nursing, The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong